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Recentes
- FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”
- webinar INTELIGÊNCIA ARTIFICIAL NA INDÚSTRIA FARMACÊUTICA :IA EM CONTEXTO GxP (Annex 11, 22, EU AI Act , GAMP®)
- GESTÃO da DISPONIBILIDADE do MEDICAMENTO: “Formação muito útil !
- IMDRF Playbook for Medical Device Regulatory Reliance Programs
- IMDRF Considerations for the selection of IMDRF Adverse Event Terminology
- Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 15 – Qualification and Validation
- FDA Draft Guidance General Considerations for Patient Preference Studies February 2026
- Open consultation: Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices
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.