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- Voluntary consensus standards related to pharmaceutical quality February 16, 2019
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- Principles of premarket pathways for combination products February 10, 2019
- Public warning and notification of recalls February 10, 2019
- Parliamentary News
- Health technology assessment February 15, 2019
- Orphan medicinal products February 13, 2019
- Implementation of the cross-border Healthcare Directive February 13, 2019
- Costs of moving the European Medicines Agency to Amsterdam February 12, 2019
- Drug cost sharing February 1, 2019
