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- Revision of Annex 1, on manufacturing of sterile medicinal products February 21, 2020
- Evaluation of the immunotoxic potential of drugs and biologics February 21, 2020
- Biosimilars and interchangeable biosimilars February 15, 2020
- Developing drugs for treatment of mucopolysaccharidosis type III February 15, 2020
- Promotional labeling and advertising considerations for biological reference and biosimilar products February 15, 2020
- Parliamentary News
- Spinal muscular atrophy (SMA) — Zolgensma — Novartis February 20, 2020
- Germany and enforced parallel importing of medicines February 11, 2020
- Price of asthma inhalers February 6, 2020
- Shortages of cancer drugs February 5, 2020
- Improving the efficiency of health systems January 30, 2020
