Regulations and standard
Pharmaceutical Standards and Regulations
Pharmaceutical standards and regulations ensure the safety, efficacy, and quality of drugs and medical products worldwide. Regulatory authorities like the US FDA (USA), EMA (Europe), MHRA (UK), PMDA (Japan), and CDSCO (India) establish strict guidelines for drug development, approval, and manufacturing. These agencies enforce GxP compliance, clinical trial regulations, and pharmacovigilance to protect public health. Each body has region-specific requirements, but all aim to maintain global harmonization through ICH and WHO standards. Adhering to these regulations is critical for market authorization and ongoing compliance.
US FDA Regulations
- 21 CFR Part 211: Electronic Records, Electronic Signatures
- 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
- 21 CFR Part 312: Investigational New Drug Application
- Draft Guidance for Industry and food and drug administration staff: Computer software assurance for production and Quality System software
- Draft Guidance- AI: Considerations for the use of Artificial intelligence to support regulatory decision-making for drug and biological products
- Guidance for Industry: Computerized System used in Clinical Trials
European Medicines Agency (EMA)
Medicines and Healthcare products Regulatory Agency
US FDA Regulations
Central Drugs Standard Control Organisation (CDSCO)
