I still vividly remember my days at the MHRA – reviewing countless dossiers, applications, and cover letters under tight timelines.
Sifting through complex justifications, tables, and supporting data to reach a final decision was not always easy. Each application was scrutinised to ensure that public health was protected, while also enabling Marketing Authorisation Holders (MAHs) to advance their pipelines and meet patient needs, with no unjustified or unsupported data approved.
Regulators are often required to assess large volumes of data within tight timelines, while maintaining high quality standards and meeting legislative targets.
Failure to meet these expectations can impact both the regulator’s reputation and public trust.
Having worked on both sides, I now understand what I look for in a dossier and what made my work easier or harder at the time.
Some companies produced excellent dossiers, structuring everything neatly and succinctly without missing important information. Others (naming no names!) submitted cluttered dossiers, overloaded with unnecessary supporting documents while omitting key information. Common issues included insufficient justification, unsupported claims, and incorrect categorisation for variations.
A robust and streamlined dossier makes a regulator’s work life easier, leading to a faster decision, less questions and ultimately, faster access for patients!
By preparing clear and well-structured dossiers, applicants can help streamline MHRA review and assessment, benefiting both sides by reducing rework for MAHs and freeing up MHRA regulatory capacity to support other applications and broader public health priorities
Tips on how to streamline your dossier and make it easier for the MHRA to review/assess applications, reducing questions?
- Cover letter/annexes should not be too lengthy but clearly structured with the main information at the top (ideally in a table), including the required statements and listing what has been included in the dossier. Less is more when it comes to ease of review/assessment and repeating the same information several times just slows down the review process. For example, in some cases the MHRA prefers a tabulated summary of all manufacturing site details in the cover letter.
- Including a lot of unnecessary supporting documentation in any part of the dossier “just in case” does not help the assessment process – it makes it harder to locate the supporting data, and can obscure key information within a large volume of files. This can lead to the MHRA requesting information that was already included in the dossier, simply because it is not easy to find. Include just what is required to support the application and leave out any additional files such as e.g. tracked SmPC fragments (if full tracked SmPC was already included) or files required by other regulatory authorities like EMA, FDA (but not required by MHRA).
- Including too little information or lack of justification for proposed changes (in case of variations) will lead to an RFI or a VCR (at best). When the dossier is prepared, ensure the appropriate justification has been included where necessary to avoid lengthy RFIs or VCRs from the MHRA, seeking clarification and confirming position. Not including enough is just as frustrating for regulators, who sometimes go repeatedly through the full dossier to see if it was included somewhere else before sending an RFI.
- Including out of scope changes (for variations) will lead to additional questions or an invalidation. As an example, when trying to include non-editorial changes as editorial. without classifying them accordingly, this will lead to additional questions or even invalidation or refusal of the application. Any additional changes should be justified and supported – regulators would often wonder why this was included and not explained.
- If important files are provided at a later stage of the procedure (e.g. mock-ups) or post-procedure, relevant commitment statements should be included and justified. If you leave the MHRA to guess why something was not included, then an RFI or a VCR is guaranteed, which will delay the approval timelines. As an example, if you intend to supply the mock-ups towards the end of the procedure, this should be clearly stated on the cover letter or a commitment statement should be provided to avoid the MHRA granting the application with texts only, requiring another post-approval submission, and potentially delaying the product launch.
- Placing files in the wrong location of the dossier/naming files incorrectly or generically leads to confusion and MHRA may request the same files again. If the regulator cannot find the supporting documents in the relevant sections of the dossier, they will ultimately request them again via an RFI or VCR, and this will delay the overall approval timelines.
- Not having bookmarks throughout the dossier makes it challenging to navigate. This is particularly important for Modules 4 and 5, containing numerous studies and reports. Always ensure to add contents pages, hyperlinks or bookmarks where possible to support timely assessment.
When preparing your dossier, always critically evaluate how easy it is to find the essential files, how structured the dossier is and if you were on the other side – would you approve this submission?
If you strive to deliver an excellent dossier and would like to discuss how we can support you in streamlining and strengthening your submission, while ensuring it meets the MHRA requirements, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.
