Europe – Euro Regulatory Roundup

New guidances from the Medicines and Healthcare products Regulatory Agency (MHRA) address new assessment routes, marketing variation processes and rules on converting Community Marketing Authorisations (CAPs) that will apply to products sold in the United Kingdom post-Brexit.

The new assessment routes include an accelerated assessment pathway that, like its EMA equivalent, will reduce the regulatory review timeline to 150 days, according to the guidance.

The pathway is open to “good quality new marketing authorization applications for both new and existing active substances and submitted directly to UK.” Requests for conditional and full approval, as well as applications for authorization under exceptional circumstances, are eligible. MHRA plans to initially adopt EMA technical guidance on conditional and exceptional marketing authorizations.

MHRA also is creating processes more tailored to the UK. For example, MHRA is developing a “new medicine designation that links to the development of a roadmap to patient access in the UK healthcare system.” In practice, the plan will result in an integrated pathway intended to enable drug developers to access input from MHRA and other bodies including the National Institute for Health and Care Excellence (NICE).

The pathway could address one of the shortcomings of the European system – a disconnect between the marketing authorization and health technology assessment processes. By involving MHRA and NICE, the UK could make it easier for drug developers to get feedback on the evidence they will need to satisfy the demands of both agencies…