News & Trends
Procurar
Recentes
- EU MDR Update: New Harmonised Standards for Medical Devices
- Clinical evidence for orphan in vitro diagnostic medical devices
- Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
- TEAM NB Code of Conduct for Notified Bodies vs 5.3
- GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
- New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
- AI in pharmacovigilance – EMA update
- Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”
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.