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- Manufacture of ATMPs and biological medicinal substances and products for human use October 15, 2019
- Patient-focused drug development October 4, 2019
- Nonclinical assessment of investigational enzyme replacement therapy products October 4, 2019
- European Commission Safety Features Q&A document updated September 27, 2019
- Wholesale distributor verification requirement for saleable returned drug product September 27, 2019
- Parliamentary News
- Medicine shortages — legality of export restrictions October 2, 2019
- Shortages of medicines in the European Union September 26, 2019
- Antibiotics taken off the market September 25, 2019
- Paramiloydosis September 20, 2019
- 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) September 14, 2019
