MHRA extends appeals against European Commission decisions until 31 December 2023


The ECDRP was introduced after Brexit as a temporary measure to try to ensure continued access to new medicines for patients in Britain.

As the UK is no longer an EU Member State, any marketing authorization (MYs) granted by the European Commission under the centralized procedure do not apply in Great Britain. Instead, a separate MA granted by the MHRA is required.

The ECDRP was therefore launched to enable the MHRA to take advantage of a decision by the European Commission to grant a new MA. This means that the MHRA can carry out a ‘lighter’ review for this medicine, relying on the same dossier reviewed by the CHMP and with access to all of the CHMP assessment reports. The MHRA decision is expedited, being made no later than 67 days from the date of the positive CHMP opinion (provided the submission is made within five days of the CHMP opinion).

The extension of the ECDRP will be good news for companies planning their MA filing strategies, but also for patients in Great Britain. The MHRA has acknowledged the risk of companies deprioritizing Britain as a market without this procedure. By linking the MHRA review schedule to the CHMP opinion, the aim is that the UK market is not out of step with the EU.

What will happen after December 31, 2023 has yet to be announced, although we are aware that the MHRA is developing proposals for a new international trust framework. Timely confirmation of what this framework will look like will be helpful for companies to plan their filing strategies for pipeline products.

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