The European Directorate for the Quality of Medicines & HealthCare (EDQM) have published two new guidance documents detailing procedures for both reliance-based and fast-track assessments of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) applications which are effective from 01 March 2026.
The procedures share a common goal of ‘facilitating and accelerating access to quality assured and safe active substances whilst ensuring regulatory alignment’.
Reliance-based assessment uses prior regulatory approval of an Active Substance Master File (ASMF)/Drug Master File (DMF) from countries or organisations which have equivalent regulatory requirements to the EDQM as the basis of the assessment. The aim is to expedite and harmonise the assessment of new CEP applications and reduce administrative burden on the assessors.
This means that CEP applications where an ASMF/DMF has already been assessed and approved after October 2012 within the European Union, European Economic Area, Switzerland, United Kingdom, Australia, Canada or the WHO prequalification programme are eligible for reliance-based assessment. The EDQM affords a higher level of reliance to prior regulatory approval received after January 2016 based on a collaborative approval which involved multiple competent authorities (such as the centralised or decentralised procedures) as compliance with significant guidelines (e.g., ICH M7) would have been assessed. In contrast, a lower level of reliance is afforded for prior regulatory approval solely based on a national procedure or that obtained between October 2012 and January 2016, as specific European requirements and ICH M7 would not always have been taken into consideration during the assessment.
Partial reliance-based assessment can also be requested for the use of approved, valid CEPs within the application covering an intermediate in the manufacturing process of the active substance.
Fast-track assessment addresses recognised shortages of certain active substances in Europe and when eligible provides a prioritised assessment for new CEP applications, revisions and renewals to help minimise the impact of any such shortage.
To use either procedure, a request for prioritised and/or reliance-based assessment must be made and justified in the cover letter of the application. For reliance-based assessments, the approved ASMF/DMF number should be stated in the application form or referenced CEP included in the dossier.
Both procedures aim to substantially shorten approval timelines. Currently, new CEP applications are approved on average between 15 to 22 months after submission, however, the formalised procedures look to shorten the approval timelines to between 4 to 6 months. One point to note is that this is a two-way process with the timeline for responses to requests for additional information also being shortened, meaning an applicant will have less time to respond to questions than within a standard procedure.
The EDQM are keen to stress that both reliance-based and prioritised assessments should not be seen as a lighter touch, therefore, any application submitted under these procedures will undergo the same level of regulatory evaluation as a standard application. As such, the submitted CEP dossier should be of a sufficiently high quality to ensure full conformance with the requirements of the EDQM including compliance with the relevant European Pharmacopoeia monograph and applicable regulatory guidelines and policies. For reliance-based assessments, the dossier should be essentially the same as that approved for the ASMF/DMF with minor revisions acceptable. In addition, if any in-house methods are approved in the ASMF/DMF dossier and retained in the application, equivalence to the methods of the relevant monograph of the European Pharmacopeia must be demonstrated in the CEP application.
Summary
The new EDQM guidance represents a shift toward more efficient regulatory processes by giving significant weight to assessments performed by other regulatory authorities and by prioritising critical applications to manage medicine shortages. The new procedures offer significant reduction in time to approval but do not reduce the EDQM’s regulatory expectations for the application content.
How can S-cubed help you?
S-cubed can provide support throughout the full life cycle of the CEP procedure; from authoring of the dossier, preparation and submission of the application, responses to EDQM questions through to revisions and renewals of the certificate.
Any Questions?
If you have any questions on this topic or require support with your CEP application, please don’t hesitate to get in touch. You can contact us here, via email (info@s-cubed.co.uk), and telephone (S-cubed Ltd: +44 1235 77 22 60).