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Journal articles on the topic 'Marketing Authorization Application'

Author: Grafiati

Published: 10 September 2021

Last updated: 30 July 2025

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1

Slevin, Lindi, Reza Shojanoori, and Radmila Juric. "DEVELOPING A DATABASE FOR AUTOMATING REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY." Journal of Integrated Design and Process Science: Transactions of the SDPS, Official Journal of the Society for Design and Process Science 9, no. 4 (2005): 1–11. http://dx.doi.org/10.3233/jid-2005-9401.

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The complex procedure of processing the marketing authorization of medicinal product licenses is a challenging task for government health authorities and the pharmaceutical industry across the world. Regulatory requirements have diverged significantly, and each country has its own regulations and procedures for marketing authorizations. The automation of and adequate software support for such procedures are critical factors that can improve the efficiency of regulatory authorities. In this paper we report on the design and implementation of a database whose role is to (a) support the automatio

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C., Bhave, Dolhare N., and J. K. Badjatya. "MARKETING AUTHORIZATION APPLICATION (MAA) FOR EUROPE MARKET." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 88–91. http://dx.doi.org/10.22270/ijdra.v3i1.160.

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This article states requirement of Marketing Authorization Application to get registration of Drug Product to EEA. The procedures for application of marketing authorization are: Centralised procedure, National procedure, Mutual recognition procedure, Decentralised procedure.

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Sathyalakshmi Ramesh and Sowmya Cherukuri. "The European Union’s current regulations for the licensing of generic and hybrid medications." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 105–10. http://dx.doi.org/10.30574/wjbphs.2023.13.2.0233.

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In the European Union, the applicant must specify the legal justification for the application in any Marketing Authorization Application (MAA) for a pharmaceutical product. The dossier's content and the market exclusivity are significantly influenced by this legal foundation, which is outlined in Directive 2001/83/EC as modified. The right legal foundation must be chosen carefully for new development projects involving active chemicals that are already known, including novel strengths, dosage forms, administration methods, and indications. In accordance with Article 10 and the so-called "hybri

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Sathyalakshmi, Ramesh, and Cherukuri Sowmya. "The European Union's current regulations for the licensing of generic and hybrid medications." World Journal of Biology Pharmacy and Health Sciences 13, no. 2 (2023): 105–10. https://doi.org/10.5281/zenodo.7948643.

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In the European Union, the applicant must specify the legal justification for the application in any Marketing Authorization Application (MAA) for a pharmaceutical product. The dossier's content and the market exclusivity are significantly influenced by this legal foundation, which is outlined in Directive 2001/83/EC as modified. The right legal foundation must be chosen carefully for new development projects involving active chemicals that are already known, including novel strengths, dosage forms, administration methods, and indications. In accordance with Article 10 and the so-called &q

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Carmo, Ana Cerúlia Moraes do, Stefânia Schimaneski Piras, Nayrton Flávio Moura Rocha, and Tais Gratieri. "Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)." BioMed Research International 2017 (2017): 1–10. http://dx.doi.org/10.1155/2017/7894937.

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Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company’s administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal.Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 20

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Gupta, Rajkumar. "INSIDE STORY FOR REVIEW OF AN ABBREVIATED NEW DRUG APPLICATION." International Journal of Drug Regulatory Affairs 2, no. 1 (2018): 29–31. http://dx.doi.org/10.22270/ijdra.v2i1.122.

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ANDA constitutes an important submission for marketing authorization of generic drugs. The FDA has recently mandated an electronic submission in the form of eCTD for the same. ANDA application is quite complex with respect to patent rights and BE evaluations. The incomplete applications are often refused to file and the accepted applications some time get disqualified due to technical deficiencies at the manufacturing site. Recently FDA has rejected many ANDA applications in ASEAN region on account of data integrity.

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D., Sarika Prathyusha* Brahmaiah Bonthagarala M.V. Ngabhushanam and D. Nagarjuna Reddy. "MARKETING AUTHORIZATION PROCESS OF NEW DRUG SUBSTANCES IN U.S.A AND EUROPE." Indo American Journal of Pharmaceutical Sciences 04, no. 06 (2017): 1690–98. https://doi.org/10.5281/zenodo.821854.

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A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This work focuses on the drug approval process in India. Develop

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Chakraborty, Krishnasis. "A New Drug Approval Process in Europe: A Review." International Journal of Drug Regulatory Affairs 7, no. 3 (2019): 21–29. http://dx.doi.org/10.22270/ijdra.v7i3.332.

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Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for Marketing Authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and Regulatory requirements according to European Medical Agency (EMA) (1).

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Haishi, Yu, Jiang Yingzhu, and Zhou Weijun. "Status Analysis on the Marketing Authorization Holder of China's Drugs." E3S Web of Conferences 185 (2020): 04009. http://dx.doi.org/10.1051/e3sconf/202018504009.

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We analyze the basic situation of Marketing Authorization Holder (MAH) of drugs in China. Mathematical analysis was carried out on the approval time, product category, dosage form, listing permit holder and production unit of 3239 MAH of drugs in China as of July 31, 2019. We found the following results. The approval time for MAH of drugs was concentrated in 2015, mainly based on chemicals, and the dosage forms were mostly tablets and injections. Furthermore, the number of MAH of drugs varies greatly among different provinces, and the number of Hebei, Guangdong, and Jiangsu ranks in the top th

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Kelly, L., M. Lazzaro, and C. Petersen. "Canadian Drug Regulatory Framework." Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques 34, S1 (2007): S3—S10. http://dx.doi.org/10.1017/s0317167100005485.

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The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context- based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what “authorization to market a drug in Canada” means, in terms of the role of the sponsor, the responsibility of Health Canada

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Homeniuk, Anastasiia. "Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine." Theory and Practice of Intellectual Property, no. 6 (December 27, 2021): 111–19. http://dx.doi.org/10.33731/62021.249108.

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Keywords: supplementary protection certificate, basic patent, procedure for obtainingsupplementary protection certificate Key issues of legal regulation of the supplementary protection of inventionsin the field of pharmacy in the national legislation of UkraineThe article is devoted to the study of key issues of legal regulation of supplementaryprotection of inventions after the adoption of the Law of Ukraine «On Amendmentsto Certain Legislative Acts of Ukraine on Patent Legislation Reform» in the absenceof bylaws to regulate the procedure for issuing supplementary protection certificate

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Embleton-Thirsk, Andrew, Elizabeth Deane, Stephen Townsend, et al. "Impact of retrospective data verification to prepare the ICON6 trial for use in a marketing authorization application." Clinical Trials 16, no. 5 (2019): 502–11. http://dx.doi.org/10.1177/1740774519862528.

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Background: The ICON6 trial (ISRCTN68510403) is a phase III academic-led, international, randomized, three-arm, double-blind, placebo-controlled trial of the addition of cediranib to chemotherapy in recurrent ovarian cancer. It investigated the use of placebo during chemotherapy and maintenance (arm A), cediranib alongside chemotherapy followed by placebo maintenance (arm B) and cediranib throughout both periods (arm C). Results of the primary comparison showed a meaningful gain in progression-free survival (time to progression or death from any cause) when comparing arm A (placebo) with arm C

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Gjeorgiev, Blagoj, Dijana Miceva, Dino Karpicarov, et al. "A comparative study of the procedures for medicine approval in the European Union and the United States." Arhiv za farmaciju 75, no. 2 (2025): 101–13. https://doi.org/10.5937/arhfarm75-55555.

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Medicine registration refers to evaluating a medical product's safety, efficacy, and quality, leading to the granting of a Marketing Authorization. Given the intense globalization of the pharmaceutical industry, harmonizing regulatory procedures between the European Medicines Agency (EMA) and the United States's Food and Drug Administration (FDA) is critical for accelerating the availability of new medicines. The EMA oversees three different procedures for medicine registration: Centralized, Decentralized and Mutual Recognition Procedure. Conversely, the FDA offers three registration applicati

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Jachimowicz, Michał, Cezary Pruszko, and Karolina Dziadek. "PD205 “Medical Fund” – A Novel Approach To Granting Individuals Access To Cutting-Edge Therapies." International Journal of Technology Assessment in Health Care 40, S1 (2024): S171. https://doi.org/10.1017/s0266462324004276.

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IntroductionAccess to innovative and expensive medicines is a significant challenge for Poland’s healthcare system. These therapies often do not meet the reimbursement criterion that is currently set at three times the gross domestic product per capita. Nevertheless, there are ongoing efforts to identify funds that can cover the cost of innovative and expensive medicines.MethodsA new legal act established the Medical Fund, which is an addition to the regular National Health Fund. The Medical Fund finances medical technologies recognized by the Polish healthcare system as highly innovative or o

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Parth, Killedar* Tanuja Khopade Siddhi Kurhade Nutan Kokare Shubhangi Khemnar S. D. Mankar. "Comparative Study of Regulatory Requirements for Drug Approval (USFDA vs. EMA vs. INDIA)." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 3002–13. https://doi.org/10.5281/zenodo.15276998.

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Before a new drug can be approved for import or manufacturing, it must be proven safe and effective for humans. Every nation has a regulatory body that examines research data to ensure the medication complies with safety and efficacy standards for public health. The regulatory affairs division of a company plays an essential role in guaranteeing adherence to the laws, regulations, and guidelines established by different regulatory authorities in other countries.[1] This article seeks to examine the different facets of the drug authorization procedure in the USA, Europe, and India. Current limi

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Chamberlain, Paul. "Effective presentation of immunogenicity risk assessments and related data in regulatory dossiers." Bioanalysis 11, no. 17 (2019): 1581–92. http://dx.doi.org/10.4155/bio-2018-0209.

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The purpose of this article is to provide practical advice about how to present immunogenicity-related information in regulatory dossiers, with a particular focus on a model for an Integrated Summary of Immunogenicity to be submitted in the marketing authorization application for novel biopharmaceutical products in ICH regions (EU, USA and Japan). A format that links the analysis of potential risk factors to a justification of the methodology applied for risk evaluation and conclusions for risk mitigation is presented as a model that can be adapted according to the weight of evidence to be sub

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Yadav, Dr N. Sudhakar, Dr Ch Mallikarjuna Rao, Dr D. V. Lalitha Parameswari, Dr K. L. S. Soujanya, and Dr Challa Madhavi Latha. "Accessing Cloud Services Using Token based Framework for IoT Devices." Webology 18, no. 2 (2021): 199–211. http://dx.doi.org/10.14704/web/v18i2/web18316.

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Nowadays cloud environments are used by many business service sectors like healthcare, retail marketing, banking, and many business fields. At the same time, the usage of Internet of Things (IoT) devices in different sectors also increasing tremendously. So, there is a general problem for securing any business service in enterprise cloud environments restricting by only authorized devices. We are proposing cryptographic techniques with the help of a token-based framework by enabling a secure handshake between consuming applications and the source business service which aims to authorize the ta

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Lino, Maria Maddalena, Susan Mather, Marianna Trani, Yan Chen, Patrick Caubel, and Barbara De Bernardi. "Challenges and Innovations in Pharmacovigilance and Signal Management During the COVID-19 Pandemic: An Industry Perspective." Vaccines 13, no. 5 (2025): 481. https://doi.org/10.3390/vaccines13050481.

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Vaccine marketing authorization holders (MAHs) are responsible for the conduction of global vaccine pharmacovigilance on their vaccine products. A safety signal is detected when a new adverse event (AE) or aspect of an AE occurs after exposure to the vaccine and warrants further investigation to determine whether a causal association may exist. Signal detection and evaluation (signal management) begins at the start of vaccine development, before an MAH submits an application for authorization to regulatory authorities, continues through the course of all clinical trials, and carries on beyond

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McKenna, Kevin. "An Overview and Comparison of the US and EEC Chemical and Pharmaceutical Requirements for the Marketing Authorization/New Drug Application." Drug Information Journal 23, no. 3 (1989): 371–77. http://dx.doi.org/10.1177/009286158902300307.

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Noguera Peña, Alfonso. "Innovation in the future Pharmaceutical Legislation of the European Union." Anales de la Real Academia Nacional de Farmacia 90, no. 90(04) (2025): 499–526. https://doi.org/10.53519/analesranf.2024.90.04.06.

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The European Commission, within the framework of the implementation of the Pharmaceutical Strategy for Europe, has recently published a regulatory package that will replace the current regulation of medicines for human use in the European Union and that aims to provide a global response to current challenges. that the pharmaceutical sector faces. Due to the relevant role that innovation plays in the future regulatory framework, our work delves into the main measures that affect the promotion of research and development and, in particular: (i) regulatory data protection periods, (ii) the approa

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Santana, Ricardo, Enrique Onieva, Robin Zuluaga, Aliuska Duardo-Sánchez, and Piedad Gañán. "The Role of Machine Learning in Centralized Authorization Process of Nanomedicines in European Union." Current Topics in Medicinal Chemistry 21, no. 9 (2021): 828–38. http://dx.doi.org/10.2174/1568026621666210319101847.

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Background: Machine Learning (ML) has experienced an increasing use, given the possibilities to expand the scientific knowledge of different disciplines, such as nanotechnology. This has allowed the creation of Cheminformatic models capable of predicting biological activity and physicochemical characteristics of new components with high success rates in training and test partitions. Given the current gaps of scientific knowledge and the need for efficient application of medicines products law, this paper analyzes the position of regulators for marketing medicinal nanoproducts in the European U

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Vogel, Andreas M. "Hybrid or Mixed Marketing Authorization Application in the European Union: Not a Trivial Decision in New Development Programs for Established Drugs." Drug Information Journal 46, no. 4 (2012): 479–84. http://dx.doi.org/10.1177/0092861512443748.

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Annur, Syarah Zahira, and Abdul Roup. "Tinjauan Atas Prosedur Pengajuan Hingga Pembayaran Klaim Asuransi Kendaraan Bermotor." Jurnal Aplikasi Bisnis Kesatuan 4, no. 3 (2024): 425–38. http://dx.doi.org/10.37641/jabkes.v4i3.1888.

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The development of the number of vehicles is inseparable from the risk of uncertainty that lurks. Therefore, motor vehicle insurance is present as a place to transfer risk from unexpected things that happen to vehicles, or to parties included in the policy. The accounting information system exists because of the need to monitor business activities. In submitting an insurance claim, a procedure is needed regarding the claim submission flow to facilitate the company and monitor the company's performance. The purpose of this review is to determine the application of the system in the procedure fo

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Stawarska, Agnieszka, Magdalena Bamburowicz-Klimkowska, Elise Runden-Pran, et al. "Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products." International Journal of Molecular Sciences 25, no. 12 (2024): 6533. http://dx.doi.org/10.3390/ijms25126533.

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Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular ve

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Burri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341324.

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<em>Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authoriza

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Burri, Padmaja* M. V. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G.Ramakrishna. "DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE & INDIA." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7251–63. https://doi.org/10.5281/zenodo.1341334.

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<em>Common Technical Document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filings easier, there are significant differences in the dossier submission requirements in these countries. This study put forth the differences in registration requirements for generics in United States, Europe and India. Generic drugs in US they are approved under the Abbreviated New Drug Application. Bioavailability and Bioequivalence study data is critical in the generic drug approval process. For marketing authoriza

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Kapoor, Anjali, and Geeta Aggarwal. "Pre-filled syringes in developed and developing region: An insight into Regulatory considerations." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 42–50. http://dx.doi.org/10.22270/ijdra.v7i2.317.

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A Pre-filled syringe is a disposable syringe that is supplied already loaded with the substance to be injected. It is a unit dose of parenteral medication to which a needle has been fixed by a producer. They are small which make them easy to carry and are dependable for delivering a precise dose of medication. These reasons are leading to growth of parenteral medication in pharmaceutical market. The intent of this review article is to provide information on regulatory guidelines involved in submission approach for marketing authorization of pre-filled syringe in developed region (USA, EU) and

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Madagoni, Krishna, Uppunuri Saidireddy, and Himaja . "A review on drug approval process in US, Europe and India-dossier, bioavailability and bioequivalence studies." INTERNATIONAL JOURNAL OF APPLIED PHARMACEUTICAL SCIENCES AND RESEARCH 1, no. 04 (2017): 133–46. http://dx.doi.org/10.21477/ijapsr.v1i4.6892.

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Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (RandD) efforts of the company to the market. In the present scenario, countries have different regulatory requirements for approval of a new drug. The single regulatory approach for marketing authorization application (MAA) of a new drug product applicable to various countries (on the basis of single dossier) is utmost difficult. Therefore, the knowledge of exact and detailed regulatory requirements for MAA of each country should be known to establish a sui

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Smith, D., P. Trennery, D. Farningham, and J. Klapwijk. "The selection of marmoset monkeys (Callithrix jacchus) in pharmaceutical toxicology." Laboratory Animals 35, no. 2 (2001): 117–30. http://dx.doi.org/10.1258/0023677011911444.

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Prior to controlled clinical trials in human volunteers or patients it is required that novel pharmaceuticals are evaluated for pre-clinical safety in a rodent and a non-rodent ('second') species. In most cases the rodent species used has been the rat and the second species has been the dog or macaque (usually cynomolgus or rhesus) monkey. However, there is an increasing trend within the United Kingdom (UK) pharmaceutical industry to use the common marmoset ( Callithrix jacchus) for pre-clinical toxicology programmes. This paper examines the practicality of using the common marmoset (hencefort

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J., Neelima K. Anie Vijetha A. Srivani P. Sravanthi. "REGULATORY DOSSIER- ASEAN COMMON TECHNICAL DOCUMENT (ACTD) FOR ASEM COUNTRIES." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2018): 4790–97. https://doi.org/10.5281/zenodo.1134382.

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The Regulatory Affairs department is very often the first point of contact between the government authorities and the company. The attitudes and actions of Regulatory Affairs Professionals will condition the perceptions of the government officials to the company. Dossier is a collection or file of documents on the same subject, especially a file containing detailed information about a person or a topic. Any preparation for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient is called as “pharmaceutical product for

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Ahammad, Nisar, Nagarjuna Reddy, M. V. Nagabhushanam, and Brahmaiah Ramakrishna. "Challenges Faced During eCTD and CTD Filling Procedures for USFDA and Canada." Journal of Drug Delivery and Therapeutics 9, no. 4-s (2019): 673–79. http://dx.doi.org/10.22270/jddt.v9i4-s.3334.

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Electronic Common Technical Document (eCTD) is a topic of increasing interest in the pharmaceutical Industry as it become compulsory for filing procedures. The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used across Europe, Japan and the United States.Quality, Safety and Efficacy information is assembled in a common format through CTD .The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Electronic commo

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Makwana, Rajdeep G., Kuldeep V. Desai, Vaibhav Kikani, and Maulikkumar D. Vaja. "Regulatory advances and prospects of variation filing for the registered parenteral products in USA and Europe." International Journal of Drug Regulatory Affairs 9, no. 2 (2021): 52–65. http://dx.doi.org/10.22270/ijdra.v9i2.470.

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Drug Regulatory Affairs (DRA) is a vital unit in a pharmaceutical company. It is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safety and efficacy in pharmaceuticals, veterinary medicines, medical devices, cosmetics and complementary medicines, healthcare products to individuals around the world. Regulatory affairs (RA) professionals are employed in pharmaceutical industry, government, academic research and clinical institutions. As India is growing

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Ju, Jung Hun, Naery Lee, Sun-hee Kim, et al. "Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform." Osong Public Health and Research Perspectives 13, no. 1 (2022): 4–14. http://dx.doi.org/10.24171/j.phrp.2021.0311.

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Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. A

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Rendra, Erika, Eleonora Scaccia, and Karen Bieback. "Recent advances in understanding mesenchymal stromal cells." F1000Research 9 (February 27, 2020): 156. http://dx.doi.org/10.12688/f1000research.21862.1.

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Mesenchymal stromal cells (MSCs) are among of the most studied cell type for cellular therapy thanks to the ease of isolation, cultivation, and the high ex vivo expansion potential. In 2018, the European Medicines Agency finally granted the first marketing authorization for an MSC product. Despite the numerous promising results in preclinical studies, translation into routine practice still lags behind: therapeutic benefits of MSCs are not as satisfactory in clinical trial settings as they appear to be in preclinical models. The bench-to-bedside-and-back approach and careful evaluation of disc

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Cave, Emma. "EU Clinical Trials Regulation 2014: Fetter or facilitator?" Medical Law International 18, no. 2-3 (2018): 179–94. http://dx.doi.org/10.1177/0968533218799535.

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European Union (EU) Clinical Trials Regulation 536/2014, expected to come into force in 2019, provides for a streamlined single EU application for cross-border clinical trials and enhanced transparency of results. The status of the Regulation in post-Brexit UK is uncertain. Matters of regulatory alignment will be covered by agreements on the future EU-UK relationship. In the short term, implementation of the Regulation in the United Kingdom depends on the Brexit model and timing of the Regulation’s implementation. The EU (Withdrawal) Act will convert EU law into UK law, including the vast arra

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Wang, Valentine, Mélanie Gauthier, Véronique Decot, Loïc Reppel, and Danièle Bensoussan. "Systematic Review on CAR-T Cell Clinical Trials Up to 2022: Academic Center Input." Cancers 15, no. 4 (2023): 1003. http://dx.doi.org/10.3390/cancers15041003.

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The development of Chimeric Antigen Receptor T cells therapy initiated by the United States and China is still currently led by these two countries with a high number of clinical trials, with Europe lagging in launching its first trials. In this systematic review, we wanted to establish an overview of the production of CAR-T cells in clinical trials around the world, and to understand the causes of this delay in Europe. We particularly focused on the academic centers that are at the heart of research and development of this therapy. We counted 1087 CAR-T cells clinical trials on ClinicalTrials

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Sciberras, Josette, Raymond Zammit, and Patricia Vella Bonanno. "The European framework for intellectual property rights for biological medicines." Generics and Biosimilars Initiative Journal 10, no. 4 (2021): 172–83. http://dx.doi.org/10.5639/gabij.2021.1004.022.

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Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quan

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Manita, Aakash Deep, Vikram, A. C. Rana, Monu Yadav, and Rakesh K. Marwaha. "Regulation of Medical Devices and their Clinical Trials Studies in the USA: An Update." Recent Innovations in Chemical Engineering (Formerly Recent Patents on Chemical Engineering) 13, no. 2 (2020): 94–109. http://dx.doi.org/10.2174/2405520412666190828202733.

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Background: Need for Medical devices is very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In the USA, a regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which looks the manufacture, packaging and use of medical devices in the USA. Objective: In USA, Medical devices are classified into 3 classes: class I which look for the medical devices used for the general control as dental floss and bandages, etc., c

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Pooja Chaudhari and Jitendra Kumar Badjatya. "Good Practices in Management of deficiencies in CTD dossier and comparative study for US, EU and Australia." International Journal of Drug Regulatory Affairs 7, no. 4 (2019): 40–55. http://dx.doi.org/10.22270/ijdra.v7i4.371.

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This topic aims at reviewing the drug and drug product filing and obtaining USFDA EMEA and TGA approval and its effective role to improve the standards which are laid by them. The respective Regulatory Agency approves the new/generic drug products that govern respective market before introduction of particular product into the market. The Regulatory Agency approves the entire new drug product to be safe and effective before marketing. USFDA is the Regulatory Agency which is responsible for the regulation of food and drug product in USA. EMEA is the Regulatory Agency which is responsible for th

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Hill-Madsen, Aage. "Coherence in popularized medico-pharmaceutical reports: The case of EPAR summaries for the public." Revista de Lenguas para Fines Específicos, no. 31 (June 30, 2025): 31–61. https://doi.org/10.20420/rlfe/2025.781.

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The present article investigates a particular lay-oriented medico-pharmaceutical genre, viz. the European Public Assessment Report – summary for the public, which is a summarized version of a much longer specialized report published by the European Medicines Agency. The specialized report sets out the results of the Agency’s evaluation of a given pharmaceutical company’s application for marketing authorization of a medicinal product in EU countries. The summary for the public reports the gist of the specialized source text in a linguistic register suitable for a lay readership. However, while

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Bartling, Bastian, Johanna S. Rehfeld, Daniel Boßmann, et al. "Determination of the Structural Integrity and Stability of Polysialic Acid during Alkaline and Thermal Treatment." Molecules 25, no. 1 (2019): 165. http://dx.doi.org/10.3390/molecules25010165.

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Polysialic acid (polySia) is a linear homopolymer of varying chain lengths that exists mostly on the outer cell membrane surface of certain bacteria, such as Escherichia coli (E. coli) K1. PolySia, with an average degree of polymerization of 20 (polySia avDP20), possesses material properties that can be used for therapeutic applications to treat inflammatory neurodegenerative diseases. The fermentation of E. coli K1 enables the large-scale production of endogenous long-chain polySia (DP ≈ 130) (LC polySia), from which polySia avDP20 can be manufactured using thermal hydrolysis. To ensure adequ

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Golocorbin-Kon, Svetlana, Ivana Ilickovic, and Momir Mikov. "Reasons for and frequency of off - label drug use." Medical review 68, no. 1-2 (2015): 35–40. http://dx.doi.org/10.2298/mpns1502035g.

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Introduction. The application of drugs in accordance with the marketing authorization issued by the regulatory authority is considered on-label use, while off-label drug use frequently occurs in medical practice. It includes the application of drugs beyond approved indications, for unapproved age group, with different dosage regimens or different administration route. Medical specialists frequently prescribe an off-label drug in pediatrics, neonatology, geriatrics, psychiatry and oncology. Some countries have established registers of off-label drugs and guidelines for their prescribing and adm

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Umapathi, Uthanthi Thamizhselvi, Vijay Vijayakumar, Sivakumar Muthusamy, Vijayakumar Arumugam Ramamurthy, and Deepa Natarajan. "Regulatory requirement for Medical Devices." International Journal of Drug Regulatory Affairs 12, no. 1 (2024): 9–19. http://dx.doi.org/10.22270/ijdra.v12i1.636.

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The safety and regulatory compliance of a widely used medical device have become a growing concern among a significant population. This has raised questions about the assessment of risks, monitoring of adverse drug reactions (ADR), and overall product safety. The efficacy and safety of such medical devices heavily rely on the regulations and guidelines set forth by regulatory agencies (RAs). In the pharmaceutical industry, regulatory affairs (RA) professionals play a crucial role in overseeing the lifecycle of healthcare products. They provide strategic, tactical, and operational guidanc

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Daousani, Chrysa, and Vangelis Karalis. "Paediatric Medicines: Regulatory and Scientific Issues." Drug Research 67, no. 07 (2017): 377–84. http://dx.doi.org/10.1055/s-0043-109788.

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AbstractIn the past, dosage regimens authorized for adults were extrapolated to children relying mainly on empirical dosage adjustments. However, children are not small adults, but a distinct and heterogeneous group in terms of physiology, disease occurrence, pharmacokinetics, pharmacodynamics and also psychological, cognitive, and behavioral aspects. Even though it would be helpful to know the physiological changes and the special drug treatment needs in children, this task could not be performed due to ethical reasons. Important issues to consider for the development of paediatric drug produ

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Gherghescu, Ioana, and M. Begoña Delgado-Charro. "The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA." Pharmaceutics 13, no. 1 (2020): 48. http://dx.doi.org/10.3390/pharmaceutics13010048.

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Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has recei

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Ogunbayo, Dapo, Diarmuid Coughlan, Ross Fairbairn, and Sola Akinbolade. "OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?" International Journal of Technology Assessment in Health Care 38, S1 (2022): S21—S22. http://dx.doi.org/10.1017/s0266462322001088.

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IntroductionWhile various criteria exist to define or categorize innovative medicines as new or repurposed, to our knowledge there are no standardized systems that sufficiently capture the range of pipeline products. The National Institute for Health and Care Research Innovation Observatory (NIHR IO) undertakes routine horizon scanning to support health technology assessment (HTA) in England and maintains a comprehensive Medicines Innovation Database (MInD). The aim of this project is to develop a ‘technology type’ (new versus repurposed) classification system for application within the MInD a

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Storm, Neal E., Wen Chang, Tzu-Chieh Lin, et al. "A Novel Case Study of the Use of Real-World Evidence to Support the Registration of an Osteoporosis Product in China." Therapeutic Innovation & Regulatory Science 56, no. 1 (2021): 137–44. http://dx.doi.org/10.1007/s43441-021-00342-4.

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AbstractOn June 23, 2020, Prolia® (denosumab) was approved by the National Medical Products Administration (NMPA) in the People’s Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is 普罗力, a transliteration from the English name “Prolia”, which has an implied meaning of “to give strength to everyone”— a suitable name for a potent anti-resorptive therapy. The approval was supported by a novel marketing authorization application (MAA) that included data from Prolia’s global clinical t

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Huber, Cynthia, Tim Friede, Julia Stingl, and Norbert Benda. "Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection." Therapeutic Innovation & Regulatory Science 56, no. 2 (2021): 244–54. http://dx.doi.org/10.1007/s43441-021-00352-2.

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Abstract Background Modern personalized medicine strategies builds on therapy companion diagnostics to stratify patients into subgroups with differential benefit/risk. In general, stratification for drug response implies a treatment-by-subgroup interaction. This interaction is usually suggested by the drug’s mechanism of action and investigated in pharmacological research or in clinical studies. In these candidate genes or pathway approaches, either biological reasons for a differential benefit/risk or statistical interaction regarding a pharmacological or clinical endpoint or both may be give

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Henry Miranda, Marlon Ramcy, Narayana Charyulu R, Jobin Jose, and Sandeep DS. "Current Regulations for Marketing Authorization and Procedure for Filing of Active Substance Master File (ASMF) in European Union: A Case Study." Research Journal of Pharmacy and Technology, May 30, 2022, 2070–76. http://dx.doi.org/10.52711/0974-360x.2022.00342.

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Active Pharmaceutical Ingredient is an ingredient in a drug product that is biologically active. A Drug Product will contain two components, one is the Active Ingredient and the other is the Excipients part. Drug Product that has to be placed in the European market needs to have a marketing authorization. Marketing Authorization is the process in which the drug product is evaluated for its safety and compliance with the standards laid down by the Regulatory Authority, considering the safety of patients and public. There are different Procedures for the application of Marketing Authorization. A

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Bernabe, Rosemarie D. L. C., Ghislaine J. M. W. van Thiel, Nancy S. Breekveldt, Christine C. Gispen, and Johannes J. M. van Delden. "Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?" BMC Medical Ethics 21, no. 1 (2020). http://dx.doi.org/10.1186/s12910-020-00543-w.

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Abstract Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. Methods To gather data, we used the Dutch Medicines Evaluat

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