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Drugs: Licensing

Question for Department of Health and Social Care

UIN 73983, tabled on 12 November 2021

To ask the Secretary of State for Health and Social Care, in the context of the reduction of Medicines and Healthcare products Regulatory Agency (MHRA) licensing assessors, what role the (a) European Medicines Agency, (b) USA's Food and Drugs Administration and (c) British standards institutions will have in approving new drug licences from 2022.

Answered on

22 November 2021

Following the United Kingdom’s exit from the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) has offered a range of new routes to market, including a rapid 150 day assessment procedures for new drugs and the Innovative Licensing and Access Pathway which aims to accelerate the time to market, facilitating patient access to medicines for life-threatening or seriously debilitating conditions or those where there is a significant patient or public health need. If companies already have a licence granted by the European Commission through the European Medicines Agency, they may request the MHRA to rely on the decision of the European Commission in granting an authorisation for Great Britain and the final decision to authorise is made by the MHRA. The European Commission’s authorisation is automatically valid for Northern Ireland.

The MHRA is now participating in two international work sharing collaborations, including Project Orbis, co-ordinated by the Food and Drug Administration to review and approve promising cancer treatments. However, each country remains fully independent on its final regulatory decision. Applications submitted to the MHRA within a Project Orbis procedure are national marketing authorisation applications and variations.