EDQM restricts the Acceptance of Substances for New CEP Applications

A new selection procedure became effective on 2 January 2013 for substances submitted to the EDQM in the context of a new application for a Certificate of Suitability (CEP). EDQM's "Certification of Substance Division" points out in an official document that the application for a CEP implies substances for which the mode of preparation is in line with the requirements of the "Definition" Section of the Monograph of the European Pharmacopoeia. The following example gives some clarification: "if the Definition Section of the monograph states "Semi-synthetic product derived from a fermentation product" and the substance in question is manufactured by a purely synthetic process then a new application for a CEP will not be accepted".

Existing CEPs and on-going applications are not affected by this decision.

A revision of the CEP procedure was already made in December 2012. The EDQM has published revised guidelines for the suspension or withdrawal of a CEP or the closure of a CEP procedure. The document entitled "Suspension or Withdrawal of a Certificate of Suitability, Closure of an Application" contains the following information:

  • Process that leads to the closure of an on-going CEP application either upon request of the applicant of the CEP or by decision of the EDQM
  • Amendmends and clarifications in the scope and decision-making process
  • Consideration of cases of document falsification 
  • Changes to the procedure in case of a request for re-consideration of a decision taken by the EDQM (hearing)

You will find both documents on EDQM's Certification of Suitability News site.

Note: Get the latest information about the CEP procedure from a representative of EDQM at the ECA Conference "CTD, CEP and ASMF" on 19/20 March 2013 in Barcelona, Spain.

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