REGULATORY AFFAIRS IN THE PHARMACY MODULES

Harshada Sandeep Jadhav*, Pratiksha Anil Salunkhe, Sunil Maniraj Yadav, Dr. Shoheb Shaikh

The pharmaceutical industry plays a crucial role in regulatory affairs, ensuring the safety, efficacy, and quality of drugs, protecting human health, promoting consumer trust, and supporting innovation. Key terms include Active Pharmaceutical Ingredient (API), New Drug Application (ANDA), Clinical Trials, Good Manufacturing Practice (GMP), International Council for Harmonisation (ICH), Investigational New Drug (IND), New Drug Application (NDA), Orphan Drug, Pharmacovigilance, and Post-Marketing Surveillance. Regulatory Authorities like the FDA, EMA, and MHRA regulate drugs and have standard operating procedures (SOP) for specific tasks. Intellectual Property Rights (IPR) are granted to creators and owners of intellectual property. Exploratory development (ExPD) is an essential process for companies to achieve growth and improve product development success. And also specifications that key documents Batch manufacturing record, Manufacturing formula record and other Aspects like SOP are described. The preparation of dossiers for multiple countries and the CTD format, which reduces time and resources for global registration applications. The International Conference on Harmonization of Electronic Common Technical Documents revolutionizes pharmaceutical submission procedures. Regulatory affairs personnel help pharmaceutical companies maintain accurate records, comply with regulatory requirements, and ensure product quality and safety.