The US Food and Drug Administration (FDA) and The European Medicines Agency (EMA) have published new guidelines or draft guidelines.
FDA Guideline updates:
FDA Guidance for Industry – Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products – Questions and Answers. Draft guidance.
This guidance provides clarity on the postapproval manufacturing changes for licensed biosimilars and interchangeable biosimilars, detailing the nature and type of information required for different reporting categories.
Click here to read the complete guideline.
FDA Guidance for Industry – Container Closure System and Component Changes: Glass Vials and Stoppers.
The document outlines recommendations for application holders on reporting and implementing changes to container closure system components, focusing on glass vials and stoppers, and provides pathways for obtaining Agency feedback.
Click here to read the complete guideline.
EMA Guideline update
Guideline on the chemistry of active substances.
Key Changes: Amendments focus on nitrosamines and evaluation of mutagenic impurities mainly, manufacturing process and controls, materials control, impurities and stability summary. The status of the guideline remains a draft.
Asphalion experts are on top of these developments, ensuring our clients stay ahead of the curve and in full compliance with regulatory standards.
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