EDQM FAQs
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Answer:
According to Resolution AP-CSP (07)1, the procedure for ‘Certification Certification of Suitability to the Monographs of the European Pharmacopoeia’ Pharmacopoeia (CEPs) is intended for substances for which a monograph, either general or specific, individual monograph has been adopted by the European Pharmacopoeia Commission. The procedure does not apply for direct to gene products (ie.eg. proteins) , or products obtained from human tissues, vaccines and blood products and preparations.
In light of the discussions held at the European level concerning the classification of biological products, the products classified by the Coordination Group Co-ordination group for Mutual Recognition recognition and Decentralised Procedures procedures - Human (CMD(h)CMDh) as "other ‘other biological substances" substances’ are excluded from the scope of the CEP procedure. A list is available on the website of the Heads of Medicines Agencies website.
The reasoning behind this decision is that the characterisation and determination of biological substances require not only a combination of physico-chemical and biological testing, but also extensive knowledge of the production process and its control.
This means that the EDQM does not accept any new application applications for CEPs for these biological substances.
However, for historical reasons, there are a number of valid CEPs for such substances. These existing CEPs for biological substances may be included in the marketing authorisation application (MAA) but should not be used as replacement of to replace the relevant data in the corresponding sections of Module 3 . (cf procedural announcement related to submission (for more information, see the procedural announcement on Submission of full data on Module 3 of dossiers of biological substances of non-recombinant origin, included in the monthly report of the plenary meeting of CHMP, November 2009: EMEA EMEA/CHMP/745639/2009). CEP holders have to must provide their customers with full data to be included in Module 3 to their customers and MAH , and the marketing authorisation holder will then submit them in their MAA.
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