Author: Dr Alexander Natz, LL.M.
On 26 April 2023, the draft of the EU Pharmaceutical Legislation was published.
This white paper addresses the new concept of the legislation, which will also include the Orphan Medicines Regulation and the Paediatric Regulation.
The roadmap for implementation is addressed here - although this will be somewhat interrupted by the EU parliamentary elections next year. Two major points of the legislation will be the concept of 'unmet medical need' and the modified Regulatory Data Protection Schemes. Overall, the legislation is expected to have a high impact on drug development and marketing in Europe.
Download now the white paper 'EU Pharmaceutical Legislation – The most important changes at a glance'.
We hope you enjoy reading it!
