Volume : 11, Issue : 10, October – 2024
Title:
ROLE OF POST APPROVAL CLINICAL TRIALS FOR DRUG SAFETY
Authors :
S. Manohar *, A. Madhusudhan Reddy, S. Sunayana
Abstract :
MHRA (Medicines And Health Products Regulatory Agency) is the regulatory authority body for pharmaceuticals approval in the UK union. MHRA is formed by the merging of two separate agencies in 2003 i.e., Medicines Control Agency and Medical Device Agency. This agency works to maintain safety, quality and efcacy of the drug product before it enters into the country. The main aim of this work is to know about the practice and the regulatory requirements for the registration of a drug in the UK as per the regulations of MHRA. They are responsible for ensuring that the medicines and medical devices are acceptably safe and don’t cause any harm to the patients. MHRA provides a license which is a marketing authorization to the manufacturer, required before a drug is being used by the patients of that country. Good Manufacturing Practice (GMP) is the minimum requirement that a manufacturer should possess during the period of production of the drug product. New drugs are being invented and also being distributed as per the needs of the patients. It is known that no drug product is completely safe or is 100% safe for use, but MHRA tries to minimize as many problems regarding the drug so that patients will be provided with the best drug with minimal risk.
Key words: MHRA, United Kingdom, Product license, eCT
Cite This Article:
Please cite this article in press S.Manohar et al Role Of Post Approval Clinical Trials For Drug Safety..,Indo Am. J. P. Sci, 2024; 11 (10).
Number of Downloads : 10
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