EFPIA and Vaccines Europe statement on the revision of the EU variations framework

EFPIA and Vaccines Europe fully support the revision of the EU variations framework, recognising that this targeted first step aims to streamline procedures and ensure better handling based on a science and risk-based approach. We are encouraged to see the inclusion of positive changes such as the removal of the default type II classification for quality/manufacturing changes for biological products (including advanced therapies); the formalisation of the legal basis for the use of existing additional regulatory tools; the extension of Influenza vaccines approaches to Coronavirus vaccines; and reference to annual updates for all minor variations whilst retaining the flexibility of immediate submission in some cases, which is critical. We look forward to seeing the proposed revisions to the classification guideline later this year which will complete this initial update of the variation framework. We consider these targeted changes to be encouraging steps towards a more efficient, streamlined framework which may be fully realized after the update to the general pharmaceutical legislation.