A face-to-face Communication between the representatives of Chinese pharmaceutical industry and Heads of the Internationa Drug Regulatory Agencies
On the afternoon of November 21, 2014, a seminar on partnership for securing the global medicines supply chain sponsored by CFDA and hosted by CCCMHPIE was held in Beijing Chang Fu Gong Hotel during the 9th International Summit of Heads of Drug Regulatory Agencies. A face-to-face communication was undertaken on the seminar to explore how to integrate China’s pharmaceutical industry with the rest of the world. The participants included heads of drug safety authorities from China, America, European Union and the WHO, pharmaceutical firms like HISUN PHARM, NORTHEAST PHARM, LUYE PHARM, HENG RUI MEDICINE and representatives from 5 organizations including CCCMHPIE, China Quality Association for Pharmaceuticals (CQAP), China Pharmaceutical Industry Research and Development Association(PhIRDA), China Nonprescription Medicines Association(CNMA ) and China Pharmaceutical Industry Association(CPIA). The seminar was divided into two sections: joint lecture on global drug administration and dialogues on the safety of the global drug’s import & export. Dr. Margaret Hamburg, Commissioner of US FDA and Wu Zhen, Vice Minister of CFDA attended the seminar.
Yuan Lin, Director of International Cooperation Division of CFDA, hosted the “joint lecture on global drug administration” section. Dr.Margaret Hamburg, Commissioner of US FDA, Sabine Jülicher, Supervisor of Health Care Products Division in Directorate-General for Health and Consumers of European Commission and Lembit Rago, secretary of the Ministry of Drug Regulatory and Health & Science in the Basic Drugs Department, WHO, delivered speeches respectively.
Dr. Margaret Hamburg wished to strengthen the cooperation with China's drug safety authority so as to benefit the pharmaceutical industries and peoples of both countries. She said that two years ago US FDA revised the drug safety regulations to ensure a whole-process supervision of the entire life cycle of the medical products and the safety of drug use of the people from all over the world. One of these regulations was the enforcement of the GDUFA. Sabine Jülicher delivered a speech entitled “ EU’s New Import Regulations on the Drug’s Active Ingredients: Relevant Experience”, in which she highlighted the new trends of EU’s drug administration and the recent implementations of the Article 62 of EU. She said new regulations about the import of APIs of EU took effect on July 2, 2013, which strengthened the supervision of the APIs in EU and even the whole world. So far most APIs factories have owned written confirmations or have been listed in the “State Immunity list”. And there was no shortage of the APIs’ supply. She also gave special thanks to CFDA for their contributions for Chinese APIs export to Europe. Up to now CFDA had issued more than 900 written confirmations about the APIs’ export to Europe. Lembit Rago, in his speech, introduced WHO’s pre-certification program about medicine, vaccine, IVD and medical devices and so on and explained the effect of the pre-certification, the team structure of this program and the working process in detail. He also hoped that Chinese manufacturers take an active part in WHO’s pre-certification program and make contributions to the health of people in those low income countries.
Xu Ming, Vice Chairman of CCCMHPIE, hosted the “dialogues on the safety of the global drug’s import & export” section. Free talks about the GMP certification, on-site inspection, national registration, marketing authorization, quality control and technology were held among representatives from 20 enterprises including Sinopharm, HISUN PHARM , HENG RUI MEDICINE, LUYE Pharma, NORTH CHINA PHARMACEUTICAL CO,. LTD, NORTHEAST PHARM, GUILIN PHARMA and so on and Wang Gang, Assistant Director of CDFA China, Emer Cooker, Director of International Affaires Division of European Medicines Agency (EMEA), Sabine Jülicher, Supervisor of the Department of Health and Care Production in Health and Consumers of European Commission and Lembit Rago, secretary of the Ministry of Drug Regulatory and Health & Science in the Basic Drugs Department, WHO. Before this, CCCMHPIE have widely solicited opinions from enterprises and combined or classified questions posed by these enterprises.
At last, Li Guoqing, Director of Department of Drug and Cosmetics Registration (Department of TCMs and Ethno-Medicines Supervision) CFDA, made some closing remarks. He hoped that China's pharmaceutical industry take an active part in the international competition and strengthen communications with the International Drug Regulatory Agencies and meanwhile comply with the international rules and some relative national laws and regulations, which would help to build a good reputation and image in the world.
Recently, CCCMHIPE have provided vast services on registered consulting as well as laws and regulations training and so on, hoping to promote the internationalization of Chinese pharmaceutical firms and to push China's pharmaceutical industry to the world quicker and better.
Wu Zhen, Deputy Director of CFDA was present
Dr. Margaret Hamburg, Commissioner of US FDA, gave a speech
Communications between Chinese representatives and heads of the International Medicines Regulatory Agencies