EDQM Guidance: Reliance-Based and Fast-Track Assessment of CEP Applications

This guidance, published in March 2026 by the European Directorate for the Quality of Medicines & HealthCare (EDQM), introduces new approaches for accelerating the assessment of Certificates of Suitability (CEP) applications.

It focuses on two key pathways:

• Fast-track assessment

• Reliance-based assessment

Both approaches aim to improve regulatory efficiency, reduce delays, and ensure timely access to medicines.

CEP procedures are essential for demonstrating that a substance complies with the European Pharmacopoeia (Ph. Eur.) standards. However, delays in CEP approvals can contribute to medicine shortages, especially when active substances are not readily available.

Guidance on requesting fast-track assessment of CEP applications, revisions and renewals   

Fast-track assessment is designed to accelerate the evaluation of CEP applications, including new submissions, revisions, and renewals, particularly in situations where there is a risk of medicine shortages.

According to this guidance, eligibility for fast-track assessment is typically linked to public health needs. This may include cases where regulatory authorities such as the EMA or national agencies support the request, or where the substance is listed in an official shortage catalogue. In addition, applicants may request fast-track consideration if they can clearly demonstrate that accelerated assessment would provide significant benefit to patients.

Despite the accelerated timelines, the guidance emphasizes that all applications must still meet full EDQM requirements. The level of scientific and regulatory scrutiny remains unchanged, and acceptance of a fast-track request is ultimately at the discretion of the EDQM.

Applicants are expected to submit their request using the standard CEP process while clearly indicating the request for fast-track assessment in the cover letter, along with a strong justification supported by relevant evidence.

Guidance on requesting reliance-based assessment of CEP applications

Reliance-based assessment allows EDQM to streamline evaluation by leveraging prior approvals from trusted regulatory authorities. This approach aligns with the principles of Good Regulatory Practice (GRP), which aim to enhance efficiency, consistency, and transparency in regulatory decision-making.

As described in this guidance, reliance-based assessment is applicable when a substance has already been assessed and approved through mechanisms such as an ASMF or DMF in recognized regions, including the EU, UK, Canada, and others. In such cases, the CEP application can benefit from existing regulatory evaluations, provided that the manufacturing process remains unchanged and the submitted dossier is identical or only minimally updated.

The guidance also allows reliance in cases where an existing CEP is used within another CEP application. However, applicants must ensure that all submission requirements are met, including clearly requesting a reliance-based assessment in the cover letter and providing accurate reference details. Supporting assessment reports, when available, further strengthen the application.

Overall, these approaches reflect a shift toward more agile and collaborative regulatory systems that better respond to global healthcare needs.

📌 Reference

• For full details, refer to the official guidance (March 2026): Guidance on requesting reliance-based assessment of CEP applications

• Guidance on requesting fast-track assessment of CEP applications, revisions and renewals