The European Medicines Agency recently launched a public consultation on a draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
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News from EIPG
Regulatory News
- Investigational advanced therapy medicinal products in clinical trials February 22, 2019
- Competitive generic therapies February 22, 2019
- Voluntary consensus standards related to pharmaceutical quality February 16, 2019
- Clinical investigation of medicinal products for the treatment of gout February 10, 2019
- Developing drugs for treatment of eosinophilic esophagitis 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