Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product
1 Department of Quality Assurance Techniques, Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune, Maharashtra, India, 411018.
2 Department of Quality Assurance Techniques, AISSMS COLLEGE OF Pharmacy, Sangamvadi, Pune, Maharashtra, India, 41001.
3 Department of Quality Assurance Techniques, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Maharashtra, India, 411044.
4 Department of Pharmacology &Toxicology, Bombay College of pharmacy, Kalina Santacruz east, Mumbai, Maharashtra, India 400098.
5 Department of Quality Assurance, R. C. Patel Institute of Pharmaceutical Education and Research, Dist.- Dhule, Shirpur, Maharashtra, India, 425405.6
6 Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Dist.- Dhule, Shirpur, Maharashtra, India, 425405.
Review Article
GSC Biological and Pharmaceutical Sciences, 2021, 16(03), 200–221.
Article DOI: 10.30574/gscbps.2021.16.3.0279
Publication history:
Received on 18 August; revised on 24 September 2021; accepted on 26 September 2021
Abstract:
Regulatory Affairs (RA), also known as government affairs, is a relatively new profession that arose from governments' desire to protect public health by regulating the safety and efficacy of products such as pharmaceuticals, medical devices, pesticides, veterinary medicines, cosmetics, agrochemicals, and complementary medicines. Pharmaceutical regulatory affairs is concerned with the registration of pharmaceutical goods. All regulatory elements and guidelines connected to product filing are summarized in this evaluation. This study covers the whole CTD and eCTD submission process, as well as the modules that go with it. It also focuses on the key regulatory bodies across the world. Various roles of DRA departments, drug regulatory affairs professionals, the importance of drug affairs in pharmacy curriculum, emerging trends affecting regulatory strategy, regulatory affairs in product management, clinical trials, R&D and the drug approval process in the US, EU, and ROW market trends are discussed.
Keywords:
Regulatory affairs; Regulatory Agencies; FDA; eCTD; Regulatory market
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