¡¡¡¡The Training Session on EU-China Pharmacopeia and Quality Standard 2014, co-hosted by CCCMHPIE and EU-China Trade Project (II), was held on December 3-4,2014 in Beijing.
¡¡¡¡Mr. Xu Ming, Vice President of CCCMHPIE and Mr. Patrick Deboyser, Minister Counsellor of DG SANCO attended the meeting gave opening remarks respectively. Lots of industry experts and hundreds of business representatives home and abroad from CHP, EDQM, Healthcare products Regulatory Agency (HPRA) Ireland, EFPIA and Institute of Chinese Materia Medica China Academy of Chinese Medical Sciences and so on attended this training session, which is chaired by MS. He Chunhong from Technical Service Center of CCCMHPIE.
¡¡¡¡Mr. Patrick Deboyser said in his speech that only by the legislation and coordination of the Pharmacopeia can we promote the integration of EU pharmaceutical affairs. The European Pharmacopoeia Convention was essential for strengthening the coordination among the EU countries and it could also ensure a high-quality of pharmaceuticals at EU level and public health. In recent years the corporation between China and EU has become more and more frequent. Lately China-EU Annual Bilateral Meeting powered the corporation once more. DG SANCO would love to join the corporation, working together to standardize the coordination and integration.
¡¡¡¡Xu Ming said in his speech that during these years China’s trade in Healthcare Sector increased rapidly and the pace of Chinese enterprises going global quickened either. Now about 40 products were applying ANDAs in the USA and about 50 companies have GMPs of USA, EU.WHO and Japan. Nevertheless, Chinese companies were still in the early stage of internationalization. It was still not an easy task to acquire certifications from US, EU, WHO and to get products successfully marketed. CCCMHPIE had been long committed to promoting Chinese companies meeting the international standards and expected this training session a good learning opportunity for both companies and experts to communicate with each other.
¡¡¡¡Dr. Susanne Keitel, Director of the European Directorate for the Quality of Medicines & Healthcare (EDQM), gave a detailed introduction of Europe’s medicine quality management in the European Regulatory Framework and current “Hot Topics” and Priorities for the European Pharmacopoeia; Ms. Cathie Vielle, Head of European Pharmacopoeia Department European Directorate for the Quality of Medicines & Healthcare (EDQM), interpreted the revisions and future development of the European Pharmacopoeia and the updates on European Pharmacopeia THMP Monographs. Dr. Mike Morris, Director of Scientific Affairs Health Products Regulatory Authority, introduced the quality control of chemicals in European Pharmacopeia (identification, impurity control, assays, genotoxic, biological test, excipients, validation for production, etc) and shared experience on quality control and product registration in EU. Dr. Daniel Song from EFPIA interpreted the European and Chinese Pharmacopeias from an industry perspective. And Mr. Bian Baolin, Deputy Director of Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, described the quality control of THMP in CP (TCM inclusive).
¡¡¡¡Of all these presentations, the speech delivered by Mr. Zhang Wei, Secretary General of Chinese Pharmacopoeia Commission (ChPC), received active responses from the participating representatives. Zhang Wei introduced the Chinese Pharmacopoeia-Working procedures, work program and hot issues. It was said that the species recorded in the Chinese Pharmacopeia had achieved 5,600, a 26 percent increase; additionally, the Chinese Pharmacopeia (2015 edition ) , more systematic and more standardized, helped to establish a sound medicine standardized system and perfected those defect means which led to a better control of safety and validity.
¡¡¡¡The training session delivered news about the latest development of Chinese Pharmacopeia and European Pharmacopeia and interpreted policies from different perspectives: the government, the industry and the enterprises, which provided lots of information for the corporation of drug administration and market access of enterprises. Meanwhile, the Questions and Discussion section also provided a platform for the representatives and experts to have full communications. In conclusion, it was a complete success.
 

 

Mr. Xu Ming, Vice President of CCCMHPIE delivered a speech