Recent drug regulatory affair and CTD module progress review for submission of pharmaceuticals product

Vaibhav Subhash  Janjal; Snehal Ramdas  Dhamodkar; Yogesh Pralhad  Jadhao; Sima Baburao  Manmode; Anil Keshav  Pawar; Harshada Ravindra  Khandelwal

doi:10.30574/gscbps.2021.16.3.0279

Authors

Vaibhav Subhash Janjal Department of Quality Assurance Techniques, Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune, Maharashtra, India, 411018.
Snehal Ramdas Dhamodkar Department of Quality Assurance Techniques, AISSMS COLLEGE OF Pharmacy, Sangamvadi, Pune, Maharashtra, India, 41001.
Yogesh Pralhad Jadhao Department of Quality Assurance Techniques, Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Maharashtra, India, 411044.
Sima Baburao Manmode Department of Pharmacology &Toxicology, Bombay College of pharmacy, Kalina Santacruz east, Mumbai, Maharashtra, India 400098.
Anil Keshav Pawar Department of Quality Assurance, R. C. Patel Institute of Pharmaceutical Education and Research, Dist.- Dhule, Shirpur, Maharashtra, India, 425405.6
Harshada Ravindra Khandelwal Department of Pharmaceutics, R. C. Patel Institute of Pharmaceutical Education and Research, Dist.- Dhule, Shirpur, Maharashtra, India, 425405.

DOI:

https://doi.org/10.30574/gscbps.2021.16.3.0279

Keywords:

Regulatory affairs, Regulatory Agencies, FDA, eCTD, Regulatory market

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.

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