The new GMP is a high-threshold enterprise should apply for more preferential policies

The new GMP certification has reached the final stage As of December 31 this year, the production of sterile drugs such as blood products, vaccines and injections should pass the GMP certification of the new version If they fail to pass the certification, production will be stopped The new version of GMP has high requirements, great difficulties and huge transformation costs What is the current situation of certification? Facing the severe situation, where should Chinese pharmaceutical enterprises go? The new GMP is a new version with high threshold, which was issued in 2010 and formally implemented at the beginning of the year The fundamental purpose is to "improve the quality management ability and overall level of enterprises, and improve the level of drug safety assurance in China" Yin Li, deputy director of the State Food and drug administration, said publicly that "the overall pattern of" many, small, scattered and disorderly "in China's drug manufacturing enterprises has not been fundamentally changed The production concentration is low, the ability of independent innovation is insufficient, and the quality management level is uneven The nonstandard production and operation, low-level repetition and excessive competition are the deep-seated causes of a series of drug quality and safety incidents, and also the major issues that drug supervision has to face and solve for a long time The implementation of the new GMP, the promotion of the adjustment of the pharmaceutical economic structure, and the promotion of industrial upgrading are conducive to the establishment of a more complete pharmaceutical production and supply guarantee system, the promotion of the concentration of resources to advantageous enterprises, and the elimination of backward productivity " Therefore, the implementation of GMP is an inevitable need for the development of pharmaceutical enterprises and an inevitable choice for the development of Chinese pharmaceutical industry Statistical data show that the pass rate of new GMP is not high and the progress is not fast There are 1319 sterile drug production enterprises and 4462 production lines in China At present, only 20% of the sterile drug production lines in China have passed GMP certification After 5 months, the maximum limit will come, and the enterprises without certification will stop production GMP threshold sad? The new GMP is like a threshold Some enterprises are put in and some are eliminated Some insiders have analyzed that "the last round of GMP is water releasing, with high standard setting and great industry pressure Finally, we can only pursue the certification result by reducing the standard" Even so, the last round of GMP certification still eliminated thousands of pharmaceutical enterprises At the end of 2004, the statistical data of the drug administration showed that 3731 of the 5071 drug manufacturing enterprises in China had passed GMP certification, and 1340 enterprises that had not passed the certification had stopped production But the GMP companies were also scarred At that time, many small enterprises were in debt of 23 million yuan The new GMP is a great test of capital, talents and management ability Li Zhenjiang, chairman of Shenwei pharmaceutical, told reporters that the threshold of GMP is very high, which increases the concept of quality system and quality risk, pays more attention to science and enterprise quality management system, and is more instructive and operable Since the promulgation of the new GMP certification, it has greatly improved the effective supervision and process control of the drug production process, and improved the requirements of the design, manufacturing, installation and maintenance of the production equipment of pharmaceutical enterprises Its standard requirements have been close to the EU, and domestic enterprises are facing greater pressure of transformation In order to pass the new version of GMP, it is necessary to spend a huge amount of money to transform the plant and equipment "To implement GMP is to seek death, not to implement GMP is to wait for death" quietly spread in pharmaceutical enterprises In addition to the huge funding gap, the improvement of talent and management level is also very important To ensure the normal operation of the equipment, to save energy, to reduce maintenance costs, to extend the service life of the equipment and to reduce drug pollution, to ensure the smooth implementation of the new GMP certification, to improve the economic and social benefits of the enterprise, has become a topic of general concern for pharmaceutical enterprises In response, the head of the State Food and Drug Administration recently told the media: "at present, only a few enterprises have passed the new version of GMP certification, but the new version of GMP standards will not be reduced, and the time will not be relaxed It is useless to find someone to talk with and cry Enterprises that fail to pass the certification at the end of the period must resolutely stop production " For example, Yangzijiang pharmaceutical, one of the largest pharmaceutical enterprises in China, passed the new GMP certification last year For most small and medium-sized pharmaceutical enterprises, the impact is great The pharmaceutical enterprises whose annual sales revenue is less than 50 million yuan account for more than 70% of the total number of enterprises Based on the average investment of 10 million yuan per enterprise in technological transformation, it needs to pay a year's net profit for these small and medium-sized enterprises to complete GMP certification Zhou Yulan, Secretary General of Beijing Pharmaceutical Industry Association, told reporters that the most difficult thing to pass the new GMP is the financial and talent level Most of the pharmaceutical enterprises in Beijing belong to small and medium-sized pharmaceutical enterprises, and their thoughts are not very active Some of their bosses' thoughts stay in the face of "national assistance" They hope that the government will support more funds and give more financial subsidies to pass GMP certification In fact, pharmaceutical enterprises should apply for more preferential policies from the government At present, the policies are more and more open and transparent The government also hopes to let enterprises know more about some preferential policies and hope that enterprises can make good use of them In order to help some small and medium-sized enterprises in Beijing pass the new GMP certification, Beijing Pharmaceutical Industry Association has done a lot of training work Zhou Yulan told reporters: "the government's policy is to promote the development of this industry, and the implementation of the policy requires the joint efforts of enterprises and industry associations." For this reason, the Beijing Pharmaceutical Industry Association has formed an expert team, which is trained by the staff of Beijing Municipal Drug Administration, the experienced person in charge of the member units who have passed the certification, and the relevant experts of the industry association, so as to make the enterprise personnel know how to meet the specifications and make the drug production meet the standards stipulated by the new GMP They work hand in hand with the government, hand in hand with enterprises, build a communication platform for the government and enterprises, and promote the implementation of policies According to the reporter, up to now, 43 pharmaceutical manufacturers in Beijing have passed the new GMP certification in whole or in part, with a total of 55 new certification certificates, including 17 National Bureau certification certificates and 38 Beijing certification certificates Compared with the whole country, the adoption rate is at a high level It is necessary to study policy and find countermeasures Zhang Yan, the head of the Beijing drug regulatory department, told reporters that the government has funds to support the passing of the new GMP On the premise that the inspection standard does not decrease, the Beijing drug regulatory department actively takes measures to help and encourage enterprises to pass the new GMP certification as soon as possible, including the preparation of targeted GMP inspection guide, and organizing enterprises to observe and learn from the new GMP on the spot And so on At the same time, in the bidding process, the dosage forms and varieties passing the new version of GMP will be appropriately scored, and preferential market access policies will be given The reporter learned that in the process of promoting the new GMP certification, Beijing is also paying close attention to two points One is to strengthen the supervision of enterprises that are "shut down and transfer simultaneously", so as to prevent the hidden dangers of drug quality and safety; the other is to focus on the implementation of the new GMP of enterprises with short market or exclusive varieties, and actively take measures when necessary to ensure the supply of products and meet the public demand "Quality is the soul of the development of enterprises, and enterprises should apply their own efforts to improve the quality." "Enterprises that have not passed the new version of GMP can transfer their varieties to large enterprises through technology transfer, cooperate in production, fail to pass the certification, and then continue to transform to pass the certification," Zhang said The door of the new GMP is open to pharmaceutical enterprises " In order to change this situation and improve the quality of Chinese pharmaceutical enterprises, GMP certification system has been implemented in China GMP is the standard of drug production quality management Since the establishment of the State Food and Drug Administration in 1998, GMP has become a necessary production access condition for pharmaceutical enterprises GMP is a global drug production system After nearly 20 years of implementation in China, it plays a great role in improving the quality of drugs.