Yin Li said that the new version of GMP certification will not be delayed and will not be lowered.


Release time:

2012-12-18

On December 13, the national on-the-spot meeting to promote the new revision of drug production quality management standards was held in Taiyuan, Shanxi Province. Yin Li, director of the State Food and Drug Administration, pointed out at the meeting that 2013 is a key year and a crucial year for the implementation of the newly revised GMP. Yin Li demanded that drug regulatory departments at all levels should strictly check in accordance with the law, adhere to the standards not to be lowered, strive to achieve uniform distribution of certification progress, unified grasp of certification standards, and fair and just certification work. All parts of the country have the same standards, the same requirements and the same yardstick, and it is never allowed to have different inspection and certification work. Time does not extend the standard does not reduce.According to statistics, there are 1319 aseptic drug manufacturers with 4462 production lines; 3708 non-aseptic drug manufacturers with 18923 production lines. As of November 30, 2012, a total of 597 enterprises nationwide have obtained 699 GMP certificates. Among them, 147 enterprises have obtained 170 sterile drug certificates issued by the State Administration, 485 enterprises have obtained 529 non sterile drug certificates issued by provincial bureaus, and 35 enterprises have obtained two types of certificates respectively. According to the statistics of drug categories of sterile drug manufacturers, 55 enterprises with small volume injection have obtained 58 certificates, 45 enterprises with large volume injection have obtained 50 certificates, 62 enterprises with powder injection have obtained 70 certificates, and 15 enterprises with blood products and vaccines have obtained 18 certificates. According to provincial statistics, the top five are Guangdong, Jiangsu, Shandong, Henan and Shanghai. The top five non sterile drug manufacturers are Jiangsu, Zhejiang, Guangdong, Shandong and Hubei. According to regulations, the production of sterile drugs such as blood products, vaccines, and injections should meet the newly revised GMP requirements before December 31, 2013, otherwise production cannot continue.Yin Li said that from the bottom-up situation, all or part of the workshops of 11% of sterile drug manufacturers across the country have passed the newly revised drug GMP certification, which is still far from the expected goal and the task is very arduous. Li Guoqing, director of the Safety Supervision Department of the State Food and Drug Administration, said that the implementation of the newly revised GMP is a deployment made by the State Council. As the competent department, we must perform our duties as required. In the next step, measures will be taken to eliminate the wait-and-see mentality of all parties and continue to do a good job in promoting the work in an in-depth and down-to-earth manner. On the basis of the thorough investigation in the first half of this year, enterprises with the conditions are encouraged to apply for and certify as early as possible, so as to alleviate the pressure and possible adverse effects of getting together at the end of the year. Take measures such as "grasping both ends and promoting the middle" to actively promote the implementation of the new version of GMP.Shanxi model surfacedWu Zhen, deputy director of the State Food and Drug Administration, pointed out at the meeting that the implementation of the newly revised drug GMP is an important guarantee for improving the quality of my country's drugs, and it is also of great significance for promoting enterprises to become bigger and stronger. It is reported that since the promulgation and implementation of the newly revised drug GMP for more than a year, various localities have carried out in-depth mobilization, deployment, publicity and implementation, and many provinces and cities have taken measures to local conditions and have made experiences and practices worthy of serious summary. For example, the meeting is located in Shanxi Province. It is reported that there are currently 118 pharmaceutical companies in Shanxi Province, and the number of pharmaceutical companies and the scale of the industry are not prominent in the country. Zhao Guangguo, director of the Shanxi Food and Drug Administration, analyzed, "From the perspective of the industry and certification in our province, there are three outstanding problems: first, the scale of the enterprise is small and the total industry is small; second, the homogeneity is serious. There are few advantageous varieties; third, the development level is low and the certification pressure is high. The total sales of production enterprises in the province is only more than 10 billion, accounting for less than 1% of the country's total. Only 22 have sales revenue exceeding 100 million yuan, less than 20% of the total number of enterprises, only 5 have sales revenue exceeding 0.5 billion yuan, and only 3 have sales revenue exceeding 1 billion yuan. Family. There are many general medicines, many low-end varieties, the same product categories, the same structure, fewer superior products, fewer specialty products, fewer high-end products, weak corporate innovation capabilities, low profitability, poor basic conditions, and 70% of corporate sales revenue is less than 50 million yuan." "The main task for Shanxi pharmaceutical industry to achieve transformation and leapfrog development in the next three years is to implement the newly revised drug GMP certification. The completion of the newly revised drug GMP certification on schedule is the basis for the survival of enterprises, the prerequisite for transformation and leapfrog development, and a solid foundation and an important way for transformation and leapfrog development." Zhao Guangguo said.In view of this situation, Shanxi Province has taken a series of measures to promote the transformation and upgrading of the pharmaceutical industry. It is reported that under the guidance and promotion of Shanxi Province, 21 enterprises such as Yabao Pharmaceutical (600351, stock bar) have begun to carry out resource integration, merger and reorganization. According to Zhao Guangguo, before the promotion meeting, in order to effectively promote the integration of resources, a thorough investigation was conducted on the cooperation intention of enterprises, and 53 enterprises put forward the intention of resource integration, of which 20 proposed merger intention, 20 proposed transfer intention, and 13 proposed cooperation intention. Through the negotiation of mature projects, an agreement will be signed at this meeting. "In the future, we will take external introduction and internal connection as a strategic measure to implement upgrading and transformation, improve industrial concentration and competitiveness, and vigorously promote it." In addition, in response to the constraints of enterprise upgrading certification, insufficient investment in enterprise transformation, and shortage of funds, Shanxi Province actively communicated and negotiated with financial institutions to seek cooperation support, and selected Bank of Communications (601328, stock bar) and Minsheng Bank (600016, stock bar) As the main strategic partners to promote the development of the pharmaceutical industry, and signed a strategic cooperation framework agreement with the two banks at this meeting. It is reported that the two banks have clearly put forward a series of preferential measures to support the development of pharmaceutical enterprises. On the basis of early communication with enterprises, the on-site meeting also specially arranged for banks and enterprises to further negotiate and sign cooperation agreements on the spot. "We also sincerely hope that Bank of Communications and Minsheng Bank will regard the transformation and upgrading of pharmaceutical enterprises as a key investment project, and the transformation and development of the pharmaceutical industry as an important investment area, so as to achieve win-win development between pharmaceutical enterprises and banks." Zhao Guangguo said. It is reported that at present, some advantageous products in Shanxi Province occupy a dominant position in the national market, with potassium clavulanate selling first in the country, medicinal hollow capsules selling first in the country, safflower injection selling first in the country, oxytetracycline selling second in the country, chemical raw material drug intermediates such as 6APA and 7ACA selling third in the country, and compound Kushen injection, Ding Guier umbilical patch, ginkingdamo injection and didamo injection and Shuxuening injection occupying a large market share.