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- Providing regulatory submissions in electronic format February 26, 2020
- ICH S5 (R3) guideline on reproductive toxicology February 22, 2020
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials February 22, 2020
- 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
- Parliamentary News
- Shortage of medicines March 4, 2020
- Treatment of rare illnesses February 28, 2020
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- Slow progress by EU in combating antimicrobial resistance February 26, 2020
- Details regarding the works at the European Medicines Agency February 26, 2020
