EDQM Releases New Edition of How to Read CEP

The Certification of suitability to the Monographs of the European Pharmacopoeia (CEP) is the passport for APIs to enter the EU market. On May 23rd, the European Directorate for the Quality of Medicines & HealthCare (EDQM) officially released the new "How to Read the CEP" guideline. From the structure of the document to the specific content, the new guideline has undergone a thorough revision, aiming to help the end users of CEP, especially formulation customers of API factories, obtain the required information from the certificate more efficiently and accurately.

Three CEP Formats

The new guideline clearly defines the three existing CEP formats currently in use and provides detailed explanations of their characteristics.

EDQM has introduced the latest electronic document format - CEP 2.0, which comes with an electronic signature and represents the digital future of CEP certificates.

The numbering system of CEP 2.0 consists of two parts:

• A fixed part, consisting of "CEP" plus the year and sequence number
• A variable part, representing the revision version number

To accommodate the transitional period, EDQM has also introduced a hybrid CEP, which combines the features of CEP 2.0 and the older versions. Its numbering system is exactly the same as that of CEP 2.0.

Before September 2023, API suppliers were familiar with the old CEP, which was in paper document format. Its numbering system consists of three parts: at the beginning there is a five-year update indicator "R1", followed by "CEP" and the fixed part of the year and sequence number, and finally the revision version number.

Upgrade Content Details

The new guidelines have also brought about many significant updates to the presentation of different types of CEP content. These updates are directly related to how customers understand CEP information provided by API suppliers.

• For Chemical CEP, newly launched CEP 2.0 will include complete quality standards for all testing items. This includes the detailed names of the testing items, strict limit requirements, and specific types of testing methods. This means that formulation customers only need to refer to CEP 2.0 to obtain the most comprehensive quality control information, without referring to other documents. In contrast, the previous version of CEP usually only listed testing items other than those in the pharmacopoeia monographs, resulting in a lack of complete information.
• For the herbal medicine CEP, CEP 2.0 requires that in the specific section of the certificate, the extraction solvents such as "60% v/v ethanol" and the extraction ratios be clearly listed. Additionally, to enhance transparency, CEP 2.0 will also provide a detailed list of all the excipients contained in the herbal medicine and their specific content information. These comprehensive data are of vital importance for the quality control of the herbal medicine, the traceability of the production process, and the formulation compatibility assessment by formulation customers.
• For TSE (Transmissible Spongiform Encephalopathy) CEP, CEP 2.0 requires more detailed disclosure of the types of animal tissues used as raw materials, such as "cow blood" or "cow tendon", along with corresponding production process information. Such detailed disclosure helps formulation customers evaluate potential TSE risks. The new guidelines stress the importance of conducting a comprehensive assessment of TSE risks, indicating that future reviews of TSE CEP will place greater emphasis on the completeness of risk identification and control.

Requirements for Production Site Information

The new guideline sets higher requirements for the disclosure of production site information. CEP 2.0 will list in detail the names and addresses of all production sites, as well as the key SPOR/OMS organization IDs and location IDs.

The SPOR/OMS database is an important source of information for the EU's drug regulatory authorities, and the consistency of its data is of the utmost importance. The guideline clearly states that if the detailed site address information listed in the CEP certificate file differs from the address registered in the SPOR/OMS database, the EDQM will use the description from the SPOR/OMS database in the CEP certificate.

CEP Authorization Letter

CEP 2.0 introduces an important new mechanism - Letter of Access, which will completely replace the Box of Access in the previous CEP.

This change means that the authorization process will become more formal and standardized. The CEP holder needs to fill out an independent authorization letter, clearly authorizing their clients to use this CEP in their drug registration application. The EDQM website also provides a standardized template for the authorization letter, greatly simplifying the operation process.

For formulation customers, they will receive an independent and legally binding authorization document instead of just a tick mark on the certificate. This helps to reduce potential ambiguity in authorizations and further simplifies the registration process for customers.

The release of the new "How to Read CEP" guideline by EDQM is an important step forward in the field of drug quality supervision. Proregulations deeply understands the significance of the new guideline for API suppliers and formulation enterprises, and is committed to providing comprehensive and one-stop services to help customers adapt to the new regulatory environment and increase the success rate of submissions. If you are interested in our services or need more details, please contact us.