Upgrading Manual of international registration and certification of drugs

Source: at the executive meeting held by the State Council on the first working day of the lunar new year on March 23, 2016 in pharmaceutical economic daily, special emphasis was placed on "supporting the international registration and certification of patented domestic original research drugs and brand generic drugs" The most important factor that restricts the export of Chinese drugs is the international registration of exported drugs So, how about the development of international registration and certification in China? What are the problems? What is the solution? Current situation 1 is at the bottom of the division of labor value chain In today's international trade, technical standards and market access regulations have become the most important factors affecting China's export of foreign trade products As a kind of special commodity, pharmaceutical products are the most advanced high-tech products, which are directly related to life health and quality of life At the same time of improving the level of domestic pharmaceutical products, countries have formulated strict management system and technical requirements for the registration of foreign drugs in their own markets Due to the characteristics of high technology and high standard, international drug trade has become one of the most frequently implemented trade areas In 2015, China's total exports of Chinese and Western patent medicines reached 3.46 billion US dollars, accounting for only 6.1% of China's pharmaceutical exports The most important factor restricting the export of drugs is the international registration of drugs In terms of internationalization, we seize the opportunity of gradient transfer of international pharmaceutical industry and gradually develop into the world's largest producer and exporter of APIs But generally speaking, we are still in the growth stage, and the main way to enter the international market is mainly trade In the four links of the value chain, we only have certain advantages in the production and manufacturing links, while we are at a disadvantage in the high profit rate R & D design, international marketing and brand operation links In the international division of labor and cooperation, we are at the bottom of the value chain, and we are still the raw material supplier in general The international registration of medicine has a long way to go At present, only a few enterprises in our country can break through the drug registration in foreign countries, especially in developed countries In the aspect of API export, most API manufacturers have not passed the foreign registration certification, and can only export as the upstream API of foreign manufacturers The added value of products is very low, and most of the profits are obtained by foreign distributors If registered as an API, the price of the product can generally be increased by more than 20% According to statistics, by the end of 2015, more than 100 enterprises in China had obtained 565 European Pharmacopoeia applicability certificates for APIs, accounting for only 12% of the valid certificates authorized by the European drug quality administration, which is inconsistent with the status of the world's largest API production and export country; in the same period, Indian enterprises held 1356 certificates, 2.4 times that of China There are 1013 active DMF documents in the United States, while India has 3165 (data at the end of 2014); there are more than 40 effective registrations of Chinese enterprises in Anda (generic drug application) in the United States, and India has been approved 144 in 2011 alone Only more than 50 enterprises have passed the verification or certification of the United States, Japan and the European Union, and only 16 have passed the WHO PQ certification, far lower than our neighbor India (356) The successful multinational companies in the world have gone through the process of accumulating conditions, asking for the way and gradually participating in the international operation However, the pharmaceutical production enterprises in China do not have the advantages in scale, capital, technology, talent and so on, and the risk of overseas investment is large Therefore, Chinese pharmaceutical enterprises should follow the strategy of "step by step, gradual upgrading" and take the route of "encircling the city by the countryside" In terms of international market development, it is advisable to start with low threshold markets such as Africa and ASEAN The reasons are as follows: first, the threshold of product and market access is low; second, Africa and ASEAN have a large population, especially Africa is short of medicine and medicine, with huge market potential; third, Africa's pharmaceutical industry has a weak foundation, the market demand is dominated by high value-added end products, with high return on product profits; fourth, it can borrow national pharmaceutical foreign aid projects and funds, and also draw lessons from some pharmaceutical enterprises The fifth is to participate in the pre certification work of the World Health Organization (who has special funds for training and guidance of participating enterprises), so as to improve the quality management level of enterprises For details, we can refer to the experience of multinational companies in China's development, start from brand operation and channel construction, and gradually expand the enterprise marketing team At the same time, we can make full use of Africa's rich resources, so that the enterprise operation extends to the upstream, and further improve the comprehensive competitiveness 2 cooperation to enhance the comprehensive strength of pharmaceutical internationalization involves many fields such as medicine, pharmacy, science and technology, culture, law, trade, finance, etc it is a process of extensive cooperation in science and technology, economy and trade, culture and even diplomacy, constantly improving the industrial level, providing safer and more effective products for the global pharmaceutical market, and serving human health The purpose of cooperation is to achieve common "evolution" and create new or greater value through cooperation with other enterprises It mainly includes the following three aspects: (1) increase cooperation in the field of R & D, cultivate R & D talents, and improve the level of R & D; (2) seize the opportunity of outsourcing, carry out cooperation in production and manufacturing, technical services, exercise the quality management team, and improve the quality management level and service ability; (3) Make full use of the international and domestic capital market, absorb advanced management experience and management mode through cooperation modes such as M & A, investment and financing, equity replacement, etc., and borrow the marketing channels of partners, so as to achieve the purpose of borrowing ships to go to sea In addition, we should give full play to the role of industrial organizations, take advantage of their platform advantages, and carry out multi-level cooperation and exchange in information exchange, regulatory training, property rights trading, technology transfer, etc 3 since 2006, under the guidance of the Ministry of Commerce, the chamber of Commerce of medical insurance has established the technical service center for import and export commodities (drug registration), issued the guidelines for registration of export drugs (2009 version and 2015 version), formulated and promoted the "technical guidelines for registration of export drugs" In order to help enterprises engaged in drug export business to master and adapt to the increasingly strict technical requirements of the international market, improve the ability of relevant enterprises to apply environmental protection, energy saving and other high-tech to improve the comprehensive benefits of foreign trade, realize independent innovation, so as to take the initiative in the fierce international competition, and improve the ability of cross industry, cross field and cross regional cooperation In addition, it cooperated with the European drug quality administration, the European drug review agency, the U.S Food and drug administration, Japan's Ministry of health and welfare and other institutions to carry out regulatory and registration certification training, and guided dozens of enterprises to carry out international registration Next, based on the existing work, the chamber will mobilize industry enterprises and local industrial park resources, jointly build a service platform, and cooperate with domestic institutions to build an international drug administration registration and guidance center At present, the sub centers of Portuguese, ASEAN market, European and American market, African market and traditional medicine registration have been established At present, the main bottleneck of the industry upgrading, especially the quality improvement, is the low quality system certification standard of pharmaceutical enterprises, which has not been recognized by Europe, America, Japan and other countries According to the author's survey, the current hardware equipment of Chinese pharmaceutical enterprises is not much different from that of developed countries, even better than that of Australian pharmaceutical enterprises However, in terms of enterprise quality management software, especially in the risk management of production process, document management, staff training, various verification and quality traceability systems, the gap is obvious As a special commodity, the quality requirements of medical products are particularly important from the perspective of people-oriented and maximum protection of people's drug safety Therefore, it is suggested that when revising the quality management standards, the country should further improve the standards and integrate with the certification system of developed countries such as Europe, America and Japan For the enterprises that take the lead in international competition, they can be supported from the policy level, such as differential pricing in bidding and purchasing, guiding the enterprises to actively upgrade the industry with the price mechanism, so as to improve the level of industrial quality management as a whole and reduce the risk of quality and safety accidents of pharmaceutical products Full text link: http://news.bioon.com/article/6680523.html