Medical network - on July 13, July 12, jointly organized by the state food and drug supervision administration and the ministry of commerce of drug quality management seminar "in 2017 developing countries (ministry)" held in Beijing. State food and drug supervision and administration bureau deputy director wu to attend the opening ceremony and delivered a speech.
Wu pointed out that after years of development, China has become the world's second largest pharmaceutical consumption market, the first largest exporter of active pharmaceutical ingredients. China has nearly 5000 raw materials and preparations enterprises, pharmaceutical manufacturing year advocate business wu income over 2.5 trillion yuan (RMB), as one of the few than GDP growth industry; Among them, the nearly 50 enterprises through Europe and the United States certification or inspection, medical manufactured goods exports over 13.5 billion us dollars, it shows that China's pharmaceutical industry has for the rest of the world's ability to provide safe and reliable pharmaceutical products.
At present, China's pharmaceutical industry is for global innovation drug development contributes own strength, in the global disease prevention and health care field plays a positive role. In 2015, professor tu and she discovered artemisinin was awarded the Nobel Prize in physiology or medicine. As the world health organization recommends a line of antimalarial drugs, artemisinin in the world, especially in developing countries to save the lives of millions of people, called the discovery "in the second half of the 20th century's greatest medical innovation". Guilin pharmaceutical co., LTD in China and kunming group and other production enterprises, actively to the international certification, greatly improving the artemisinin-based antimalarial drugs in areas prone to malaria especially the accessibility of the African market.
Today's society, the rapid development of new technologies, new methods, puts forward higher requirements on drug scientific supervision. The Chinese government is also in constant exploration, and actively with international drug regulatory system. In 2011, the Chinese vaccine regulatory system recognised by the WHO, up to now, made by hualan bio-engineering and its generated in all company produces the vaccine has passed the certification, WHO is entering the international market smoothly. On June 19, 2017, officially joined the state food and drug supervision and management of the administration, for example (international meeting with drug registration technology). This means that China's drug regulators, the pharmaceutical industry and r&d institutions will gradually transformation and implementation of international standards and guidelines, and will actively participate in setting the rules, promoting international innovation drugs to enter the Chinese market as early as possible, meet the demand of clinical medication, at the same time urged China's pharmaceutical industry innovation capacity and international competitiveness, promote China's pharmaceutical products in the world.
Wu also pointed out that "the drug safety was the event of human life", its core is the drug quality. The Chinese government attaches great importance to drug quality and safety, and always dedicated to explore suitable for China's national conditions, in line with international standards of drug regulatory system, and establish a relatively perfect system of administrative regulations and technical standards, including mainly the pharmaceutical administration law of the People's Republic of China drug administrative rules and regulations system, with the pharmacopoeia of the People's Republic of China "as the core system of pharmaceutical standards. In 2016, the national drug supervision administration of China overseas examination on the imported drugs, covering 19 developed countries and developing countries, involving 15 varieties, in the field of strengthen the drug safety supervision of international cooperation has achieved significant results.
Drug registration system is the foundation of healthy development of the pharmaceutical industry. Since this year, China's drug supervision administration for examination and approval of the drug approval system reform has taken many measures. Us to determine the definition and classification of new drug has been clear about the generic drugs must be consistent with the original drug quality standard of review, the establishment of a dominated by clinical efficacy of drug approval system, on the basis of the emphasis on medicine, technology, quality, focus on the drug clinical trial results, to ensure the clinical curative effect of listed drugs. This a series of New Deal has achieved great success, to speed up the drug approval for examination and approval. In order to further mobilize the enthusiasm of drug research and development institutions and scientific research personnel development of new drugs, the Chinese government in 10 provinces (municipalities) was carried out by drug marketing authorisation holder system pilot, pilot projects are well under way.
Wu said the drug post-marketing surveillance is the important content of drug safety regulation, and pharmacovigilance system is indispensable to prevent drug risks the scientific method. With the rising of the Chinese drug regulatory level, technical standards in line with international standards gradually, pharmacovigilance working also got great progress, is moving towards the advancing of scientific, standardization and legalization.
It is understood that the seminar theme is: win-win cooperation, seek common development; Open communication, share to build. Workshop through lectures and exchange interaction, access to the local food and drug supervision bureau, field trips, pharmaceutical production enterprises, make relevant national drug regulatory officials insight into China's drug regulatory system construction and Chinese drug approval for examination and approval system reform, etc. From Cambodia, the Czech republic, Mauritius, panama, seychelles, south Sudan, Zambia, Tanzania and Uganda nine countries of the ministry of health, national drug regulatory agencies of 32, bureaus officials attended the seminar.
At the same time, wu to attend the seminar assembled at present the 2015 edition of China pharmacopoeia (English version). Uganda, vice minister of health, the Russian federation and health administration, the Czech republic food and drug administration, Tanzania, United Nations programme on HIV/AIDS (unaids), the UN project services department, the central African funds, the gates foundation of guests were invited to attend the opening ceremony and delivered a speech.
Before the seminar, wu met with visiting Russian federal health supervision bureau director jose irina lashko a line, the two sides will strengthen drug medical device regulatory exchanges and cooperation and so on are discussed.
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