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EMA & FDA Guidelines: Guiding Principles of Good AI Practice in Drug Development (2026)
This document outlines 10 guiding principles for the development and use of AI technologies across all phases of the drug product life cycle
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management
The document describes how multiple patient-specific product variants may be included in a single Biologics License Application (BLA) under section 351(a) of the Public...
Good manufacturing practice for medical devices (Announcement No. 107)
📄 Good manufacturing practice for medical devices (Announcement No. 107) Publisher: NMPA, China Publication date: 4 November 2025 Effective date: 1 November 2026 Format: Official Chinese-language document Download DOC → Summary China’s...
PIC/S PI 006-4: Recommendations on Qualification and Validation (October 2026)
PIC/S PI 006-4 establishes an updated, science- and risk-based framework for qualification and validation activities across pharmaceutical manufacturing.
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