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International Journal of Pharmacognosy and Pharmaceutical Research

Vol. 5, Issue 1, Part A (2023)

Recent regulation, challenges in regulatory requirement and approval procedure of biological in India, US & Europe

Author(s):

Nitish Kumar

Abstract:

The current constraints on Regulatory Affairs show that various nations have distinct regulatory requirements that must be met to receive approval for new pharmaceuticals via the Marketing Authorization Application (MAA). Each nation has its own regulatory body that is responsible for enforcing existing laws and formulating new ones to manage the pharmaceutical industry. The regulatory body is responsible for enforcing this duty. After a lead therapeutic molecule has been identified, more research must be done outside of a clinical setting to demonstrate the treatment is both effective and safe before it can advance into human trials. Once an application has been submitted to the appropriate body in the country of interest, clinical trials can begin. Each of the three phases of the ongoing clinical studies strictly follows the protocol. An application must be filed with the relevant authorities before the substance may be sold legally. The application is sent to the relevant bodies for examination, and approval is granted if it is determined that the drug meets the necessary standards of quality, safety, and efficacy.

Pages: 06-12  |  236 Views  66 Downloads


International Journal of Pharmacognosy and Pharmaceutical Research
How to cite this article:
Nitish Kumar. Recent regulation, challenges in regulatory requirement and approval procedure of biological in India, US & Europe. Int. J. Pharmacogn. Pharm. Res. 2023;5(1):06-12. DOI: 10.33545/26647168.2023.v5.i1a.45
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