Welcome
Welcome to the latest edition of MHRA News, our monthly newsletter for industry. We are committed to keeping you updated on what is going on at the MHRA and this newsletter is part of a broad effort to ensure transparency and communication. We continue work to promote MHRA News across the sector to drive engagement and registration.
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Clinical trials and investigations performance
Our latest MHRA performance data as of 15th July shows that clinical trials applications continue to be handled within target statutory timescales.
Regulatory assessments for clinical trials have been completed in an average of 27 days for initial assessments (within the statutory timescale of 30 days) and an average of 27 days for assessments of amendments (within the statutory timescale of 35 days).
We have now embedded improvements in processing clinical trial applications into standard working practice. We will continue to make enhancements with new legislative measures to make it easier and faster for applicants to gain approvals and to ensure the UK remains a prime destination for clinical trials.
Our Notification Scheme, launched in October 2023, reduces the time to process applications by more than 50 percent, for those that meet the eligibility criteria. Register your interest.
More information about individual trial application status, is available by emailing clintrialhelpline@mhra.gov.uk
Established medicines
Progress continues to be made in the clearance of marketing authorisation applications for established medicines that are outside of statutory timescales.
International Recognition Procedure applications continue to be on track with 100% approvals in statutory timescales.
Since May 2024, we have made changes to the range of data we publish:
- We no longer report on reliance data, instead providing data about our performance in the International Recognition Procedure including innovative medicines (NAS – new active substances).
- We now publish data on the most requested information relating to timescales for validation, including validation of marketing authorisation and variation applications, patient information quality unit (PIQU) and compliance reviews. All these procedures are complying with expected timescales.
- We have been working to adjust our approach for assessments of marketing authorisation applications, to maximise the effectiveness and efficiency of the process changes implemented on 1 March and continue to review this process alongside ongoing work with stakeholders. We encourage those who wish to provide feedback on these process changes to contact us directly at info@mhra.gov.uk.
Updates to International Recognition Procedure guidance
Last month we updated our submission guidance for the International Recognition Procedure and eCTD on gov.uk, and we now provide a checklist for applicants to use to manage the quality of their applications. This ensures that applications are not unnecessarily delayed while we seek additional information from them. This update follows commitments made at the IRP webinar in April 24, the recording of which is now available.
Annual Report and Accounts 2023-24
We've published our Annual Report and Accounts 2023-2024, which provides an overview of our performance and the events that have had most impact on the Agency during the past year. Some key highlights from the report include:
- Continuing our robust and effective regulation, taking appropriate action on identified safety issues
- Building on strong international relationships and domestic partnerships to enable rapid access to safe new medicines and healthcare products
- Making substantial progress towards restoring our performance, including major improvements in performance monitoring, enabling clear oversight and rapid action where issues start to develop
- Remaining committed to independence, objectivity, and evidence-based decision-making to uphold and protect patient safety and public health as our highest priority
Read the full report here.
Product approval announcements
We have continued work to publish announcements to coincide with the conclusion of regulatory assessments, delivering on a key objective as listed within our corporate plan to build public trust and understanding of our work.
Keeping patients safe and enabling their access to high quality, safe and effective medical products are key priorities for us. The MHRA will keep the safety and effectiveness of these medicines under close review, as with all medicines.
To learn more about these latest approvals and keep up to date on our the vital work carried out by our approvals team visit our homepage.
Man who illegally imported unlicensed medicines sentenced
Get in touch
You can write to us, email us or call us to get in touch with the MHRA. Find out how near the bottom of our homepage.
For any comments and feedback on this newsletter, please email: info@mhra.gov.uk.
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