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Journal articles on the topic 'Drug Regulatory Authority'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

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1

S., D. Dhole* R. B. Darade. "Indian Pharmaceutical Regulatory Authority: Review." International Journal in Pharmaceutical Sciences 2, no. 5 (2024): 1109–19. https://doi.org/10.5281/zenodo.11235269.

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Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO is responsible for conducting Clinical trials for new drug and provide approval to the new drug. CDSCO also monitors the Rules and Regulation regarding various medicinal practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical trials.

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Jayasuriya, L. "The drug regulatory authority." Ceylon Medical Journal 45, no. 2 (2015): 87. http://dx.doi.org/10.4038/cmj.v45i2.8012.

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Abhishek, Deshmukh* Tejas Sharma Dr. Shivshankar Mhaske Krushna Tayade kasim Bhuriwale. "CDSCO: pharmaceutical regulatory authority of India." International Journal of Pharmaceutical Sciences 3, no. 2 (2025): 101–6. https://doi.org/10.5281/zenodo.14789469.

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Central Drug Standard Control Organization is Regulatory Authority in India. CDSCO Is responsible for conducting Clinical trials for new drug and provide approval to the New drug. CDSCO also monitors the Rules and Regulation regarding various medicinal Practices in India. Functions of CDSCO include ensuring the quality of drugs, Medical Devices and cosmetics sold in the country, approval of new drugs and regulating clinical Trials

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4

Adukondalu, D., Rajesh Rajesh, Shaik Thaslim, E. Soumya, and M. Chandana. "Regulatory Guidelines for New Drug Development." Pharmaceutics and Pharmacology Research 4, no. 3 (2021): 01–11. http://dx.doi.org/10.31579/2693-7247/046.

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Aim: The aim of present project work is to understand the guidelines and regulatory requirements for investigational new drug and development of new drug Objectives: The objective of current project include Need of a new drug to investigate New drug development targets Understanding the properties of new dug Required protocols for submission of new drug to regulatory authority Regulatory requirements to get approval of new drug.

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Kolte, Yash Raju. "Regulatory Authority in Pharmacovigilance." International Journal for Research in Applied Science and Engineering Technology 11, no. 12 (2023): 148–57. http://dx.doi.org/10.22214/ijraset.2023.57254.

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Abstract: Based on their Gross National Income (GNI) per capita, the World Bank has categorized 80 economies as HighIncome. Global pharmacovigilance rules are primarily driven by three major regulatory stakeholders: the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA). This article's goal is to provide an overview of pharmacovigilance systems and procedures in high-income nations, especially those that are also International Conference on Harmonization (ICH) members. Every high-income nation is a part of the WHO

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Bandarapalle, Kishore, Rajasekhar Komarla Kumarachari, Kamasani Teja Sri, et al. "A Review on regulatory affairs and regulatory requirements for drug approval." Future Journal of Pharmaceuticals and Health Sciences 4, no. 1 (2024): 26–38. http://dx.doi.org/10.26452/fjphs.v4i1.550.

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Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t

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Bandarapalle, Kishore. "A Review on regulatory affairs and regulatory requirements for drug approval." A Review on regulatory affairs and regulatory requirements for drug approval 4, no. 1 (2024): 26–38. https://doi.org/10.5281/zenodo.14650148.

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Regulatory affairs are a new profession that can be developed for the controlling the safety, quality and efficacy of the drug products by submitting the investigational new drug application (IND) and new drug application (NDA) to regulatory authority. The whole process may be done in conscious manner in order to release a safe drug product to protect the public from toxic effects of drugs during and after the usage of drugs. The main intention of this article was to aware the peoples towards the role of regulatory affairs department, requirements for new drug approval and the involvement of t

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Ashok, Kumar P., GM Renu, S. Gowda Suhas, HU Tejaswini, Kumar Vinay, and HN Yashwanth. "Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 404–9. https://doi.org/10.5281/zenodo.12186280.

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Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. 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 article focuses on history, regulatory policy and organization, and re

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9

Mann, R. D. "EEC SUPRANATIONAL DRUG REGULATORY AUTHORITY BY 1992?" Lancet 332, no. 8606 (1988): 324–26. http://dx.doi.org/10.1016/s0140-6736(88)92369-0.

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Rajendra, K. Songara, Yashwant, Singhal Manmohan, Gupta Vipul, and Promila. "Need for Hormonisation of Labelling of OTC drugs." International Journal of Current Pharmaceutical Review and Research 1, no. 1 (2010): 33–58. https://doi.org/10.5281/zenodo.12699623.

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Over the counter (OTC) drugs are medicine that may be sold without a prescriptionand without a visit to a medical professional in contrast to prescription drugs. Readingthe product label is the most important part of taking care of when using OTCmedicines. There is increasing need for consumer to have easily readable andunderstandable information about OTC drugs. Information on active ingredients,warnings, indications, storage conditions, contraindications, directions, purposes andother information, must be legible and accessible as OTC drug products are nowwidely available and used without me

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11

G., Raja Mohan Reddy, M. P. Venkatesh, Achin J., and Pramod Kumar T.M. "REGULATORY PERSPECTIVES OF PHARMACEUTICAL PRODUCTS IN GHANA." International Journal of Drug Regulatory Affairs 2, no. 2 (2018): 7–15. http://dx.doi.org/10.22270/ijdra.v2i2.126.

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Drug Registration is a procedure of expertise of pharmaceutical product quality, efficacy and safety by the Regulatory Authority. The emergence of various formats has enabled the manufacturers of the drug to easily gain access into various markets and thus was able to place their products into the market. The choice of Ghana as one of the destinations for the market of the Drug products ensures the manufacturer a good market value. Ghana is considered as one of the growing pharmaceutical market in east Africa. Of late, generic drugs are holding a major stake in the pharmaceutical market and ar

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Jain, Achin, M. P. Venkatesh M P, and Pramod T. M. Kumar. "DRUG REGULATORY PROCEDURES IN TANZANIA: A GLIMPSE." International Journal of Drug Regulatory Affairs 3, no. 2 (2015): 1–7. http://dx.doi.org/10.22270/ijdra.v3i2.12.

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In Tanzania, Tanzania Food and Drugs Authority (TFDA), is a regulatory body responsible for controlling the quality,safety and effectiveness of food, drugs, herbal drugs, cosmetics and medical devices. The Authority has been ensuringsafety, efficacy and quality of medicines by quality control tests; in addition to other quality assessment mechanisms.The guidelines laid by TFDA have also emanated from commitment to democracy and gives strong emphasis to thefulfilment of the needs of the less privileged rural population.Tanzania is an emerging market; the pharmaceutical market is valued at over

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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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Kumar, Mal Dipak, Samrat Chakraborty, and Biswajit Mukherjee. "FEEBLE REGULATORY AFFAIRS WEAKEN THE BACKBONE OF INDIAN DRUG INDUSTRIES." International Journal of Drug Regulatory Affairs 2, no. 4 (2018): 1–13. http://dx.doi.org/10.22270/ijdra.v2i4.10.

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India is emerging as a global outsourcing power house in almost all fields including Drugs and Pharmaceutical sector.Now it becomes a hub to conduct clinical trials and contract researches. Pharmaceutical industry currently opts fortotal quality management as primary criteria to prevent sub-standard products which do not fall under officialspecifications. However, there are many areas where immediate regulatory measures are desired. Central DrugsStandard Control organization (CDSCO) is the prime regulatory authority for the purpose of enforcement accordingto the Drugs and Cosmetic Act 1940 and

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Sanket, Sukhadev Arole, Dattu Navale Santosh, S. Hiwrale Rohit, and S. Tayade Gaurav. "A Review on New Drug Application (NDA) and General Consideration in Pharmaceutical Industry." American Journal of PharmTech Research 12, no. 3 (2022): 122–33. https://doi.org/10.5281/zenodo.7106642.

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ABSTRACT In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The components of any NDA are a function of the nature of the subject drug and the information available to the applicant at the time of submission. The form to use for either NDA or ANDA is Form FDA-356h, App

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Kishor, S. Arote* Darshan A. Salade Nilesh V. Patil. "A Brief Review on Regulatory Affairs: Ensuring Compliance, Safety, and Market Access." International Journal in Pharmaceutical Sciences 1, no. 10 (2023): 22–30. https://doi.org/10.5281/zenodo.8397986.

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This review paper provides a comprehensive analysis of the field of regulatory affairs, offering insights into its historical evolution, current challenges, emerging trends, and future directions. Regulatory affairs play a pivotal role across various industries in ensuring compliance with laws and regulations, maintaining product quality, and safeguarding public health and safety. Drug regulatory affairs are an important part of the pharmaceutical industry. As usual the pharmaceutical industry is growing very fast, and there is a need Regulatory affairs experts to meet current needs industry f

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Roohi, Bano Obaid, and Ali Obaid. "Emergence of Enhanced Quality Expectations in Pharmaceuticals." International Journal of Endorsing Health Science Research 6, no. 3 (2018): 01–05. https://doi.org/10.29052/IJEHSR.v6.i3.2018.01-05.

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Abstract Commercial viability of any drug product may often bring pain for patients who otherwise wait for their drug to improve their quality of life and breath. Dryness of drug products like thyroxin, warfarin, phenobarbitone, salbutamol inhalers, morphine etc. from the market leave patient on the mercy of nature. The heart wrenching healthcare professional burst out when lifesaving drugs are not available due to any reason. Voice of civil society rises in community where care of others is felt as a moral responsibility beside capitalism and/or socialism. It is also observed and quite possib

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Pankaj, Kumar* Bharti Mangla2 Satbir Singh Arapna Rana. "GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT." Indo American Journal of Pharmaceutical Sciences 04, no. 12 (2017): 4705–19. https://doi.org/10.5281/zenodo.1079864.

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Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original innovator drug manufacturer and adds only bioequivalence studies. Therefore it is very difficult

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Singh, Navyug Raj. "Positive Vibes from the Drug Regulatory Authority of India." Journal of Research in Medical Education & Ethics 3, no. 1 (2013): 3. http://dx.doi.org/10.5958/j.2231-6728.3.1.001.

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Ashok Kumar P, Renu GM, Suhas S Gowda, Tejaswini HU, Vinay Kumar, and Yashwanth HN. "Current regulatory requirements and regulation on submission of ANDA in India comparison with Singapore." World Journal of Advanced Research and Reviews 20, no. 1 (2023): 404–9. http://dx.doi.org/10.30574/wjarr.2023.20.1.2056.

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Developing a new drug requires great quantity of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the liability of evaluate whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. 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 article focuses on history, regulatory policy and organization, and re

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Prajapati, Vishal, Rahulgiri Goswami, Pratik Makvana, and Jitendra Kumar Badjatya. "A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA." International Journal of Drug Regulatory Affairs 2, no. 1 (2014): 1–11. http://dx.doi.org/10.22270/ijdra.v2i1.7.

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Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. 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 article focuses on drug approval process in different countr

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B. Shivasai, Shaik Zareena Begum, and S. Sunayana. "Comparative Study Of New Drug Application Procedure In Us, Eu And India." International Journal of Allied Medical Sciences and Clinical Research 12, no. 4 (2024): 585–95. https://doi.org/10.61096/ijamscr.v12.iss4.2024.585-595.

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Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. 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 article focuses on drug approval process in different countr

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Uma Maheshwari A and Kamaraj R. "Regulatory Approval process for marketing drug in Japan." International Journal of Research in Pharmaceutical Sciences 12, no. 2 (2021): 1081–85. http://dx.doi.org/10.26452/ijrps.v12i2.4636.

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For the development of new drug, it requires a greater amount of research work in chemistry, Manufacturing, control, Preclinical and clinical trials. The drug approval process in all regulatory market carrying responsibilities on multiple factors such as data, safety, efficacy to public health in a country. Current constrain of affairs reveals diverse countries need to follow different regulatory requirements for Regulatory approval process for marketing drug in the different regulatory market of the country to ensure safety and efficacy of the product. In order to conduct a regulatory process

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K.Sandhya, Y. Sirisha, K. Nagasree, and K. Chaitanya Prasad. "Global process for generic drug approval." International Journal of Allied Medical Sciences and Clinical Research 11, no. 4 (2023): 427–34. http://dx.doi.org/10.61096/ijamscr.v11.iss4.2023.427-434.

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Drug approval standards in the United States are considered by many to be the most demanding in the world. Developing a new drug requires great amount of research work in discovery, development, preclinical research, clinical research. Reviewers in regulatory agencies throughout the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate

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Ashok, Gorja*, Deepika Reddy Challa, Sucharitha Keerthi, and Tanmai Samperveni. "INSIGHTS OF REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY – A REVIEW." World Journal of Pharmaceutical Science and Research 3, no. 2 (2024): 161–83. https://doi.org/10.5281/zenodo.10946321.

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Regulatory affairs (RA) plays a vital role in the pharmaceutical industrial department which has the responsibility for obtaining approval for new products arriving in the market and ensuring that approval is maintained for as long as the company wants to keep the product for marketing & it also provides calculated and operational ways and assist for working within regulations to accelerate the development and delivery of safe and effective healthcare products for every particular person all over the world. It behaves as the link between the regulatory authority and the project team and is

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Chang, Clare. "Briefing documents: Facilitating health authority interactions." Medical Writing 34, no. 2 (2025): 112–15. https://doi.org/10.56012/ucdt2648.

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Briefing documents, essential for facilitating interactions between pharmaceutical companies and health authorities like the US FDA and EMA, provide critical information necessary for obtaining scientific advice throughout drug development. These documents encompass product background, development status, regulatory interactions, and specific questions from Sponsors, significantly influencing regulatory decision-making. The complexity of briefing documents varies based on development stages, requiring detailed preparation by medical writers to ensure clarity and relevance. Successful interacti

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Gogna, Kunal. "Regulatory aspects of Impurity profiling." International Journal of Drug Regulatory Affairs 8, no. 4 (2020): 45–54. http://dx.doi.org/10.22270/ijdra.v8i4.433.

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Quality, safety and efficacy of pharmaceuticals play an important role in drug therapy. The safety attribute of drug is established by its pharmacological or toxicological profile along with adverse effects caused by impurities in bulk and dosage form. Impurities present in drug often possess undesired pharmacological or toxicological effects which outweighs the benefits of drug therapy. Recently, many impurity cases have been reported for e.g. NDMA (N-nitroso dimethylamine) impurity in drug product Ranitidine. This may be due to inappropriate follow of impurity related regulatory guidelines o

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Kashyap, Pankaj, Eshant Duggal, Vikaas Budhwaar, Dr Arun Nanda, and Jitendra Kumar Badjatya. "DRUG APPROVAL PROCESS: A CONTRASTIVE APPROACH." International Journal of Drug Regulatory Affairs 1, no. 2 (2018): 11–19. http://dx.doi.org/10.22270/ijdra.v1i2.107.

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The drug approval process is the vehicle through which drug sponsors formally approve a new pharmaceutical for sale and marketing. The goals of the approval process are to provide enough information about the drug safety and efficacy in human beings. 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. The approval process starts with preclinical testing. For drugs that appear safe, an investigational new drug application (IND) is filed. If approved, clinical trials begin with

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Gouveia, William A., and Edward L. Decker. "Regulatory Authority Affecting American Drug Trials: Role of the Hospital Pharmacist." Drug Information Journal 27, no. 1 (1993): 129–34. http://dx.doi.org/10.1177/009286159302700124.

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Warner, Jeremy Lyle, Sanjay Mishra, Matthew James Hadfield, et al. "Who goes first? Patterns of cancer drug approvals across four major regulatory authorities: EMA, FDA, Health Canada, and PMDA." JCO Oncology Practice 19, no. 11_suppl (2023): 149. http://dx.doi.org/10.1200/op.2023.19.11_suppl.149.

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149 Background: New anticancer therapies have led to substantial improvements in prognosis across many cancers. Commercial access to a drug is not possible until the drug has received regional regulatory authority market authorization. In prior work (1), we found that European Medicines Agency (EMA) drug approvals frequently lagged US Food and Drug Administration (FDA) approvals from 2010-2019. Here, we expand the analytic time period to 2004-2023 and include two additional regulatory agencies – Health Canada (HC) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). Methods: Drugs wi

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Shaik, Azeem S.B.Puranik. "Regulatory Harmonisation In South Africa: A Critical Overview." Journal of Pharma Research 9, no. 6 (2020): 10. https://doi.org/10.5281/zenodo.3923724.

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ABSTRACT The purpose of this article is to present a concise overview of changes in variation of South African Health Products Regulatory Authority (SAHPRA) and its adoption of variation policies from European Medicines Agency (EMA). Along with which we have also discussed about the exclusions, additions of variation guidelines in different aspects. In this article, along with variation changes by SAHPRA, it also includes about different reliance pathways adopted and also about difference in document and data requirements by the authority for reliance based evaluations and principles involved

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Fernandez Lynch, Holly, Rachel E. Sachs, Sejin Lee, Matthew Herder, Joseph S. Ross, and Reshma Ramachandran. "Extending the US Food and Drug Administration’s Postmarket Authorities." JAMA Health Forum 4, no. 6 (2023): e231313. http://dx.doi.org/10.1001/jamahealthforum.2023.1313.

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ImportanceThe US Food and Drug Administration (FDA) has expansive regulatory flexibility regarding the quality and quantity of evidence it deems sufficient to approve new drugs, which has been increasingly used to grant approval based on less certain evidence of benefit. However, the FDA’s regulatory flexibility with respect to standards for approval has not been matched by sufficient stringency in its exercise of postmarket safeguards, including the FDA’s authority and willingness to require confirmation of benefit through postmarket efficacy studies or to withdraw approval when benefit is no

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Nadipineni, Ashok Kumar, Dileep K. G., Ravindra C. K., and Suthakaran R. "AN OVERVIEW OF CHINESE DRUG REGULATORY SYSTEM: A REVIEW." International Journal of Drug Regulatory Affairs 2, no. 3 (2018): 14–18. http://dx.doi.org/10.22270/ijdra.v2i3.137.

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The Drug regulatory authority of China was renewed from state pharmaceutical administration of China (SPAC) to state food and Drug administration (SFDA) with the announcement and declaration of Chinese ministry of health, the established regulatory standards of SFDA were keen to keep with international standards of EU, Japan and USA, the Drug registrations and Drug approvals are carried with established affiliated units for fast track evaluation within prescribed period ordered by SFDA, the state food and Drug administration is developed stringently and modified its standards according to the

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Wood, Susan M. "Postmarketing Surveillance: Viewpoint from a Regulatory Authority." Drug Information Journal 25, no. 2 (1991): 191–95. http://dx.doi.org/10.1177/009286159102500207.

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Price, Polly J. "Public Health Control Measures in Response to Global Pandemics and Drug Resistance." Journal of Law, Medicine & Ethics 43, S2 (2015): 49–56. http://dx.doi.org/10.1111/jlme.12266.

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These teaching materials explore the specific powers of governments to implement control measures in response to communicable disease, in two different contexts:The first context concerns global pandemic diseases. Relevant legal authority includes international law, World Health Organization governance and the International Health Regulations, and regulatory authority of nations.The second context is centered on U.S. law and concerns control measures for drug-resistant disease, using tuberculosis as an example. In both contexts, international and domestic, the point is to understand legal auth

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Baylor, Norman W. "Role of the national regulatory authority for vaccines." International Journal of Health Governance 22, no. 3 (2017): 128–37. http://dx.doi.org/10.1108/ijhg-04-2017-0017.

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Purpose Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue. Design/methodology/approach Expert review. Findings Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. How

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Szentiványi, Mátyás. "Future of the Hungarian Drug Market : Role of the Hungarian Regulatory Authority." Acta Pharmaceutica Hungarica 91, no. 3-4 (2021): 131–32. http://dx.doi.org/10.33892/aph.2021.91.131-132.

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Tominaga, Toshiyoshi, Yuki Ando, and Tatsuya Kondo. "International Vision and Strategy for Drug Regulatory Authority: The PMDA's International Vision." Clinical Pharmacology & Therapeutics 92, no. 3 (2012): 349–51. http://dx.doi.org/10.1038/clpt.2012.90.

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Krunal, G. Kanjariya* Maitreyi Zaveri Vinit Movaliya. "A Comparative Study Medical Device Dossier Of UGANDA And USA." International Journal in Pharmaceutical Sciences 2, no. 7 (2024): 1989–98. https://doi.org/10.5281/zenodo.13110193.

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This study provides a comprehensive comparison of the medical device dossier requirements in Uganda and the United States, highlighting the regulatory frameworks, submission processes, and compliance standards. By examining the regulatory agencies—the Uganda National Drug Authority (NDA) and the U.S. Food and Drug Administration (FDA)—the research identifies key differences and similarities in their approaches to medical device approval. The study delves into the classification systems, dossier content requirements, and review timelines, emphasizing how these factors impact market

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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.

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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

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SO, Nasare. "Procedures for Dossier Preparation and their Marketing Authorisation in Zimbabwe Country for Complementary Drug." Pharmaceutical Drug Regulatory Affairs Journal 6, no. 1 (2023): 1–4. http://dx.doi.org/10.23880/pdraj-16000141.

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The Medicines Control Authority of Zimbabwe (MCAZ) is the authority to regulate from the Ministry of Health. It is established through an Act of Parliament which gives these bodies the `power to regulate the quality and sale of Complementary medicines. The objectives of this study were to evaluate the current regulatory review process of the Medicines Control Authority of Zimbabwe (MCAZ), identify key milestones and target timelines, evaluate overall performance from 2017 to 2019, identify best practices in review, evaluate the quality of decision-making processes and identify challenges and o

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Rohit, VVSS, Prakash Veluchuri Jaya, Adhikari Sravya, and Indukuri Harika. "An Overview on Pharmaceutical Drug Recalls." Pharmaceutical and Chemical Journal 7, no. 1 (2020): 16–22. https://doi.org/10.5281/zenodo.13951394.

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Every year drug recalls occurs routinely. The product recall is resorted to if there is evidence that the use and the continued presence of a batch of a product on the market presents a risk to the health of the user or a local regulatory authority directs a recall. A company must, therefore, have a system for speedy and efficient removal of unsatisfactory material from the market. There should be a written procedure that must define-who is responsible for deciding to initiate a recall and how the product, including samples, can be traced and removed from the market. Product recall not only ef

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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.

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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

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Jain, Achin, Venkatesh M. P., Raja Mohan Reddy.G, and Pramod Kumar T.M. "REGULATORY REQUIREMENTS & MARKETING AUTHORIZATION OF GENERIC DRUGS IN SINGAPORE & THAILAND." International Journal of Drug Regulatory Affairs 3, no. 1 (2018): 62–74. http://dx.doi.org/10.22270/ijdra.v3i1.158.

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The availability of generic medication is an important issue in the ASEAN region. The regulatory requirements of various countries vary from each other. Therefore, it is challenge for the companies to get drug approved for marketing simultaneously in different countries. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of medicines in their country. It not only includes the process of regulating and monitoring the drugs, but also the process of manufacturing, distribution, and promotion. The regulatory environment has similar characteristics, but drug regis

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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.

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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

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Pomeranz, Jennifer L. "A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels." American Journal of Law & Medicine 39, no. 4 (2013): 617–47. http://dx.doi.org/10.1177/009885881303900403.

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The modern food environment is considered a primary driver of obesity and other nutrition-related chronic diseases. A significant contribution to this environment is the proliferation of claims on food packaging that provides a misleading picture of a product's healthfulness. The Food and Drug Administration (FDA) is the agency responsible for food labels but it lacks the regulatory authority and adequate resources to address the majority of questionable labeling practices. The FDA's current system of enforcement is thus essentially based on voluntary compliance and consumer- and manufacturer-

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Tatti, P. "The Rise and Fall of Rosiglitazone." Clinical Medicine. Therapeutics 1 (January 2009): CMT.S2368. http://dx.doi.org/10.4137/cmt.s2368.

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Rosiglitazone is a member of the Thiazolidinedione class of drugs with a potent insulin sensitizing action. The drug has been extensively used and many early warnings on its potential risks were ignored mostly due to an aggressive commercial strategy. In 2007 some papers raised doubts on the cardiovascular safety of the drug and started a serious dispute. Irrespective of the real existence of this risk the story of Rosiglitazone led to the unveiling of many other side effects and emphasizes the need for a more accurate evaluation of any drug before is approved by the regulatory authority.

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Ansh, Patel1* Dr. Niranjan Kanaki2 Shruti Kharidia3 Dr. Maitreyi Zaveri4. "Regulatory Requirements of Bioequivalence Study for Tanzania, Philippines and Costarica." International Journal of Pharmaceutical Sciences 3, no. 3 (2025): 3142–54. https://doi.org/10.5281/zenodo.15109010.

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Bioequivalence tests are necessary to ensure that generic pharmaceuticals are equivalent to branded treatments. This comparison emphasizes the bioequivalence criteria in Tanzania, the Philippines, and Costa Rica, pointing out significant variances. In Tanzania, the Tanzania Medicines and Medical Devices Authority (TMDA) mandates bioequivalence studies for generic pharmaceuticals, which must adhere to international standards such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), typically in conjunction with local clinical trials. In the Philippines, the Food and Drug Administ

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Patil, Aditya Dilipkumar. "Revamping homoeopathy from Drug and Cosmetic Act of 1940 to New Drugs, Medical Devices and Cosmetics Bill, 2022; A perspective. of 1." International Journal of High Dilution Research - ISSN 1982-6206 21, cf (2023): 85–88. http://dx.doi.org/10.51910/ijhdr.v21icf.1254.

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Government of India at its 72nd year of republic had drafted the new bill entitled “New Drugs, Medical Devices and Cosmetics Bill 2022” which seeks to replace the existing “Drugs and Cosmetics Act, 1940”. Earlier in this Act, Chapter V mentions the support of regulatory authority for Ayurveda, Siddha, Unani drug. However the new draft of bill includes Sowa Rigpa and Homoeopathic drugs and proposes to develop new innovative drugs by establishing their scientific research board. Owing to the new suggestions put forth in this new draft an opinion is addressed in this letter concerned with quality

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Mange, Ram* Vipin Kukkar. "A Review On Drug Master File." International Journal in Pharmaceutical Sciences 2, no. 10 (2024): 806–11. https://doi.org/10.5281/zenodo.13936077.

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Master file on drugs A "DMF" is a document that includes details about the procedures, facilities, or materials used in the manufacturing, processing, packing, and storage of one or more human pharmaceuticals. A DMF contains information about the chemistry, manufacturing, and control of a drug component. A DMF is filed when two or more companies work together to develop or produce a medicinal product. Businesses can protect their partner's intellectual property by completing a DMF and following the regulatory requirements for processing information disclosure. Details about a drug formulation'

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