There are a lot of pilots that MHRA started back in 2023. This is a short summary of the new initiatives and how they can be helpful for pharma and biotech companies.
International Recognition Procedure
This is the initiative with the biggest impact for all companies looking to obtain marketing authorisation in the UK. It is a straight forward process and a great example of international collaboration.
1. If you have drug approved in Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States in the last 10 years you may be eligible to apply for marketing authorisation recognition in the UK. It is important to remember that this does not apply for herbal medicines but only for medicinal products.
2. Within 6 weeks of apply for the program the applicants have to complete Eligibility form to confirm if their application falls within Recognition A or Recognition B category.
3. You have to use the European eCTD Modul 1-5 for the submission. Only MHRA Submission portal can be used for the submission.
4. Recognition A takes 60 calendar days for review (without clock stop) and Recognition B takes 110 calendar days for review with 1 clock stop at 70 days. If there are further issues Recognition A could be moved to Recognition B or even to National review process.
While you may argue that this is not necessarily an MHRA initiative it is something they have been involved in.
If you are importing drugs to Northern Ireland you have to look at the latest update on labelling requirements which was issued as part of Windsor Framework.
From 1 Jan 2025 all drugs on the UK market need to have ‘UK only’ label. The old EU labelling will be accepted by 31 Dec 2024. ‘UK only’ stickers could be used only by 30 Jun 2025.
If you are using commercially available drugs in clinical trials which are manufactured in EU countries and imported to the UK for the purpose of the clinical trial, this will affect you too.
The Innovative Devices Access Pathway (IDAP)
As part of the pilot companies can use scientific advice from MHRA. This pilot will be a great benefit for start ups and university researchers looking to create innovative medical devices and start their own testing.
It is not clear what will be the benefit (if any) of this program for already established medical device companies with products on the market.
Initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated.
While this is not necessarily new idea it is not broadly used. It may benefit investigator led studies and university research.
Consortium Promise Pilot Pathway
The Access Consortium working group includes Australia, Canada, Singapore and Switzerland. The group is reviewing new active substances which meet the following criteria:
- diagnoses, treats or prevents a condition that is serious, life-threatening or severely debilitating and
- for which no other treatment is currently registered and marketed in participating jurisdictions for the proposed indication
Each agency will review Module 1 and one agency will review Module 5 of the application. Each country will make it is own decision on the application. The working group needs at least 3 months notice prior the submission.
Regulatory Science and Innovation Networks (RSINs)
This is an initiative between Innovate UK, MHRA and government to connect academic institutions with other networks to help them develop innovative products. They can also access to additional funding.
Access New Active Substance and Biosimilar Work Sharing Initiatives
Similar to Consortium working group this initiative allows to submit in parallel to the UK, Australia, Canada, Singapore and Switzerland a biosimilar product. The recommendations are that while Module 2-5 could be different for each country the applicant to try to submit the same information which will support quicker review. Notification of such submissions have to be done 3-6 months prior the submission.
