On April 26, 2023, the European Commission published a draft of a new pharmaceutical directive and regulation to replace the existing EU pharmaceutical legislation, which has been in force for 20 years.
The proposals provide for a reduction in the current periods of regulatory data protection, with the possibility of prolonging them – where a medicine is launched in all EU Member States, or where a medicine addresses an unmet medical need or a clinical trial with a control group is conducted, and where a new indication is added. As a result, the duration of data and market protection can be up to 12 years in total. In addition, the “Bolar amendment” will be modified. The drafts also provide a simplification of registration procedures by, among other things, shortening processing times and digitalizing the procedure. The new regulation will allow temporary marketing authorisations to be granted in the event of a public health emergency and will also introduce new reporting obligations for drug shortages. The previously existing separate regulations for orphan and pediatric medicines will be repealed and their provisions will be incorporated into the new regulation as appropriate.
The proposals will now be forwarded to the European Parliament and the Council for further legislative work.
Legal basis:https://health.ec.europa.eu/system/files/2023-04/com_2023_193_1_act_en.pdf
https://health.ec.europa.eu/system/files/2023-04/com_2023_192_1_act_en.pdf
