Earlier today (30 September 2022) to ensure British people have timely access to medicines, the European Commission Decision Reliance Procedure has been extended by 12 months to 31 December 2023, while the MHRA develops proposals for a new international reliance framework.
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).
Based on the EMA's decision, the MHRA is capable of granting a licence with a lighter touch than it would normally conduct for that medicinal product.
It has been decided to extend the European Commission Decision Reliance Procedure (ECDRP) until 31 December 2023 to allow the EU to develop the right strategies to take advantage of the opportunities of being a sovereign regulator.
The mitigation ensures that companies do not deprioritize GB for medicines authorisation, ensuring that patients can access medicines in a timely manner.
This extension will ensure GB patients continue to access the latest innovative medicines that meet high standards of safety as soon as possible.
Click this LINK to know more about the European Commission Decision Reliance Procedure (EC DRP) Extension.
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