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Guidance Note on New Assessment Routes from 1 January 2021

From 1 January 2021 the MHRA is introducing changes to national licensing procedures. These include procedures to prioritise access to new medicines that will benefit patients. The MHRA Innovation Office is open to all innovation queries.

An integrated pathway will pull together expertise from across the MHRA and partners in the wider healthcare system such as NICE. From 1 January 2021, MHRA will introduce an accelerated procedure and will reach its opinion on approvability of marketing authorisation applications within 150 days of submission of a valid application.

The accompanying cover letter should detail the intention to seek orphan status or an MA under exceptional circumstances. The MHRA will operate a 'fixed submission date' system to facilitate consultation with the Commission on Human Medicines.

Assessment process will run in two phases totalling 150 days. Phase I including CHM consultation will be completed 80 days after clock start. Phase II assessment will begin on receipt of the applicant's responses.

Rolling Review is a new route for marketing authorisation applications. It offers on-going Regulatory input and feedback. Similar biological applications (biosimilar products) are also eligible for rolling review.

MHRA will publish further information on the details of the scheme in due course. For two (2) years from 1 January 2021, Great Britain will adopt decisions taken by the European Commission on the approval of new marketing authorisations.

Marketing authorisation applications should be submitted to the MHRA following receipt of the CHMP opinion. The UK will also have the power to take into account marketing authorisation decisions of EU Member States.

Guidance on supply of medicines from Northern Ireland to Great Britain under Unfettered Access will be provided in due course. Fees applicable to GB marketing authorisations taking account of an EU decision will be published in due course.

Source: MHRA guideline on Guidance note on new assessment routes from 1 January 2021

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