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- Determining when a REMS is necessary April 5, 2019
- General approach to establish a microbiological ADI April 5, 2019
- Marker residue depletion studies to establish product withdrawal periods in aquatic species April 5, 2019
- Revision 1 of ICH Q3D on elemental impurities March 30, 2019
- Draft ICH guideline E19 on optimisation of safety data collection March 30, 2019
- Parliamentary News
- Supplementary protection certificate for medicinal products April 18, 2019
- Sale of medicines online April 10, 2019
- Discharge 2017: European Medicines Agency (EMA) March 27, 2019
- Orphan medicinal products – follow-up question March 26, 2019
- Orphan medicinal products March 23, 2019
