What is an active substance master file?
An active substance master file (ASMF) is a great way for an active substance manufacturer to retain confidential intellectual property on a substance, while still providing enough information to the marketing authorisation holder (MAH) to take full responsibility over their medicine. The format is based on the eCTD, and it is split into 2 parts – the restricted part (RP), which is sent directly to the authorities by the ASMF holder and contains information which the holder deems to be confidential, and the applicant’s part (AP), which is sent to the MAH for incorporation into the CTD.
Submission requirements
ASMFs can be submitted as part of a new marketing authorisation (MA) or through a variation application. Applicants should submit the AP of the ASMF as part of the eCTD dossier, together with a letter of access (LoA) issued by the ASMF holder.
When an ASMF procedure is to be used which relates to an ASMF that has not previously been submitted to the MHRA, the ASMF holder should submit a copy of the AP and the RP to the MHRA. This should be timed accordingly with the submission of the MA or variation, and arrive prior to (but not more than 1 month before) the submission of the MA/variation.
A good working relationship between the MAH and ASMF holder is therefore critical to organise these submissions. The submission should also be accompanied by:
- a completed submission letter and administrative details form
- any relevant letter of access
- the Quality Overall Summary for the AP and for the RP
- a curriculum vitae for the Expert
The complete ASMF only needs to be submitted once to register the ASMF with the MHRA.
Updating an ASMF
Any changes to the details within the ASMF need to be updated just as you would for an MA. The ASMF holder has a responsibility to notify each Applicant/MAH along with the MHRA that they are proposing to make changes to the ASMF. The impact should be assessed to review the actions that need to be taken e.g. does the MAH need to make a variation to the licence before the changes can be implemented?
Submission of a new ASMF and any update should be made by the ASMF holder using the MHRA Submissions Portal.
Summary
The advantages and disadvantages of using an ASMF need to be weighed up to decide if it is the correct path for your product / company. They can provide a reduced workload for the MAH initially, but do still require maintenance when they are updated. Other routes, such as CEPs (Certificates of Suitability), can provide an even further reduced workload route to market, these however are not always available.
If you would like to discuss how Fusion Pharma can support you with ASMFs, 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.
