National Journal of Pharmaceutical Sciences
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P-ISSN: 2788-9262, E-ISSN: 2788-9270

National Journal of Pharmaceutical Sciences


2022, Vol. 2, Issue 2, Part B
Pharmaceutical regulatory agencies


Author(s): Deepak Kumar, Dr. Jigger Vyas and Dr. Umesh Upadhyay

Abstract: As the pharmaceutical businesses throughout the world become more competitive, regulatory agencies are being formed in a variety of nations around the world. Regulatory authorities and organizations play an important part in meeting the legal requirements of a country's drug development process. Pharmaceuticals are currently one of the most heavily regulated businesses in the world. The regulatory body guarantees that all legal and regulatory elements of a medicine are followed. Every nation has its own regulatory authority, which is in charge of enforcing laws and regulations as well as issuing guidelines to govern the drug discovery process, licensing, registration, manufacturing, marketing, and labelling of pharmaceutical goods. The few regulatory agencies and organizations established in respective countries include the USFDA (USA), MHRA (UK), TGA (Australia), CDSCO (India), health Canada (Canada), MCC (South Africa), ANVISA (Brazil), EMEA (European Union), SFDA (China), NAFDAC (Nigeria), MEDSAFE (New Zealand), MHLW (Japan), MCAZ (Zimbabwe), SWISSMEDIC (Some of the international regulatory agencies and organizations that play an important role in all aspects of pharmaceutical regulations include the World Health Organization (WHO), Pan American Health Organization (PAHO), World Trade Organization (WTO), International Conference on Harmonization (ICH), and World Intellectual Property Organization (WIPO). The key problems for these regulatory authorities and organizations worldwide are to assure the safety, quality, and efficacy of medicines and medical devices, to harmonize legislative procedures connected to drug development, and to monitor and ensure compliance with statutory requirements. They also play an important role in ensuring and increasing regulatory implementation in non-regulated areas of the world to protect the safety of those who live there. The current research provides a brief overview of key developed and developing nations' regulatory bodies, as well as the scope and problems of such regulatory organizations in medication development and the delivery of safe and effective healthcare goods to citizens worldwide.

Pages: 164-168 | Views: 22 | Downloads: 9

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How to cite this article:
Deepak Kumar, Dr. Jigger Vyas, Dr. Umesh Upadhyay. Pharmaceutical regulatory agencies. Nat J Pharm Sci 2022;2(2):164-168.


National Journal of Pharmaceutical Sciences