The European Drug Master File (EDMF) can be used for new active substance, existing active substance described in the European Pharmacopoeia (EP) and existing active substance not described in the EP or the Pharmacopoeia of the member state, said, Des Mc Mahon, director of regulatory affairs, Pharmalink Consulting.
He was addressing a symposium on EU/US regulatory affairs environment - guidance for Asian companies wishing to license products in Europe and the USA, organised by the Pharmalink Consulting on May 15, 2007. The EDMF, which contains detailed scientific and administrative information, includes valuable intellectual property of the DMF holder. The DMF therefore be divided into applicant's part (AP) and restricted part (RP).
The AP contains the information, which is non-confidential, whereas RP contains the information that the EDMF holder regards as confidential. The CEP, which also known as COS, demonstrates the purity of a given substance produced by a given manufacturer. It guarantees that the quality of the substance is appropriate for use in medicines, and that all the impurities and potential contaminants related to the manufacturing process are satisfactorily controlled using the requirements of these monographs.
The suppliers of drug substance can prove this suitability by supplying CEP granted by the EQDM to the licensing authorities. The CEP then replaces the drug substance documents provided in the marketing authorization application in the EU. The CEP, which is accepted in all EU countries, is aimed at facilitating and simplifying exchanges between partners to ensure that the quality of substances is guaranteed, and that these substances comply with the EP, said, Des Mc Mahon.
The substances, which described in the EP, are active, excipients, herbal drugs and herbal preparations. He has also given detailed information about the various types of CEPs and the procedure for obtaining a CEP. The CEP requires one renewal after five years and the inspection lasts for three days. The certification benefits are single assessment, uniformity of assessment, replaces drug master file, savings of time and cost, updating monographs and revision of monographs, he added.
Talking on the application procedures Mc Mahon said, there are three kinds of application procedures for EU, centralized procedure, mutual recognition procedure and decentralized procedure. The centralized procedures can be applied for biotechnology products, new chemical entities for HIV, cancer, diabetes and neurodegenerative disorder products. Under the mutual recognition and decentralized procedure products are not mandated by centralized procedure, line extensions of MR registered product, MR products already licensed at application and generics.