Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders
Mulder, Jorn; Verjans, Robin; Verbaanderd, Ciska; Pean, Elias; Weemers, Just; Leufkens, Hubert G.M.; Pignatti, Francesco; de Boer, Anthonius; Voest, Emile E.; Stoyanova-Beninska, Violeta V.; Pasmooij, Anna M.G.
(2021) Frontiers in Medicine, volume 8, pp. 1 - 5
(Article)
Abstract
After marketing authorisation, the development of a medicinal product often continues with studies investigating new therapeutic indications. Positive results can potentially lead to changes to the terms of the marketing authorisation, such as an extension of therapeutic indication(s). These studies can be initiated and sponsored by the marketing authorisation holder
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(MAH) or by others. When results from an investigator-initiated trial suggest that an authorised medicinal product is safe and effective for a new therapeutic indication, physicians may want to treat their patients with this medicinal product. In such a situation, it is desirable to extend the therapeutic indication(s) via the regulatory approval process, as this can facilitate patient access within the European Union. There may however be challenges when the MAH did not conduct the study and might not have access to the data. In this perspective, we focus on the possibilities to extend the therapeutic indication(s) of an already authorised medicinal product based on results from investigator-initiated trials. We address: (1) the advantages of an extension of indication; (2) the regulatory requirements for a variation application; (3) investigator-initiated trials as a basis for regulatory approval; (4) the role of the MAH in extending the indication. With this article, we want to emphasize the importance of a collaborative approach and dialogue between stakeholders with the aim to facilitate access to effective medicinal products.
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Keywords: anti-cancer medicinal products, European Medicines Agency, extension of therapeutic indication, investigator-initiated trials, regulatory approval, General Medicine
ISSN: 2296-858X
Publisher: Frontiers Media S.A.
Note: Funding Information: We would like to thank all participating stakeholders for their contribution to the RSNN expert meeting held on 23 June 2020. Furthermore, we would like to acknowledge Max Polano, Carla Jonker, and Kora Doorduyn?van der Stoep for their thoughts on the initial concept and Kyriaki Tzogani, Christelle Bouygues and Caroline Pothet for their critical comments and feedback on the draught manuscript. Publisher Copyright: Copyright © 2021 Mulder, Verjans, Verbaanderd, Pean, Weemers, Leufkens, Pignatti, de Boer, Voest, Stoyanova-Beninska and Pasmooij.
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