On Friday 30 September, the Medicines and Healthcare products Regulatory Agency (MHRA) announced a 12-month extension of the European Commission Decision Reliance Procedure (ECDRP). The ECDRP route was scheduled to end on 1 January 2023, but will now continue until 31 December 2023.
The ECDRP allows the MHRA to adopt a very light-touch, abbreviated (two month) review for any product already centrally approved by the European Commission. It significantly reduces the burden on companies looking to commercialise such medicines in Great Britain as the same technical dossier can be submitted to both the EMA and MHRA.
In the press release announcing the extension, the MHRA states that the extension will “ensure British people continue to have timely access to medicines while MHRA develop proposals for a new international reliance framework”.
This announcement is welcome news for pharmaceutical companies seeking to launch medicinal products in the UK. However, it is a reminder that the regulatory challenges resulting from Brexit’s impact on the UK’s medicines framework remain largely unresolved.
We predict that this extension will be followed by others which extend other Brexit transitional arrangements for medicines and medical devices.