Compliance with good manufacturing practice (“GMP”) is mandatory for all medicinal products that have been granted a marketing authorisation. Likewise, the manufacture of investigational medicinal products must be in accordance with GMP. Advanced therapy medicinal products that are administered to patients under Article 3(7) of Directive 2001/83/EC1 (so called “hospital exemption”) must be manufactured under equivalente quality standards to the manufacturing of advanced therapy medicinal products with a marketing authorisation.
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- Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples
- FARMACOVIGILÂNCIA nível avançado : Formação completa con casos práticos
- FDA DRAFT GUIDANCE :Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
- European Biotech Act: Positioning EU as Biotech Powerhouse
- CIOMS Glossary of ICH Terms and Definitions. Version 10
- Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1
- MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
- Commission Implementing Decision amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer