EMA Officials, Head of National Regulatory Agencies Begin Discussions in Post-Brexit Plan

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 05-02-2017 12:34


At a recent meeting held between European Medicines Agency (EMA) officials and the heads of the National Competent Authorities (NCAs) of the European Union (EU)/European Economic Area member states, discussion began on how the workload related to evaluating and monitoring medicines will be shared among member states without the UK, following its withdrawal from the EU (Brexit).

Although negotiations on the terms of the UK's departure have not yet officially begun and the outcome of those negotiations are unknown, the member states and the EMA will proceed based on the scenario that the UK will no longer participate in the work of the EMA and the European medicines regulatory system as of March 29, 2019, which marks the completion date of Brexit (two years after the UK government gave official notice of its intent to withdraw).

The general principles for workload distribution will include: ensuring business continuity; maintaining the quality and robustness of the scientific assessment; continuing to comply with legal timelines; ensuring knowledge retention, either by building on existing knowledge, or through knowledge transfer; assuring an easy implementation; and medium- and long-term sustainability.

It is expected that all NCAs will contribute to EMA activities as per the capacity and capability of each authority to optimize allocation of the workload across the network. The envisaged working methodology will include a mapping of current and future capacity and expertise in the network as well as identification of potential gaps. This methodology could help the network to increase its capacity in selected areas and would be supported with enhanced training opportunities.

Based on the general principles, EMA, its scientific committees, and working parties, together with the NCAs, will now assess the different options for workload distribution. A follow-up meeting is scheduled for July 5, 2017.

Source: European Medicines Agency


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