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 cutaneous manifestations of epidermolysis bullosa June 19, 2018
- Nonclinical evaluation for anticancer pharmaceuticals June 15, 2018
- Evaluation of medicinal products indicated for treatment of bacterial infections June 14, 2018
- Developing systemic drug products for pre-exposure prophylaxis of HIV-1 infection June 14, 2018
- Limited population pathway for antibacterial and antifungal drugs June 13, 2018
- Parliamentary News
- Proportionality test before adoption of new regulation of professions June 15, 2018
- Depakine and other medicines containing valproate June 8, 2018
- Scientific data on aluminium in vaccine adjuvants June 6, 2018
- Fixed spending and incentive system under Spanish Government agreement with Farmaindustria June 6, 2018
- Measures to introduce transparency in the pricing of medicines June 2, 2018
