News & Trends
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Recentes
- FDA Guidance for Drug Development
- Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
- IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
- GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
- MHRA Open consultation Draft rare disease therapies regulatory framework
- EU Delegated Acts on Well-Established Technologies (WET) under the MDR
- CLINICAL TRIALS: EMA CTIS Sponsor Handbook
- Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples
SCOPE AND ORGANISATION
The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all medicinal products for human use. It supports various submission types, including those referring to or consisting of master files, and applies to both initial marketing authorisation and post-approval submissions. This guideline is structured to be flexible to accommodate all types of medicinal products and their components.