European Commission Decision Reliance Procedure extension

European Commission Decision Reliance Procedure has been extended by 12 months to apply across Great Britain until 31 December 2023, to ensure British people continue to have timely access to medicines while MHRA develop proposals for a new international reliance framework.

The launch of new medicines has long lead times and regulatory strategies are planned months or years in advance. To provide suitable timeframe for the right strategies to be developed that capitalise on the opportunities of being a sovereign regulator, the European Commission Decision Reliance Procedure (ECDRP) will be extended until 31 December 2023. This essential mitigation reduces the risk of companies deprioritising GB for medicines authorisation and therefore ensures patients continue to have timely access to medicines.

The European Commission Decision Reliance Procedure (EC DRP) allows a company to submit a product that has received approval from the EMA to the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA can grant a licence with a lighter touch review than they would normally conduct for that medicinal product, relying on the EMA’s decision.

The Medicines and Healthcare products Regulatory Agency (MHRA) has extended the EC DRP to apply until 31 December 2023, in order to ensure GB patients continue to access the latest innovative medicines that meet high standards of safety as soon as possible.

/Public Release. This material from the originating organization/author(s) may be of a point-in-time nature, edited for clarity, style and length. The views and opinions expressed are those of the author(s).View in full here.