Back Regulatory Reliance and Fast track assessment in the CEP procedure

EDQM Strasbourg, France 09/10/2025
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Regulatory Reliance and Fast track assessment in the CEP procedure

According to the World Health Organization (WHO), “Good reliance practices are anchored in overall good regulatory practices (GRP), which provide a means for establishing sound, affordable, effective regulation of medical products as an important part of health system strengthening. If implemented effectively, GRP can result in consistent regulatory processes, sound regulatory decision-making, increased efficiency of regulatory systems and better public health outcomes” 1.

An increasing number of regulatory authorities are now using or piloting the use of reliance principles in the assessment of medicines. The EDQM also supports the use of reliance during the treatment of applications for Certificates of Suitability (CEP) and will continue to do so, with a focus on new CEP applications and sister files. Using reliance-based assessments, the EDQM endeavours to benefit patients, industry and authorities, by facilitating and accelerating access to quality assured, effective and safe active substances while saving resources and ensuring regulatory alignment.

Currently, reliance-based assessments are centred on applicants for CEP having declared the availability of a suitable Active Substance Master File (ASMF)/Drug Master File (DMF) for their substance via Section 3 of the application form, however, additional avenues for reliance-based assessments are also under investigation by EDQM. Applicants for CEPs are therefore encouraged to provide relevant information in their application form.

The EDQM also wishes to inform CEP applicants that, in alignment with the principles of the EU Critical Medicines Act 2 and to contribute to co-ordinated actions to mitigate risks of shortages of pharmaceutical substances, some CEP applications or their revisions may undergo fast-track treatment in justified situations. The EDQM is putting in place a process through which CEP applicants may submit justified requests for fast-tracked treatment of their CEP application.

Further details on the evolution of both the reliance-based assessment and fast-track processes will be published on the EDQM website in the coming months.

  1. Good reliance practices in the regulation of medical products: high level principles and considerations. Annex 10, WHO Technical Report Series, No.1033, 2021.
  2. European Commission: Critical Medicines Act