Last updated 25 October 2024
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The MHRA has published guidance on how to submit medicines pipeline information.
It is requesting current or potential medicines Marketing Authorisation Holders (MAH) to provide information on planned or potential future submissions to the MHRA.
The guidance:
- details how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
- provides information detailing how, what, and why the MHRA require this information to be submitted.
Why is the MHRA requesting this information?
Having advanced knowledge of expected submissions of all types, and requests for advice is key for the MHRA to effectively deliver its services to the highest quality and to be predictable with its assessment and advice timelines.
What information should be submitted to the MHRA?
Examples of data fields requested:
- Product Name
- Active Ingredient
- Product type (e.g. Chemical, Biological, Monoclonal Antibody)
- Indication
- Year/Quarter/Month expected submission date
- Expected submission route
- Additional MHRA services required (e.g. ILAP, Scientific Advice)
Any pipeline data submitted is not intended to be concrete and the MHRA will not be holding stakeholders to account based on this data. The MHRA are aware that circumstances and plans change over time and therefore the pre-submission team will keep records of incoming pipeline data and request updates on an approximate 6-monthly basis.
Who is the information being requested from?
All current or prospective Marketing Authorisation Holders are requested to contribute to the MHRA pipeline planning efforts irrespective of how many products a company has in its pipeline.
What will the MHRA do with the information that it collects?
The MHRA processes the information received this into a restricted master spreadsheet which has defined access across relevant parts of the organisation.
- The individual spreadsheets are then placed in locked secure folders to be held until an update is requested from the company.
- The MHRA keeps all data and information supplied securely and in line with the relevant regulations.
The MHRA acknowledges and respect that timelines change, new products are introduced to pipelines and products at any stage of development can be dropped from pipelines and will not put any definitive expectation on pipeline data submitted.
What are the benefits to you in providing this information to the MHRA?
The medicines pipeline data collected informs the agency of short to medium term demand on its services. This allows the agency to:
- Efficiently and accurately resource processing and assessment teams and ensure that colleagues have appropriate time to develop, in readiness of your applications
- Ensure consistent and predictable delivery of timelines for assessments and advice
- Highlight potentially transformative technologies early on and ensure that it has the appropriate expertise and regulations in place to effectively determine the Quality, Safety and Efficacy of a medicine under assessment.
By planning in advance the MHRA will be able to be more efficient and effective in the processing of your applications.
What is the process for the submission of information to the MHRA?
The steps are as follows:
- Step 1 – Download the MS Excel template spreadsheet
- Step 2 – Fill in with as much detail as possible/known
- Step 3 – Return to the MHRA via email to presubmission@mhra.gov.uk where the information will be treated sensitively and securely.
For all questions or queries, please email presubmission@mhra.gov.uk.
Medicines pipeline webinar
Here is a link to the Medicines pipeline webinar held by the MHRA on 26 September 2024.
Source: MHRA