Log in

Relevant bibliographies by topics / Dossier Registration / Journal articles

To see the other types of publications on this topic, follow the link: Dossier Registration.

Journal articles on the topic 'Dossier Registration'

Author: Grafiati

Published: 5 June 2025

Last updated: 1 August 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the top 50 journal articles for your research on the topic 'Dossier Registration.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Browse journal articles on a wide variety of disciplines and organise your bibliography correctly.

1

Mallol, J. "Registration dossier for radiopharmaceutical products." Pharmaceuticals, Policy and Law 17, no. 1,2 (2015): 213–20. http://dx.doi.org/10.3233/ppl-140408.

Full text

APA, Harvard, Vancouver, ISO, and other styles

2

Lobovikova, O. A., I. V. Shul'gina, E. G. Abramova, et al. "REGISTRATION DOCUMENTATION AND AMENDMENTS TO IT AS AN ELEMENT OF A QUALITY MANAGEMENT SYSTEM IN PRODUCTION OF ANTI-RABIES IMMUNOGLOBULIN (REVIEW)." Drug development & registration 8, no. 1 (2019): 92–96. http://dx.doi.org/10.33380/2305-2066-2019-8-1-92-96.

Full text

Abstract:

Introduction. Documentation is an integral part of the quality management system, a key element of production and quality control of medicines. A necessary condition for the Rules of good manufacturing practice and guaranteed production of quality products is compliance with the requirements set out in the documents of the registration dossier for the drug. During the life cycle of a drug, post-registration changes in the dossier may be required. Text. This work is an analytical review of changes in the documents of the registration dossier for the drug «Immunoglobulin antirabic from horse blo

APA, Harvard, Vancouver, ISO, and other styles

3

Keloth Mounika, Y. Sirisha, and K. Nagasree. "Planning and execution of dossier compilation of countries Germany, Canada and Australia." International Journal of Allied Medical Sciences and Clinical Research 11, no. 4 (2023): 405–12. http://dx.doi.org/10.61096/ijamscr.v11.iss4.2023.405-412.

Full text

Abstract:

To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. When submitting your drug benefit assessments to the German Authority or other (foreign) regula

APA, Harvard, Vancouver, ISO, and other styles

4

Godiyal, Shrikant. "Regulatory requirements for preparation of Dossier for registration of Pharmaceutical products in ACTD & CTD format." International Journal of Drug Regulatory Affairs 7, no. 2 (2019): 51–61. http://dx.doi.org/10.22270/ijdra.v7i2.318.

Full text

Abstract:

To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. This agreed upon common format in the form of CTD format and ACTD format for the technical docu

APA, Harvard, Vancouver, ISO, and other styles

5

Snegireva, I. I., E. O. Zhuravleva, and N. Yu Velts. "Expert Evaluation of Pharmacovigilance System Documents Included in the Registration Dossier." Safety and Risk of Pharmacotherapy 8, no. 4 (2020): 191–97. http://dx.doi.org/10.30895/2312-7821-2020-8-4-191-197.

Full text

Abstract:

The Russian Federation and the member states of the Eurasian Economic Union (EAEU) are working on the creation of a common pharmaceutical market. EAEU marketing authorisation may be granted to those pharmaceutical companies whose activities comply with the Good Pharmacovigilance Practice (GVP). The aim of the study was to analyse pharmacovigilance system documents submitted as part of registration dossiers of medicines and to identify problems that may arise during preparation of the pharmacovigilance system master file (PSMF). The authors analysed the PSMF, which makes part of the registratio

APA, Harvard, Vancouver, ISO, and other styles

6

Margerison, Richard. "Recommendations for a Truly International Registration Dossier." Drug Information Journal 23, no. 3 (1989): 417–20. http://dx.doi.org/10.1177/009286158902300314.

Full text

APA, Harvard, Vancouver, ISO, and other styles

7

Pihwal, Kapil, Neelam Pawar, Sheikh Aamir, Mohammad Shahbaz Alam, and Vikas Rathee. "A Comprehensive Review of Regulatory Requirements and Registration Process of Pharmaceutical Drug Products in CIS Countries." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 3 (2020): 162–76. http://dx.doi.org/10.2174/2213476x07666200708105237.

Full text

Abstract:

Background: The CIS region has a potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which require different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The r

APA, Harvard, Vancouver, ISO, and other styles

8

Shulgina, I. V., O. A. Lobovikova, O. A. Voloh та ін. "Review of Post-registration Changes in the Life Cycle of Сholera Bivalent Chemical Vaccine (Review)". Drug development & registration 9, № 1 (2020): 109–14. http://dx.doi.org/10.33380/2305-2066-2020-9-1-109-114.

Full text

Abstract:

Introduction. The inevitable of post-registration variations due to the improvement of production processes and quality control related to the integration of the modern technological solutions, replacement of equipment, suppliers of raw, consumables and packaging materials, improvement of form release or composition, administrative changes, as well as obtaining new data on clinical efficacy and safety of immunobiological medicinal products (IMP) during post-marketing studies.Text. The purpose of this work is to analyze the post-registration changes in the life cycle of IMP «Сholera bivalent ch

APA, Harvard, Vancouver, ISO, and other styles

9

Singam, Sri Lakshmi Sowjanya Reddy, Koushik Yetukuri, and Rama Rao Nadendla. "Drug Registration requirements for Pharmaceuticals in Emerging markets." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 73–82. http://dx.doi.org/10.22270/ijdra.v8i4.442.

Full text

Abstract:

Registration of pharmaceutical drug products in emerging market is maximum worrying task. Although the requirements are harmonized in regulated international locations by way of CTD (Common technical document) submitting, yet others have considerable diversity in necessities. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe collectively for various factors of drug registration. But there is no such harmonized guideline for rising ma

APA, Harvard, Vancouver, ISO, and other styles

10

Foteeva, A. V., O. S. Barshadskaya, and N. B. Rostova. "Description of the System of State Registration of Medicines in the Republic of Georgia as a Development Potential of Domestic Manufacturers." Drug development & registration 10, no. 2 (2021): 155–61. http://dx.doi.org/10.33380/2305-2066-2021-10-2-155-161.

Full text

Abstract:

Introduction. One of the main business objectives of Russian pharmaceutical companies is export development. To obtain marketing authorization in countries with a good potential for business it is of greater importance to be competent in drugs registration procedure.Aim. The purpose of this study is to overview general aspects of registration procedure for generic drugs in Georgia for potential launching on pharmaceutical market.Materials and methods. For research purposes we have utilized data obtained from research articles, official websites, regulatory documents for drug registration proce

APA, Harvard, Vancouver, ISO, and other styles

11

Badjatya, Jitendra Kumar, Anil Jangid, Prakash Dodiya, et al. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 10, no. 1 (2022): 51–82. http://dx.doi.org/10.22270/ijdra.v10i1.510.

Full text

Abstract:

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Associatio

APA, Harvard, Vancouver, ISO, and other styles

12

Patel, Preeti, Jitendra Kumar Badjatya, and Madhuri Hinge. "Comparative study of Regulatory requirements of Drug Product in Emerging market." International Journal of Drug Regulatory Affairs 7, no. 3 (2019): 48–62. http://dx.doi.org/10.22270/ijdra.v7i3.350.

Full text

Abstract:

Registration of Pharmaceutical drug product in Emerging Market is most demanding task. Regulatory requirements are harmonized in regulated countries by Common technical document (CTD) filing, while there is diversity of requirements in emerging markets. International conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has brought regulatory authorities and pharmaceutical industries of US, Japan and Europe together for various aspects of drug registration but there are is no such harmonized guideline for emerging market except Associatio

APA, Harvard, Vancouver, ISO, and other styles

13

Patel, Veer J., and Dasharath M. Patel. "A comprehensive review on registration requirements for Drug Approval in India, South Africa and US." International Journal of Drug Regulatory Affairs 9, no. 1 (2021): 62–71. http://dx.doi.org/10.22270/ijdra.v9i1.456.

Full text

Abstract:

The drug approval process is country-specific. The regulatory framework of all the national regulatory agencies differ from one another in terms of administration and product specific guidelines for registration of drug and drug products in a particular country. Every national regulatory authority provides regulatory guidelines for drug or drug product registration and the pharmaceutical industries which rely upon these guidelines prepare drug applications along with all the required administrative, non-clinical and clinical data in the form of a technical dossier which is known as Common Tech

APA, Harvard, Vancouver, ISO, and other styles

14

Velts, N. Yu, E. O. Zhuravleva, G. V. Kutekhova, and N. V. Tereshkina. "Submission of Documents on the Pharmacovigilance System as Part of the Registration Dossier within the Framework of the EAEU Procedures: Analysis of Requirements and Typical Errors." Safety and Risk of Pharmacotherapy 12, no. 3 (2024): 331–40. http://dx.doi.org/10.30895/2312-7821-2024-12-3-331-340.

Full text

Abstract:

INTRODUCTION. Documents on the pharmacovigilance system of the marketing authorisation holder (MAH), including the Pharmacovigilance System Master File (PSMF) and the PSMF-based summary of the pharmacovigilance system (SPS), are a mandatory component of the registration dossier for a medicinal product. Applicants must submit and update these documents in strict accordance with the legislation of the Eurasian Economic Union (EAEU). Systematisation of the requirements for drafting and submitting documents on the pharmacovigilance system will help applicants streamline the documentation process.A

APA, Harvard, Vancouver, ISO, and other styles

15

Hase, Sakshi R., Roshani G. Zaware, and Akash K. Shelke. "Overview of the Common Technical Documents." International Journal of Pharmaceutical Research and Applications 10, no. 1 (2025): 448–51. https://doi.org/10.35629/4494-1001448451.

Full text

Abstract:

"This article addresses the information needed to compile dossiers for different countries and the CTD format, which is anticipated to drastically cut down on the time and resources needed by the industry to create reports and applications for worldwide registration. The Common Technical Document (CTD) was created to provide a standard format for technical documentation submitted with an application for the registration of a pharmaceutical product for human use across Europe, the United States, and various Asian countries. The CTD dossier consists of five primary modules: Prescription and admi

APA, Harvard, Vancouver, ISO, and other styles

16

Subaev, R. D., G. N. Engalycheva, and D. V. Goryachev. "Justification of Safety of Homeopathic Medicines in a Registration Dossier." Safety and Risk of Pharmacotherapy 7, no. 4 (2019): 200–215. http://dx.doi.org/10.30895/2312-7821-2019-7-4-200-215.

Full text

Abstract:

Regulatory approaches to assessing the safety of homeopathic medicines in the Russian Federation and abroad are formed in accordance with regulatory acts, national and international rules and guidelines. Scientific literature is particularly important for justification of safety of homeopathic medicines. The purpose of this study was to determine the requirements and procedure for presenting justification of homeopathic medicines safety in the registration dossier in accordance with the documents of the Eurasian Economic Union and the European Union. According to the current Russian and foreig

APA, Harvard, Vancouver, ISO, and other styles

17

Yadav, Sudhir. "Building regulatory capabilities for pharmaceutical firms' internationalization." International Journal of Pharmaceutical and Healthcare Marketing 7, no. 1 (2013): 58–74. http://dx.doi.org/10.1108/1750612131131.

Full text

Abstract:

PurposeThe internationalization of pharmaceutical firms faces major barriers in terms of managing regulatory requirements in various international markets. This paper aims to identify the requirements related to regulations in various markets of the world. It further seeks to identify how the firms develop such capabilities i.e. processes undertaken by the firms to develop regulatory capabilities.Design/methodology/approachThe research is exploratory in nature. Case study method is adopted to study the requirements related to regulations in international markets and processes to build regulato

APA, Harvard, Vancouver, ISO, and other styles

18

Raysing, Swati, Pankaj Nerkar, Siddhesh Sanghavi, Shewta Jogdand, and Atul Patil. "Comparative study of Regulatory requirement for preparation of Dossier for Registration of Veterinary Drug in US, EU and Canada." International Journal of Drug Regulatory Affairs 11, no. 3 (2023): 62–67. http://dx.doi.org/10.22270/ijdra.v11i3.619.

Full text

Abstract:

The main purpose of this article is to research the requirement of the veterinary drug dossier submission in the three countries is US, EU, and Canada and the procedure of all the three countries are different for the submission of the veterinary drug dossier and their rules and regulation are different but all the three countries follow the VICH guidelines in these articles all the information available like necessary documents timeline approval procedure are different for US, EU, and Canada.

APA, Harvard, Vancouver, ISO, and other styles

19

Rutanshi, Patel*1 Gargi Patel2 Dr. Maitreyi N. Zaveri3 Zuki Patel4. "Strategic Insights into Drug Regulatory Affairs: Dossier Preparation, Marketing Authorization, Variation and Safety Monitoring in Tanzania." International Journal of Scientific Research and Technology 3, no. 4 (2025): 430–36. https://doi.org/10.5281/zenodo.15132665.

Full text

Abstract:

Pharmaceutical regulatory affairs play a crucial role in ensuring drug quality, safety, and efficacy. This thesis, titled "Strategic Insights into Drug Regulatory Affairs: Dossier Preparation, Marketing Authorization, Variation, and Safety Monitoring in Tanzania", explores the regulatory landscape of the Tanzania Medicines and Medical Devices Authority (TMDA). It provides a comprehensive analysis of dossier preparation for drug registration, the marketing authorization process, post-approval variation management, and pharmacovigilance requirements in Tanzania.The study examines TMDA’s re

APA, Harvard, Vancouver, ISO, and other styles

20

Cabezas, María Dolores. "The administrative information of the registration of a medicinal product dossier." Pharmaceuticals, Policy and Law 17, no. 1,2 (2015): 35–48. http://dx.doi.org/10.3233/ppl-140399.

Full text

APA, Harvard, Vancouver, ISO, and other styles

21

Ramsay, Alastair G. "Working Group 1: The Active Constituent—a Model International Registration Dossier." Drug Information Journal 23, no. 3 (1989): 515–28. http://dx.doi.org/10.1177/009286158902300329.

Full text

APA, Harvard, Vancouver, ISO, and other styles

22

Foteeva, A. V., N. A. Koneva, and N. B. Rostova. "On the Issue of the Effectiveness of the Department for Registration of Medicines." Drug development & registration 11, no. 4 (2022): 133–38. http://dx.doi.org/10.33380/2305-2066-2022-11-4(1)-133-138.

Full text

Abstract:

Introduction. New requirements for the registration of generic drugs after the entry of the Russian Federation into the Eurasian Economic Union (EAEU) and the signing of the Agreement on Common Principles and Rules for the Circulation of Medicinal Products identified a number of problems and opportunities that specialists in drug registration and working with regulatory authorities. The presented prospects for drug registration predetermine the list of tasks for the reorganization of the work of the department for work with regulatory authorities and the need to improve the competence of the e

APA, Harvard, Vancouver, ISO, and other styles

23

Prakruti, Patel*1 Rahul Nayak2 Dr. Maitreyi Zaveri3 Dr. Vinit Movaliya4. "Drug Registration Requirement Process for Kenya and Saudi Arabia." International Journal of Pharmaceutical Sciences 3, no. 4 (2025): 639–61. https://doi.org/10.5281/zenodo.15152956.

Full text

Abstract:

The pharmaceutical regulatory frameworks in Kenya and Saudi Arabia ensure drug safety, efficacy, and quality. Understanding their registration processes is crucial for pharmaceutical companies seeking market entry. This study compares the drug registration requirements of both countries, focusing on regulatory authorities, dossier submission, approval timelines, and key challenges. A comprehensive review of regulatory guidelines from the Pharmacy and Poisons Board (PPB) of Kenya and the Saudi Food and Drug Authority (SFDA) was conducted. Although both countries align with ICH and WHO standards

APA, Harvard, Vancouver, ISO, and other styles

24

Tesarivska, U. I., L. I. Fliak, and I. A. Holub. "STAGES OF EXPERTISE OF EXTERNAL APPEARANCE OF VETERINARY PRODUCTS." Scientific and Technical Bulletin оf State Scientific Research Control Institute of Veterinary Medical Products and Fodder Additives аnd Institute of Animal Biology 22, no. 1 (2021): 216–21. http://dx.doi.org/10.36359/scivp.2021-22-1.26.

Full text

Abstract:

The long moratorium on state control (supervision) over the activities of business entities has led to an increase in the volume of unregistered, low-quality, counterfeit and counterfeit veterinary products on the Ukrainian market. Violations by manufacturers regarding the entry into circulation of dangerous products are also due to the long absence of licensing of production and sale of products for veterinary medicine and animal husbandry. In these circumstances, there are numerous complaints from consumers about the low quality and safety of veterinary drugs, feeds, feed additives and premi

APA, Harvard, Vancouver, ISO, and other styles

25

Lee-Winter, Fiza, and Tonny Kirabira. "Dossier: The Stateless Rohingya—Practical Consequences of Expulsion." Genocide Studies and Prevention 15, no. 2 (2021): 3–9. http://dx.doi.org/10.5038/1911-9933.15.2.1863.

Full text

Abstract:

The international community has been called upon to ramp up efforts to end statelessness and provided with a guiding framework of 10 Actions. This dossier presents the practical consequences of expulsion, both direct and indirect outcomes of collective violence, directed towards the Rohingyas. Touching upon the nexus between children's rights, human trafficking, and practical challenges associated on-the-ground, the dossier also discusses the imperative need for the Association of Southeast Asian Nations (ASEAN) states—collectively as a region—to take steps in fulfilling Action 7 of the Global

APA, Harvard, Vancouver, ISO, and other styles

26

McKenna, Kevin. "Working Group 2: The Final Dosage Form—a Model International Registration Dossier." Drug Information Journal 23, no. 3 (1989): 529–38. http://dx.doi.org/10.1177/009286158902300330.

Full text

APA, Harvard, Vancouver, ISO, and other styles

27

Randeria, Juhi Ashwinbhai, Ronak Dedania, Zarna Dedania, Vineet Jain, and Meghna Danej. "Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review." International Journal of Drug Regulatory Affairs 6, no. 2 (2018): 14–21. http://dx.doi.org/10.22270/ijdra.v6i2.231.

Full text

Abstract:

Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product Afri

APA, Harvard, Vancouver, ISO, and other styles

28

Gupta, Rajkumar M. "PREPARATION & COMPILATION OF ACTD DOSSIER (PART II QUALITY)." International Journal of Drug Regulatory Affairs 3, no. 2 (2018): 17–21. http://dx.doi.org/10.22270/ijdra.v3i2.164.

Full text

Abstract:

ACTD is a critical document for drug substance and produces registration in ASEAN region. The document is essentially divided into 4 parts. Each part provides information under specific head. Out of all the parts, the part II is most important. This part not only evaluates technical suitability of the product but also determines the suitability of active drug and Excipients. The major stress in this part is on formulation, manufacturing, stability and process validation. The information required under this part is suitably detailed in this article.

APA, Harvard, Vancouver, ISO, and other styles

29

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.

Full text

Abstract:

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

APA, Harvard, Vancouver, ISO, and other styles

30

Badjatya, Jitendra Kumar, and Ramesh Bodla. "DRUG PRODUCT REGISTRATION IN SEMI-REGULATED MARKET." International Journal of Drug Regulatory Affairs 1, no. 2 (2018): 1–6. http://dx.doi.org/10.22270/ijdra.v1i2.3.

Full text

Abstract:

There found a diversity of regulatory requirement in Semi regulated market. This region consists of mainly thecountries from Asia pacific, Latin America, Eastern Europe, Africa and Gulf countries. Countries from Asia pacificand Gulf have somewhat harmonized their regulatory environment through The Association of Southeast AsianNations (ASEAN) and Gulf Co-operation Council (GCC) organizations, ROW countries yet to be harmonizedregulations in their respective regions.The urgent requirement to rationalize & harmonize regulation was required by instance of rising cost of health care,research &

APA, Harvard, Vancouver, ISO, and other styles

31

Wasiullah, Prof (Dr ). Mohd, Prof (Dr )Piyush Yadav, Sushil Yadav, Prakrity Maurya Prakrity Maurya, and Sakshi Singh Sakshi Singh. "A Review Article on the Common Technical Document (CTD) Regulatory Dossier." International Journal of Pharmaceutical Research and Applications 10, no. 2 (2025): 2777–82. https://doi.org/10.35629/4494-100227772782.

Full text

Abstract:

The Common Technical Document (CTD) represents a significant advancement in the harmonization of regulatory requirements for the registration of pharmaceutical products. Developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the CTD serves as a standardized dossier format for the submission of data to regulatory authorities in multiple regions, including the United States, European Union, and Japan. This review article provides a comprehensive overview of the CTD, its historical development, structural components, and global

APA, Harvard, Vancouver, ISO, and other styles

32

Aleksandrov, A. V. "EAEU registration dossier for a medicinal products in opinion of quality control specialist." Laboratory and production 14, no. 5 (2020): 30–40. http://dx.doi.org/10.32757/2619-0923.2020.5.14.30.40.

Full text

APA, Harvard, Vancouver, ISO, and other styles

33

Patel, Ravish, Amit Patel, and Tejasvini Gohil. "Regulatory requirement for the approval of Generic Drug in Cambodia as per ASEAN Common Technical Dossier (ACTD)." International Journal of Drug Regulatory Affairs 6, no. 2 (2018): 67–71. http://dx.doi.org/10.22270/ijdra.v6i2.245.

Full text

Abstract:

Drug approval process differs from one country to another country. In some countries only single body regulates the drug as well as responsible for all regulatory work which is a challenging task for the pharmaceutical companies to prepare single dossier that can be simultaneously submitted in many countries for approval. In all countries there is a similar characteristic in regulatory environment but there is a difference in their registration requirements. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Malaysia. T

APA, Harvard, Vancouver, ISO, and other styles

34

Hennebert, Pierre. "HAZARDOUS PROPERTIES OF BROMINATED, PHOSPHORUS, CHLORINATED, NITROGEN AND MINERAL FLAME RETARDANTS IN PLASTICS WHICH MAY HINDER THEIR RECYCLING." Detritus, no. 17 (December 16, 2021): 49–57. http://dx.doi.org/10.31025/2611-4135/2021.15142.

Full text

Abstract:

Flame retardants are numerous and some of them are (re)classified with time as hazardous for the man and the environment. A list of 69 flame retardants used in EU was set from three sources and their chemical properties were searched in their registration dossier at ECHA. Substance self-classifications (hazard statement assignment by the registrant) frequently indicate no hazard or data not available, while for the same substances a re-evaluation by ECHA is underway as persistent, bioaccumulative, toxic or endocrine disruptor. When the substance has hazard statement(s), the concentration that

APA, Harvard, Vancouver, ISO, and other styles

35

Lovkova, A. O., S. M. Gyulakhmedova, A. A. Druzhinina, and A. A. Nekipelova. "Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers." Safety and Risk of Pharmacotherapy 11, no. 4 (2023): 463–72. http://dx.doi.org/10.30895/2312-7821-2023-11-4-463-472.

Full text

Abstract:

Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance documents, particularly the risk management plan (RMP). In practice, the changed EAEU GVP has resulted in multiple errors, creating the need to thoroughly analyse their structure and causes and to develop recommendations for their prevention.Aim. This study aimed to identify, analyse, and collate inconsistencies between the information submitted by marketi

APA, Harvard, Vancouver, ISO, and other styles

36

Niyazov, R. R., D. A. Rozhdestvenskiy, D. V. Goryachev, et al. "Issues of bringing the registration dossier in compliance with the requirements of the Rules for Registration and Expertise in EAEU." Remedium Journal about the Russian market of medicines and medical equipment, no. 5 (2019): 8–20. http://dx.doi.org/10.21518/1561-5936-2019-5-8-20.

Full text

APA, Harvard, Vancouver, ISO, and other styles

37

Nam, Pham Phuong. "Factors Influencing the Residential Land Use Right Mortgage in Yen My District, Hung Yen Province, Vietnam." International Journal of Service Science, Management, Engineering, and Technology 13, no. 1 (2022): 1–18. http://dx.doi.org/10.4018/ijssmet.290337.

Full text

Abstract:

The study aims to identify influencing factors and their influences on the residential land use right mortgage as the basis for proposing solutions to improve land use right mortgage. The study used methods of collecting secondary and primary data; processing and analyzing data using SPSS20.0 software. There were 5268 cases of land use right mortgage registration, 3240 cases of land use right mortgage removal and 924 cases for changing contents of land registration. The study identified 7 factor groups with 27 factors affecting land use right mortgage. The credit factor group has the biggest i

APA, Harvard, Vancouver, ISO, and other styles

38

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.

Full text

Abstract:

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

APA, Harvard, Vancouver, ISO, and other styles

39

Meshkovskii, A. P., N. V. Pyatigorskaya, V. V. Beregovykh, et al. "CHANGE MANAGEMENT OF DRUG PRODUCTS REGISTRATION CONDITIONS: NEW ICH Q12 GUIDELINE." Annals of the Russian academy of medical sciences 73, no. 3 (2018): 181–89. http://dx.doi.org/10.15690/vramn998.

Full text

Abstract:

Introduction of amendments to the registration dossier is the responsibility of the marketing application holder (MAH). Increased knowledge on pharmaceuticals, its manufacturing and control processes can reduce the number of documents submitted to the regulatory authorities. The existing requirements establishing the procedure for the introduction of amendments differ in terms of change classification, period of notification of regulatory authorities, ways of conformity validation of pharmaceutical properties, etc. ICH proposed draft guideline Q12 «Technical and Regulatory Considerations for P

APA, Harvard, Vancouver, ISO, and other styles

40

Nerkar, Pankaj, Atul P. Patil, Mayuri V. Ahire, Suhas R. Mahajan, and Swati D. Raysing. "Drug Product and Drug Substance (CADIFA) Registration process in Brazil." International Journal of Drug Regulatory Affairs 11, no. 3 (2023): 11–21. http://dx.doi.org/10.22270/ijdra.v11i3.607.

Full text

Abstract:

There is a significant demand for improved healthcare and advanced pharmaceuticals in Brazil, presenting lucrative opportunities for foreign investors. However, engaging in business activities in Brazil can be challenging due to various factors. The process of registering pharmaceutical products in the country is time-consuming. Moreover, the highly regulated, complex, and fragmented Brazilian healthcare system, which is prone to corruption, can pose significant difficulties for small and medium-sized enterprises lacking the necessary financial resources and market knowledge. To comply with re

APA, Harvard, Vancouver, ISO, and other styles

41

Engalycheva, G. N., and R. D. Syubaev. "Preparation of a Nonclinical Overview Based on Scientific Literature." Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 11, no. 4 (2021): 263–72. http://dx.doi.org/10.30895/1991-2919-2021-11-4-263-272.

Full text

Abstract:

Current requirements for the registration dossier include submission of a preclinical (nonclinical) overview, including scientific literature data on preclinical studies and actual preclinical data on the medicinal product. For some groups of medicines, scientific literature data may be used instead of actual preclinical data, which may be redundant. One of the important functions of the scientific literature review is the analysis of updated preclinical information on the medicinal product, which reflects the product’s characteristics, supports conclusions on its efficacy or safety, and may a

APA, Harvard, Vancouver, ISO, and other styles

42

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.

Full text

Abstract:

<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

APA, Harvard, Vancouver, ISO, and other styles

43

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.

Full text

Abstract:

<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

APA, Harvard, Vancouver, ISO, and other styles

44

Hennebert, Pierre. "THE SUBSTITUTION OF REGULATED BROMINATED FLAME RETARDANTS IN PLASTIC PRODUCTS AND WASTE AND THE DECLARED PROPERTIES OF THE SUBSTITUTES IN REACH." Detritus, no. 16 (September 30, 2021): 16–25. http://dx.doi.org/10.31025/2611-4135/2021.15122.

Full text

Abstract:

Plastics containing brominated flame retardants (BFR) currently contain both “legacy” regulated and non-regulated BFR (R-BFRs and NR-BFRs), as evidenced by the increasingly lower correspondence over time between total bromine and R-BFRs content. The portion of substitutive NR-BFR present in the plastics and their toxicity and ecotoxicity properties are documented. Data relating to plastics and foam present in electrical and electronic equipment (EEE), waste EEE, vehicles, textiles and upholstery, toys, leisure and sports equipment show how 88% of plastic waste contains bromine from NR-BFRs. BF

APA, Harvard, Vancouver, ISO, and other styles

45

Koshechkin, K. A., E. M. Rychikhina, and Yu V. Olefir. "Digital systems to generate an electronic dossier and support the procedure for registration of medicinal products." Remedium Journal about the Russian market of medicines and medical equipment, no. 10 (2018): 37–41. http://dx.doi.org/10.21518/1561-5936-2018-10-37-41.

Full text

APA, Harvard, Vancouver, ISO, and other styles

46

Ustinnikova, O. B., I. A. Alekseeva, M. V. Abramtseva, T. I. Nemirovskaya, and A. A. Movsesyants. "Polysaccharide Vaccines. Current Approaches to Quality Assessment Issues." Epidemiology and Vaccinal Prevention 19, no. 5 (2020): 104–11. http://dx.doi.org/10.31631/2073-3046-2020-19-5-104-111.

Full text

Abstract:

Relevance. Polysaccharide vaccine quality assessment must, on the one hand, comply with modern domestic and international regulatory documents, and on the other hand, reflect the characteristics of newly developed drugs. The list of drugs registered on the Russian market is constantly expanding due to the development of new effective vaccines and the introduction of new production sites. Thus, the expert requirements for assessing the quality of these drugs and the information content of the documents submitted as part of the registration dossier need to be updated.Aims. The aim is to update t

APA, Harvard, Vancouver, ISO, and other styles

47

Donee, Garg, and Sharma Nitin. "Regulatory pathway for pharmaceutical drug product registration and export in Gulf countries." Pharmaspire 15, no. 04 (2023): 236–42. http://dx.doi.org/10.56933/pharmaspire.2023.15136.

Full text

Abstract:

The Indian pharmaceutical market is the third largest in terms of generic production. It has developed a reputation as a center of industry and research in the international market. India offers some of the costeffective manufacturing facilities globally. The Gulf cooperation council (GCC) region is regarded as a “developing market for pharmaceutical export”. This study assessed the regulatory frameworks of the GCC member countries of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates (UAE) to build a coordinated approach. GCC regions are exposed to a partially regulated

APA, Harvard, Vancouver, ISO, and other styles

48

Panchal, Vruddhi, Utsav Patel, Vinit Movaliya, Khushboo Vaghela, Niranjan Kanki, and Maitreyi Zaveri. "Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)." International Journal of Drug Regulatory Affairs 10, no. 3 (2022): 66–69. http://dx.doi.org/10.22270/ijdra.v10i3.532.

Full text

Abstract:

Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate proper knowledge regarding main critical issues, differences as well as similarities of related drug regulation. There is a different requirement for registration of generic product in each regulatory system but also comprises of some similar outline that includes some common rules. These are variances and regulatory hurdles such as Number of batches for submiss

APA, Harvard, Vancouver, ISO, and other styles

49

Chaplenko, Alexander, Geliya Gildeeva, and Vasiliy Vlassov. "The Entry Lag of Innovative Drugs in Russia, 2010–2019." International Journal of Environmental Research and Public Health 18, no. 10 (2021): 5052. http://dx.doi.org/10.3390/ijerph18105052.

Full text

Abstract:

Objective: Evaluation of the lag timelines for the launch of innovative drugs to the Russian market and pharmacoeconomic factors they can depend on. Methods: To complete the investigation, we used information about drug products, namely, dates of submission and approval, and pharmacological groups recovered from national registers and official databases. Results: Due to impacts of market factors and imperfection of the state regulation, original drugs developed abroad enter the Russian market a few years after their registration in the United States of America, the European Union, and Japan. T

APA, Harvard, Vancouver, ISO, and other styles

50

B., Naveen Kumar *. MV. Nagabhushanam Brahmaiah Bonthagarala D. Nagarjuna Reddy G. Ramakrishna. "COMPARISON OF REGULATORY REQUIREMENTS FOR GENERIC DRUGS DOSSIER IN UNITED STATES AND EUROPE." Journal of Pharma Research 8, no. 8 (2019): 613–18. https://doi.org/10.5281/zenodo.3382169.

Full text

Abstract:

<strong><em>ABSTRACT</em></strong> <strong><em>C</em></strong><em>ommon technical document (CTD) provides a standardized structure for regulatory submissions that is acceptable in all ICH countries. Although the CTD makes multinational filing 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. Generic drug in US they are approved under the abbreviated new drug application. Bio availability and bio equivalence study data is critical in the generic dru

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!