The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published two new guidelines describing how CEP holders or prospective applicants can request reliance-based or fast-track assessment of their dossiers.

The first guideline, “Guidance on requesting reliance-based assessment of CEP applications”,  details when and how prospective CEP applicants may benefit from expedited and harmonised assessment of their CEP application based on prior regulatory approval within the European Union, EEA, Switzerland, the UK, Australia, Canada or the WHO pre-qualification programme.

The second guideline, “Guidance on requesting fast-track assessment of CEP applications, revisions and renewals” , provides information on how regulatory authorities, as well as prospective CEP applicants and holders, can request fast-track assessment of dossiers to address recognised shortages in Europe and/or where fast-track assessment aligns with the objectives of the EU Critical Medicines Act.

CEP applicants and holders are advised that both reliance-based and fast-track assessments conducted by the EDQM are still subject to the same regulatory diligence and rigour as any standard CEP application.

See also:

• Changes to e-submission requirements for CEP applications – Reminder
• EDQM e-learning catalogue – A wealth of knowledge at your fingertips
• Certification - Background & Legal Framework