China-EU Seminar on quality related regulations of pharmaceutical products

China-EU Seminar on Quality Related Regulations on Pharmaceutical Products was held on July 11-12 in Beijing, which was jointly sponsored by Ministry of Commerce, State Food and Drug Administration (SFDA) and the Directorate-General for Health and Consumers (DG SANCO), and organized by China Chamber of Commerce of Medicines & Health Products Importers & Exporters (CCCMHPIE) and EU-China Trade Project (EUCTP) II.

Huang Rengang, Deputy Chief of Department of WTO Affairs, Li Maozhong, Deputy Inspector of Department of Registration of SFDA, Liu Zhanglin and Meng Dongping, Deputy Chairmen of CCCMHPIE, Maria Angeles Figuerola Santos, official from Drug Registration Division of DG SANCO, Doctor Guido Rasi, Executive Director of EMA, Susanne, Director General of EDQM, Gregory Perry, President of EGA, and officials from UK FDA Administration, Italian FDA Administration, and EUCTP took part in the Seminar, and 270 representatives from domestic and foreign pharmaceutical manufacturers also attended the Seminar. He Chunhong, Director of Technical Service Center of CCCMHPIE, and Doctor Guido Rasi, Executive Director of EMA, chaired the Seminar respectively.

Doctor Guido Rasi, Deputy Chief Huang Rengang and Deputy Inspector Li Maozhong delivered a speech respectively. Mr. Huang pointed out in his speech that, as the largest crude drug producer, China has made great contribution to the development of world pharmaceutical industry. The EU is the most important trading partner of China, and crude drug exports from China to the EU totaled US$5.48 billion in 2011, up by 22.4% year on year. The Chinese government and industrial organizations are dedicated to promoting the healthy development of China-EU medical trade, working out regulations and standards of international level, guiding regular pharmaceutical manufacturers to promote in overseas markets, and establishing credit management system for pharmaceutical manufacturers; the Seminar is of significance for the above aspects. Deputy Inspector Li Maozhong said in his speech that, it is important to strengthen discussion and communication about Chinese and EU supervision law on drugs, reinforce exchanges between the medical industries of the two sides, and set up mechanisms of regular meetings and communication. Through the platform of the Seminar, the two sides will strengthen the exchanges of advanced experience on GMP management and drug amendment, and he believed the wonderful speeches by China and EU experts will bring gains to all. At the Seminar, Guo Jingwu, section chief of Safety Supervision Department of SFDA, elaborated on China’s latest GMP regulations and the matters we should pay attention to.

At the two-day Seminar and training, experts expounded on such issues as the latest EU-GMP regulations, requirements of GMP inspection by EU member states at the third country, drug GMP in view of manufacturers, upgrading of European Pharmacopoeia, upgrading of Chinese Pharmacopoeia, EU’s new rules of crude drug import, and on-site inspection in view of member states. The Seminar carried out activities such as QA between manufactures and experts and discussion among the panel, so as to address problems of the manufacturers in their practical operation.

Source: Ministry of Commerce Website;


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