english.prescrire.org > Topics > Advancing healthcare policy > Advancing healthcare policy in Europe: a chronological recap of actions > 2019 Recap > Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (6/2019)

Advancing healthcare policy

Advancing healthcare policy in Europe: a chronological recap of actions

Advancing healthcare policy

A recap of actions in 2019
Prescrire's response to the EMA Regulatory Science strategy to 2025: refocus on public health mission as gatekeeper and strengthen pharmacovigilance (June 2019)

Paris, 26 June 2019

Prescrire called on the Agency to refocus its activities on its public health mission as an independent and impartial gatekeeper by requiring robust evidence for the pre-approval process, strengthened monitoring of approved medicines and pharmacovigilance activities and to guarantee full access to data and transparency. Prescrire invites EMA to require robust proof of evidence for the marketing authorisation based on comparative randomised clinical trials with meaningful endpoints.

In Prescrire’s view, the strategy proposed by EMA is unbalanced in giving very little emphasis on post-drug surveillance activities. The proposed objectives/recommendations outlined in the consultation paper are mainly industry/science/technology driven with little focus on clear regulatory merits and responsibilities. There is a continuous trend towards early interactions between companies and EMA such as scientific advice, flexibilities and faster marketing authorisations with a shift from pre-marketing approval evidence-collection towards an unclear post-approval assessment.

> Click here to download Prescrire's response (pdf, 185 Ko)