The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published guidelines on how Certification of Suitability (CEP) holders or prospective applicants can request reliance-based or fast-track assessments.

Both pathways offer accelerated assessments of new applications for chemical purity while maintaining the regulatory diligence and rigor of standard CEP reviews. The circumstances in which the pathways can be used are different, with EDQM opening the reliance-based route to companies with certain regulatory approvals and creating the fast-track mechanism to address medicine shortages.
 
The reliance pathway is open to applicants with Active Substance Master Files (ASMFs) or Drug Master Files (DMFs) that have been assessed and accepted in the EU, European Economic Area, Switzerland, UK, Australia, or Canada since October 2012. The manufacturing process must be the same for the existing and requested approvals. EDQM expects the CEP dossier to be identical to the ASMF or DMF dossier, although it may accept minor updates to the original file.
 
Applicants may be eligible for a fast-track review when EMA or a national regulator has asked EDQM to help address an active substance or excipient shortage. EDQM will also consider fast-tracking the review of active substances that EMA lists as being subject to an ongoing shortage. The directorate will refuse requests for fast-track assessment based solely on commercial grounds.
 
On a case-by-case basis, EDQM will consider fast-tracking requests from prospective CEP holders that can clearly show an accelerated review would deliver significant benefit to patients or align with the objectives of the EU Critical Medicines Act. EDQM will consider the criticality, therapeutic indication, and availability of the active substance when assessing the impact of a fast-track review on patients.
 
EDQM has established the same timelines for reliance-based and fast-track reviews. The directorate will complete the initial evaluation within 46 working days, after which the applicant will have 30 calendar days to respond. EDQM has 23 working days to complete its subsequent evaluation. Initial assessments take up to 115 working days under the standard procedure.    [EDQM]