FOI release

Freedom of Information request (FOI 22/1007)

Published 17 January 2024

28th October 2022

FOI 22/1007

Dear

Thank you for your information request, dated 2 October 2022, where you asked:

Please can you send me MHRA’s internal document(s) which describes the skills, qualifications, experience and training which MHRA requires of those people in MHRA with the delegated power to Authorise medicines for public use, and the process for assessing and reviewing this.

a) the current number of posts where the role includes the Authorisation of medicines for public use which are : i) filled; ii) vacant

Answer: The number of posts where the role includes direct contributions to the authorisation of medicines, i) 126 posts filled* and ii) 32 vacant*

*Please note, the figures above were obtained from a report generated on Monday 17 October date i.e., after receipt of your request. We understand that, under regular processing, an FOI request is for data held at the time of our receipt of the request, however, the Agency has recently undergone a restructuring exercise and in order to capture the new role structure, a more recent report had to be compiled. The number of posts above reflect resources across both departments Healthcare Quality and Access and Safety and Surveillance (35 posts). The figures above include some high-level managerial positions, specifically, managerial posts where the manager possesses regulatory, scientific and technical expertise which can contribute to assessments.

Clinical Trials Statement

Please note, we have not included staff specifically involved in the processing and assessment of UK clinical trials as we do not consider that this falls under the scope of your query regarding incumbents involved in the authorisation of “medicines for public use”, since clinical trials are conducted in strictly defined populations controlled by inclusion and exclusion criteria specified in a trial protocol. However, we can confirm that the competency development framework for these assessors follows that as described for staff involved in the assessment of marketing authorisation applications for public use. The above applies to all parts of your request.

Safety and Surveillance statement

There are approximately 35 assessors in Benefit Risk Evaluation (in post) who work on the safety and surveillance aspects of placing medicines on the market e.g. the risk management plan. However, the final decision does not lie with Safety and Surveillance/Benefit Risk but with HQA. Safety and Surveillance/Benefit Risk

Administrative staff which possess delegated power

We have not included posts which do not have an assessment based role but do have delegated power e.g. issuing of a grant letter once an application has been assessed with a positive outcome.

Parallel Imports

We have not included posts related to parallel imports as these products do not follow the standard assessment procedure.

CHM statement

Decisions to authorise new products are made with advice from the Commission on Human Medicines (CHM), the government’s independent expert scientific advisory body. The CHM is supported by groups of experts e.g. expert advisory committees and Expert Working Groups. Please find the membership lists alongside further details of the CHM and group activities below.

https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership

Devices

In your request you specified “this FOI request covers only medicines not medical products” therefore, we have omitted posts related to medical devices.

b) the current number of filled posts where the incumbent has been assessed as competent to Authorise medicines for public use;

Answer: Please refer to the job descriptions located in the appendices. These documents include the position requirements. Please also refer to the competency development framework (CDF) documents also located in the appendices. Training and accreditation are tailored to the specific requirements of the role, and training largely takes place in-house according to CDF. Please note, given the re-structuring of the Agency CDF is currently under review. Some assessors will also have additional qualifications for example doctorates, and many will also attend discipline specific training provided through professional body memberships. The accreditation process ensures all staff operating within CDF have the appropriate regulatory and scientific knowledge and experience relevant to their role. All staff falling under CDF are expected to become accredited within a reasonable time frame dependent on their background, experience and role.

c) of a), the current number where the incumbent has been in post for less than 3 months

Answer:. There are 11 posts where the incumbent has been in post for less than 3 months. Figures covers posts in Safety and Surveillance and Healthcare Quality and Access.

We have not needed to apply any exemptions under FOI to meet your request. The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Yours sincerely,

MHRA Customer Experience Centre

Communications and engagement team