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Revised version of EU GMP Annex 19: Reference and Retention Samples
In June 2026, the European Commission published a revised version of EU GMP Annex 19 – Reference and Retention Samples, applicable from 24 September 2026. Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on theCommunity...
Evaluation of Therapeutic Equivalence. Guidance for Industry
📆 August 2026 This guidance provides information regarding FDA’s therapeutic equivalence evaluations, including the assignment of therapeutic equivalence codes (or TE codes). As defined in 21 CFR 314.3(b), therapeutic equivalents are approved drug products...
FDA Considerations for the Regulation of Generative Al-Enabled Medical Devices: Discussion Paper and Request for Feedback
This paper is not intended to propose or implement policy changes regarding how CDRH intends to regulate generative AI-enabled devices. This paper is not intended to communicate CDRH’s proposed (or final) regulatory expectations, including its expectations for...
EMA Guidance for industry on implementing Shortage Prevention Plans (SPP)
The European Medicines Agency has issued an updated guideline to assist marketing authorisation holders (MAHs) to create and maintain drug shortage prevention plans (SPPs) for their products. The main objective of the SPPs is to ensure the MAH has appropriate systems...
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