European and American officials accompanied the inspection
1）EDQM：European Directory for the Quality of Medicine & Healthcare
European Agency for the Quality of Medicines
Agencies primarily responsible for the quality assessment of APIs, including:
◆ Establishment of standards; publication of European Pharmacopoeia and establishment of European Pharmacopoeia standards.
Quality control of pharmaceutical products; Pharmacopoeia suitability certificate of API.
◆ Management of blood transfusion and organ transplantation;
2）EMA: European Medicines Agency
European Medicines Authority
Mainly responsible for the approval of the market license of the preparation
Ways to obtain EU permission
◆ Application for CEP (European Pharmacopoeia Adaptability Certificate) Certificate
◆ EDMF/ASMF program, which becomes EU-listed
Raw material supplier of pharmaceutical preparations
In order to obtain the GMP certification inspection of the EU or its member states, one of the above procedures must be selected.
| ◆ CEP documents are reviewed by EDQM. Once the certificate is obtained, it can be recognized in many European countries, including Canada, South Korea and other non-European countries. Only copies are required. | ◆ The EDMF/ASMF procedure must provide separate documents to the competent authorities of the relevant country, different competent authorities will review the documents and ask questions that are not needed, the holder of EDQM needs to answer questions from the competent authorities of different countries, the procedure is complex and difficult to operate. |
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
Sweep to identify concerns:
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