The European Directorate for the Quality of Medicines & HealthCare EDQM is working on a project to modernise the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP).
About CEPs
The manufacturer of a substance will be able to provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a certificate of suitability (CEP) granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM)
The above is as described in the EU Directives on the Community code relating to medicinal products for human and veterinary use, the CHMP/CVMP guideline on Summary of Requirements for Active Substances and any relevant national regulation.
To apply for a certificate a manufacturer will submit a detailed dossier (refer to the relevant EDQM documents describing the content of the dossiers which may contain confidential data.
Further information is available here on the background and legal framework of CEPs.
The need to modernise the CEP
The EDQM is aware of the far-reaching effects that globalisation, the rise of digital technology and many other major regulatory and scientific developments have had on the pharmaceutical industry and competent authorities over the last three decades.
As the content and layout of the current Certificate of Suitability (CEP) remain substantially unchanged since the original created in 1992, the EDQM launched a project in an effort to modernise the CEP by designing a CEP of the future.
What is modernising the CEP expected to achieve?
The aim is to develop a modern CEP that will:
- better fit the current needs of stakeholders
- offer both greater transparency of the information conveyed and enhanced user-friendliness
- increase the acceptance of CEPs and ease the registration activities performed using CEPs
The EDQM methodology to design the CEP of the future
The first step was to gather feedback via a large public consultation using an online survey that was available on the EDQM website during 2020, which addressed three major topics:
- content,
- layout
- use/distribution of the CEP
Stakeholder suggestions from the public consultation on the content and layout/format of a future CEP
On content
The stakeholders made the following specific suggestions regarding the content of CEPs:
- To include more details on all sites involved in manufacturing in order to understand the supply chain and roles of each site.
- To be more transparent regarding the specifications of the substance covered by the CEP
- To include statements on the CEP with regard to risk assessment of nitrosamine and mutagenic impurities and also on the maximum daily dose and route of administration considered during assessment.
- To include information on physical treatments and related grades and controls (e.g. polymorphisms, PSD), or alternatively to include a statement that this aspect was not approved by the EDQM.
- For stability, stakeholders would appreciate the mandatory inclusion of a re-test period on the CEP, with the possibility of covering more climatic zones, together with statements on the need and absence of need for specific storage conditions.
On layout and format
On layout and format, the stakeholders made the following suggestions:
- A clear preference was expressed for an electronic CEP (e-CEP) rather than a paper document.
- The need to present the information mentioned on the CEP (additional tests, re-test period, elemental impurities, etc.) in tabular form for easy consultation was raised by many respondents.
In the survey, what were the aspects most frequently mentioned concerning the use of the CEP?
The aspects most frequently mentioned related to the use of the CEP were:
- To report the status of applications in the online “certification database” (e.g. requests for revision approved, change log with a general description of the changes included in the dossier and/or the CEP).
- To no longer issue revised CEPs for administrative changes (e.g. changes to names/addresses of companies).
- To no longer issue revised CEPs for changes not impacting the quality of the substance or not impacting the content of the CEP.
- There is still a need to check the authenticity of a CEP, either in the online “certification database” or through the introduction of a QR code.
- To revise the current declaration of access box (e.g. to have more space, to be aligned with the letter of access for ASMFs).
Identified areas of work based on the the survey, to design the CEP of the future
Based on all the comments and feedback received, the following five areas of work have been identified to design the “CEP of the future”:
- Review information to be reported on CEPs
- Reduce revisions of CEPs and facilitate handling of changes
- Enhance digital tools and public databases
- Implement a digitally signed electronic CEP.
- Use IT tools to facilitate the preparation and use of CEPs and also reference to CEPs in marketing applications
- Update EDQM databases to include more features and to disclose more information
- Foster information sharing between CEP holders & medicines manufacturers
- Disclose more information in the CEPs and in the online “certification database”.
- Identify ways to enforce and verify information sharing
- Train users on content and use of CEPs
Next steps leading to the rollout of a CEP of the future
| Timeline | Action |
|---|---|
| First half of 2022 | The design of the CEP of the future will be prepared. |
| Second half of 2022 | The proposals will be discussed with the relevant stakeholders and decision-making bodies. A large communication campaign will be initiated to explain the proposed changes. |
| Beginning of 2023 | The CEP of the future should be deployed and available to users. |
Source: EDQM website