PHARMACEUTICAL LEGISLATIONS PPT/PDF

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Sure, pharmaceutical legislation is a complex topic, but here are three key aspects:Regulatory Approval Process: This involves the steps a pharmaceutical product must go through to gain approval for sale and distribution. It includes preclinical studies, clinical trials, and regulatory submissions to agencies like the FDA in the United States or the EMA in Europe.Quality Control and Manufacturing Standards: Legislation sets standards for the manufacturing, packaging, labeling, and distribution of pharmaceutical products to ensure their safety, efficacy, and quality. Good Manufacturing Practices (GMP) are a crucial part of this.Drug Pricing and Access: Governments often regulate drug pricing to ensure affordability and access for patients. This involves balancing the need for innovation with the need to provide affordable healthcare. Pharmaceutical legislation can also include provisions for generic drug approval and patent protection.