Regulatory Manager: What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products Part 3: Submission of the Marketing Application

| 01 October 2009

The completion of Phase 3 clinical trials, along with completing the definition of the manufacturing process and product, is a major milestone for a biotech company. Activities now focus on preparing the appropriate marketing application for the US Food and Drug Administration (FDA) (the New Drug Application (NDA) for biotech hormones and the Biologics License Application (BLA) for all other biotech products) and/or for the European Medicines Agency (EMEA), which uses the Marketing Authorization Application (MAA) for all biotech products. The goal of this submission from a CMC perspective is to provide enough information to permit the respective regulatory authority to determine whether the methods used in manufacturing the biotech drug and the controls used to maintain its quality are appropriate and adequate to ensure the drug's identity, strength, quality, purity and safety.


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