Regulatory News - March 2018

1. EMA issued the following publications:

• Strengthening standards, transparency, and collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
• The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendations.

2. EMA has released for public consultation a draft guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Revision 2.

3. The EMA publishes a monthly “Human Medicines Highlights” Newsletter, which is addressed primarily to patients, consumers, healthcare professionals and their organisations. The latest edition of the Newsletter is available by clicking here. Previous editions can also be found on this page.

4. Following the safety recommendation and the public hearing on valproate, PRAC recommends new measures to avoid valproate exposure in pregnancy.

5. Ukraine now accepts RMPs written according to the EU format as per GVP V Rev. 2.

6. EMA has published a question-and-answer document addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines. The Q&A document is available by clicking here. For more information about orphan designation please click here.