EMA-raadpleging: conceptdocument over de herziening van de richtlijn over de evaluatie van geneesmiddelen tegen kanker bij de mens

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The European Medicines Agency has released for public consultation a concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man.

This concept paper introduces revision 6 proposing amendments and add-ons to the last version of the guideline on the evaluation of anticancer medicinal products in man.

The upcoming revision 6 proposes a review of the concepts related to biomarkers, which are increasingly used to define malignant diseases and develop new treatment strategies, improve description of the regulatory standards relevant for rare cancers and additional minor amendments to other sections.

The draft paper is available by clicking here.

Comments should be provided using this template and sent to ONCWP@ema.europa.eu by 14 April 2019.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

For more information on the European regulatory system for medicines, please click here (brochure available in all languages).

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