Streamlining Variations

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Earlier this year, in March 2024, the European Commission set out its new measures for the European Union’s variation framework (1). These new measures have been consulted upon by industry stakeholders and are anticipated to improve the efficiency of lifecycle management of medicines authorizations.

The last time changes were made to the variation framework was 12 years ago, and since that time, industry has experienced scientific and technological progression (2). Additionally, during the past 12 years, the number of variation requests has also increased, which has augmented the administrative burden on the European Medicines Agency and regional regulatory authorities (1).

Any and all variations to a marketing authorization of a medicine are assessed by regulatory authorities. Variations are separated, depending on the level of risk the variation would pose to public health, into categories (2). For example, a change of address for the drug company, would be classified as an administrative variation; a change of a medicine’s name, would be classified as a minor variation; and a change to the pharmaceutical form, would be classified as a major variation (3).

With the new revisions to the variation framework, the commission expects that more minor variations, such as administrative ones, can be streamlined by allowing marketing authorization holders to report such changes on an annual basis instead of immediately notifying the relevant regulatory authority. Furthermore, the revisions have taken into account the industry’s improved understanding and experience with some biological medicines, which could allow for 10–20% of major variations to be reclassified as minor (2).

These revisions are a part of the commission’s larger pharmaceutical strategy, and on pages 13–14 of this issue, you can read more about the changed variation framework in our Europa Perspectives series. The full video interview with Alexander Natz is also available to view online at www.PharmTech.com/view/europa-perspectives-on-lifecycle-management.

References

1. EC. Commission Proposes New Measures for the Better Lifecycle Management of Medicines Authorisations. EC.europa.eu, e-News, 12 March 2024.
2. EC. Commission Staff Working Document Accompanying the Document Commission Delegated Regulation (EU) …/… Amending Regulation (EC) No. 1234/2008 as Regards the Examination of Variations to the Terms of Marketing Authorizations for Medicinal Products for Human. Brussels, Belgium (11 March 2024).
3. EMA. Variations Including Extensions of Marketing Authorisations. EMA.europa.eu (accessed 11 April 2024)..

About the author

Felicity Thomas is the European/senior editor for Pharmaceutical Technology Group.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 4
April 2024
Page: 6

Citation

When referring to this article, please cite it as Thomas, F. Streamlining Variations. Pharmaceutical Technology Europe 2024 36 (4) 6.