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- Core summary for product characteristics for human albumin solution August 13, 2018
- Clinical investigation of recombinant and human plasma-derived factor VIII products August 13, 2018
- Core SmPC for human plasma derived and recombinant coagulation factor VIII products August 13, 2018
- Use of expansion cohorts in clinical trials for oncology drugs and biologics August 13, 2018
- Dissolution testing for immediate-release solid oral dosage forms with high solubility drug substances August 10, 2018
- Parliamentary News
- Change in the formula for Levothyrox and its consequences August 9, 2018
- Effects of Depakine on pregnant women August 8, 2018
- Brexit impact assessments: medicines, pharmaceuticals and medical and healthcare products August 2, 2018
- Pharmacovigilance and drug safety July 28, 2018
- Use of real-world data for medical research July 27, 2018
