Europa Perspectives on Lifecycle Management

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In November 2020, the European Commission’s pharmaceutical strategy, which laid out plans for several legislative and non-legislative actions to be launched, was adopted (1). A revision to the variation framework formed a part of the strategy plans, and on March 11, 2024, a delegated regulation amending the framework was finalized (2). The revisions to the variation framework are expected to reduce the administrative burden for industry and also free up the regulatory authorities’ time with regards to marketing authorization procedures.

Initially announced in April 2023, the proposed changes to the framework have undergone consultation from industry stakeholders. The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), which is a trade body that advocates for policies that support innovation, was involved in the consultation of the revisions, providing a response to the commission’s call for evidence (3) and feedback on the draft delegated regulation (4).

To find out more about the delegated regulation on variations and the impact it may have on both the European and global pharma industries, Felicity Thomas, Europe/Senior editor for Pharmaceutical Technology Europe^® spoke with Alexander Natz, secretary general at EUCOPE. Watch the video interview below:

This interview forms part of the Pharmaceutical Technology Europe^® Europa Perspectives series. In the inaugural installment of this series, Steffen Thirstrup from the European Medicines Agency gave an overview on regulatory challenges in Europe. Click below for this content:

European Medicines Agency Viewpoint

Europa Perspectives—Pan European Challenges and Solutions Post Brexit

Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers

Europa Perspectives: Helping to Navigate the Regulatory System

References

1. EC. A Pharmaceutical Strategy for Europe. Health.ec.europa.eu (accessed April 8, 2024).
2. European Parliament. Revision of the EU Variation Framework for Medicines (REFIT). Europarl.europa.eu (accessed April 8, 2024).
3. EUCOPE. EUCOPE Response to the European Commission Call for Evidence on the Revision of the Variation Framework for Medicines. Response document, Sep. 26, 2023.
4. EUCOPE. EUCOPE Feedback on the Draft Delegated Regulation on Variations. Feedback document, Feb. 29, 2024.