Regulatory affairs

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sekhara

Tecnología Empresariales

Drug Regulatory Affairs The Backbone of Pharmaceutical Industry .

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What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like: USFDA(USA) MHRA(UK) TGA(Australia AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices. Promoting public health by helping people who use these productsto understand their benefits and risks. Improving public health by encouraging and facilitating developments in products that will benefit people GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK. Inspected UK Contract GMP Quality Control Laboratories. BLUE GUIDE: Advertising and Promotion of medicines in the UK. ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors. Good Pharmacovigilance Practice Guide. Guidelines on Process Validation Guide to UK GLP Regulations 1999 Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products. Guide to defective medicinal products. Introduction of a Risk Based Inspection Programme for GMP Labs. SALIENT FEATURES, COMMITTEES/WORKING GROUPS:- MHRA has the power to withdraw a product from market and suspend production of medicines. A manufacturer or distributor can be prosecuted if the law has been broken. Regulatory decisions are impartial D Different products are treated differently. MHRA collaborates with : US Food and Drug Administration NPSA National Patient Safety Agency NICE National Institute for Health and Clinical Excellence

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