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- Adaptive designs for clinical trials of drugs and biologics December 1, 2019
- Product development and quality considerations for transdermal and topical delivery systems December 1, 2019
- Falsified medicines GDP inspection aide memoire November 19, 2019
- Developing drugs for treatment or prevention of smallpox infection November 19, 2019
- Clinical investigation of medicinal products for the treatment of gout November 16, 2019
- Parliamentary News
- Shortages of medicines in the European Union November 28, 2019
- The new Commission’s proposals to tackle shortages of medicines November 23, 2019
- Regulation (EU) 2017/745 on medical devices and the shortage of notified bodies in 2020 November 14, 2019
- Antibiotics taken off the market November 13, 2019
- Discharge 2018: European Medicines Agency (EMA) November 12, 2019
