The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
- Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- Transição de ensaios clínicos para o Regulamento Europeu (complemento à Circular Informativa N.º 088/CD/100.20.200 de 04/09/2023)
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Q&A ON TRANSITIONAL PROVISIONS FOR PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE COVERED BY ANNEX XVI OF THE MDR.
- European Commission Newsletter on medical devices | September 2023
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- EUDAMED Release notes Production v 2.12 September 2023.
- Regulatory Considerations for Prescription Drug Use-Related Software SEPTEMBER 2023