CURRENT APPROVAL PROCEDURE FOR NEW REGULATIONS, STANDARDS, POLICIES & GUIDENCE ISSUED BY REGULATORY AUTHORITES

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 efcacy 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

A regulatory process by which a person/organization/sponsor/innovator gets authorization to launch a drug in themarket, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article will focus the similarities and differences in drug approval process of various regulatory bodies.

Key Words: Drug approval process, clinicaltrials, marketing.