On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
EUROPEAN COMMISSION CLARIFIES POSITION ON POST-AUTHORISATION EFFICACY STUDIES
According to the Community Code on Medicinal Products, the European Medicines Agency ("EMA"), the Commission or the competent authorities of the EU Member States may request the marketing authorisation holder of a medicinal product to conduct a post-authorisation efficacy study in certain circumstances. These circumstances include concerns relating to the efficacy of the medicinal product which can only be resolved after the medicinal product has been authorised; or if the further understanding of the disease, the clinical methodology or the post-authorisation use of the medicinal product indicate that previous efficacy evaluations would require significant revisions.
To supplement the provisions of the Community Code on Medicinal Products, the Commission adopted the Delegated Regulation to determine the circumstances in which these post-authorisation efficacy studies may be required.
In accordance with the Delegated Regulation, the EMA, the Commission or the competent authorities of the EU Member States may request pharmaceutical companies to conduct post-authorisation efficacy studies in a number of circumstances which are as follows:
- If the initial efficacy assessment was based on surrogate endpoints.
- To resolve uncertainties about combination medicinal products.
- To resolve uncertainties about the efficacy of a medicinal product in certain sub-populations that could not be resolved prior to marketing authorisation.
- If a potential lack of long-term efficacy raises concerns about a positive benefit-risk balance of the medicinal product.
- If the benefits of the medicinal product are significantly affected by real-life conditions.
- A change in the standard of care for a disease or the pharmacology of a medicinal product that requires additional evidence on its efficacy.
- If new concrete and objective scientific factors may require previous efficacy evaluations to be revised significantly.
The EMA, in collaboration with the EU Member States, will publish scientific guidance governing the design of the post-authorisation efficacy studies which are provided for in the Delegated Regulation.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017