MHRA extends European Commission Decision Reliance Procedure to 31 December 2023

United KingdomScotland

On 30 September 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) announced that the European Commission Decision Reliance Procedure (ECDRP) has been extended by 12 months to 31 December 2023.

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

As the UK is no longer an EU Member State, any marketing authorisations (MAs) granted by the European Commission under the Centralised 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 rely on a European Commission decision to grant a new MA. This means the MHRA can perform a “lighter touch” review for that medicine, relying on the same dossier reviewed by CHMP and with access to all CHMP assessment reports. The MHRA decision is fast-tracked, being issued at the latest 67 days from the date of the CHMP positive opinion (provided the submission is filed within five days of the CHMP opinion).

The extension of the ECDRP will be welcome news for companies planning their MA filing strategies, but also for patients in Great Britain. The MHRA has acknowledged the risk of companies deprioritising Great Britain as a market without this procedure. By tying in the MHRA review timeline with the CHMP opinion, the aim is that the GB market will not fall out of step with the EU.

What will happen after 31 December 2023 has not yet been announced, although we do know that the MHRA is developing proposals for a new international reliance framework. Timely confirmation of what this framework will look like will be helpful to enable companies to plan their filing strategies for pipeline products.