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- Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management December 7, 2019
- Establishing effectiveness of drugs for treatment of IC/BPS December 7, 2019
- Development of corticosteroid products for the treatment of symptoms associated with hemorrhoids December 7, 2019
- 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
- Parliamentary News
- Germany and enforced parallel importing of medicines December 6, 2019
- Slow progress by EU in combating antimicrobial resistance December 3, 2019
- Treatment of rare illnesses November 29, 2019
- Shortages of medicines in the European Union November 28, 2019
- The new Commission’s proposals to tackle shortages of medicines November 23, 2019
