The European Commission recently launched a targeted stakeholders consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the Eudralex Volume 4. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
Regulatory News- Developing drugs for treatment of Fabry Disease August 11, 2019
- General considerations for clinical studies August 2, 2019
- Clinical pharmacology considerations for neonatal studies for drugs and biological products August 2, 2019
- Pathology peer review in nonclinical toxicology studies August 2, 2019
- Nonclinical studies and labeling recommendations for oncology therapeutic radiopharmaceuticals August 2, 2019
- Parliamentary News
- Certification by notified bodies under the Medical Devices Regulation (MDR)(EU 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVD) (EU 2017/746) July 27, 2019
- EU and Member States’ roles in tackling Alzheimer’s July 20, 2019
- Medicine shortages in the Member States July 16, 2019
- Languages used on the packaging and instruction leaflets of medicinal products July 13, 2019
- Air transport of medicines to the Outermost Regions (ORs) July 13, 2019
