The European Drug Master File (EDMF) procedure is one of the application ways for API importation to European market. The difference compared with COS application is that the EDMF can not be applied for independently by an API manufacturer, but by a drug agent or a final user who is applying for the product's marketing authorization at the same time.
Compared with COS application document, EDMF has an identical content including API manufacturing, in-process control, characterization, chemical properties, quality control, stability, and especially impurity study. Usually the EDMF document is divided into two parts: an open part (including information of chemical properties, quality control and Stability, etc.), and a secret part (including information of manufacturing process and in-process control, etc.).
A DMF is a document containing the information required to demonstrate that the quality of the active substance is adequately controlled by the specification proposed by the applicant. The applicant must, therefore, collaborate with the person submitting a separate DMF to ensure that all relevant information required is supplied. Furthermore it must be ensured that the applicant's part of DMF contains all information needed for the applicant to take full responsibility for the preparation, including the suitability of the active substance (as supplied) for the intended route of administration.
It is not a requirement to present information on the active substance in the form of a DMF. The information may also form part of the application for authorization to place a medicinal product on the market.
Three types of active substances may be described in a European DMF:
A. New active substances still covered by a patent, not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State.
B. Active substances off-patent, not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State.
C. Active substances described in the European Pharmacopoeia or in the pharmacopoeia of a Member State when prepared by a method liable to leave impurities not mentioned in the pharmacopoeial monograph and for which the monograph is inappropriate to adequately control their quality.
Our EDMF Service:
Our outstanding achievement in COS registration service proves that we are capable to compile high-quality EDMF for our clients. Till now, we have already compiled many EDMFs for our European clients, which are in the following procedure nowadays.
Our advantages in EDMF Service:
We have an expert team. They will work all along the procedure of the EDMF registration, until our client obtains the EDMF.
Our headquarters in France : Our Doctors of Pharmaceutics and senior experts will be in charge of the documents' examination, submission and tracing. They will also contact and discuss with the European officers directly.
Our Chengdu office: Our professional team is responsible to contact with Chinese factories and to compile the application files.
Laboratory center: we have established a laboratory in Sichuan University . Our experts of pharmaceutical analysis are in charge of the impurities experiments for EDMF registration.
Audit team: we have a professional QA team; they make third party GMP Audit to the API manufacturers.
The procedure of our EDMF service:
1) Sign a contract of EDMF agency service with the API manufacturer.
2) Provide the outline for compiling the application file to the client.
3) Introduce knowledge of EDMF and information about GMP from ICH to the client.
4) The client provides Chinese original documents and samples for experiments according to the outline for compiling the application file.
5) Examine whether the original document is good, guide the client to supply materials till the final Chinese version is finished.
6) Compile the English version of the application file.
7) According to the EDMF's requirements and the speciality of our client, we design an experiment plan and then accomplish the experimentation.
8) Finally examine the application file's quality with European experts, then confirm the final version.
The mode of our EDMF service: We are willing to establish a close relationship between clients and us, to offer special consulting service according to the actual situation and our client's special requirement. At the same time, thanks to our advanced project management, every project has its own manager, who is in charge of the client relationship and the internal coordination, so as to serve clients rapidly and effectively.
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