Guidance for Industry: cGMP for Phase 1 Investigational Drugs
Clinical research serves as the backbone of medical progress, transforming innovative scientific discoveries into potentially life-changing treatments. However, as the landscape for conducting these trials becomes more complex, understanding the regulatory framework and ensuring compliance is more important than ever. For Phase 1 investigational drugs, regulatory agencies such as the U.S. Food and Drug Administration (FDA), Health Canada, and the European Medicines Agency (EMA) play a pivotal role in ensuring the safety, quality, and consistency of these early-stage clinical trials. While investigational new drug (IND) applications are being processed and drugs are tested for the first time in humans, the manufacturing processes must still adhere to strict standards—though these standards can vary depending on the regulatory jurisdiction. Exemption for Biological Drugs under 21 CFR Part 211 and Global Regulatory Perspectives Under Section 501(a)(2)(B) of the Federal Food, Drug, and Co...
