GovWire

Overview

The Medicines and Healthcare products Regulatory Agency (MHRA) are requesting that current or potential medicines Marketing Authorisation Holders (MAH) provide information on planned or potential future submissions to the MHRA. This page holds information detailing how, what, and why we require this data to be submitted.

Having advanced knowledge of expected submissions of all types, and requests for advice is key for the MHRA to effectively deliver our services to the highest quality and to be predictable with our assessment and advice timelines. As well as benefits for industry timeframes, patient access and system colleagues.

The template spreadsheet (MS Excel) at the bottom of this page can be downloaded, filled in with as much information as possible and returned to the MHRA at presubmission@mhra.gov.uk where the information will be treated sensitively and securely.

Information to be submitted

The spreadsheet template contains a number of fields to be filled in about expected and possible submission of applications and variations to the MHRA. It is intended that we build a picture of all incoming applications and new indications up to 5 years in advance of submission.

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 we are asking data from

The MHRA treats all submissions as important as each other, therefore all current or prospective Marketing Authorisation Holders are requested to contribute to our pipeline planning efforts. This is true if the company has 1 or 100 products in your pipeline.

We regularly collect data from UK Pharmascan to compare with the pipeline information, for those companies where they require a HTA assessment, we combine this information to ensure completeness and accuracy.

What the MHRA does with this information

When the MHRA receives the data, we process 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. We acknowledge 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.

The benefits to you for providing this information

The medicines pipeline data collected informs the agency of short to medium term demand on our services. This allows us to:

• Efficiently and accurately resource processing and assessment teams and ensure 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 we have appropriate expertise and regulations in place to effectively determine the Quality, Safety and Efficacy of a medicine on assessment.

By planning in advance we will be able to be more efficient and effective in the processing of your applications.

The process and template

• 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

For all questions or queries, please email presubmission@mhra.gov.uk.