The "strictest GMP in history" deadline has reached 1800 pharmaceutical companies have been discontinued?


Release time:

2016-02-23


According to media reports, nearly 1800 pharmaceutical companies have been unable to obtain the new GMP certificate, which means that they have stopped production. Whether it is completely accurate or not, this threshold has undoubtedly eliminated many pharmaceutical companies.
The deadline of "the strictest GMP in history" has come.
Drug GMP is the abbreviation of "Good Manufacturing Practice for Drugs", and it is a common way of drug production management in the world. In 2011, China put forward new requirements for pharmaceutical enterprises. Drug production should meet the requirements of the new version of GMP before December 31, 2015. Enterprises and production workshops that fail to pass the new version of GMP certification will stop production, which is called "the strictest GMP in history" by the industry ".
Just a week ago, according to a report from the State Food and Drug Administration, as of January 13 this year, drug manufacturers in 1/4 had not obtained the drug "birth permit" and were facing suspension of production. About 60 in Hubei Province had not passed.
The person in charge of GMP certification of a pharmaceutical company in Enshi, Hubei, told a reporter from the Yangtze River Commercial Daily on February 19 that the time interval between the two GMP revisions was not long, and many pharmaceutical companies had not yet recovered their investment in hardware for the "98 version" GMP certification., We have to face the injection of a new round of funds to transform the hardware again, and many have been delayed. There are also some pharmaceutical companies waiting and expecting the State Food and Drug Administration to "open the net". In the later stage, small and medium-sized pharmaceutical manufacturers simply gave up because they were unable to complete the certification work as scheduled.
In the past few days, a reporter from the Yangtze River Commercial Daily has learned from many industry insiders that all GMP certification authorities will be devolved to provinces this year. GMP certification will gradually merge with production license in the future, that is to say, GMP certification may be canceled in the future.
With the end of the new version of GMP certification, the pharmaceutical production industry will usher in a major reshuffle, through acquisition integration, transfer approval and other ways, a number of small, scattered and chaotic small and medium-sized pharmaceutical enterprises will be eliminated.
Traditional Chinese medicine enterprises become the hardest hit area by "receiving certificates"
Once the "most stringent GMP certification in history" is canceled, does it mean that the "tightening curse" will no longer restrict pharmaceutical companies and the production threshold will be lowered?
A person in charge of the pharmaceutical industry in Hubei, who did not want to be named, lamented that in the past, pharmaceutical companies may have passed GMP certification and everything will be fine, but in the past two years, irregular "flight inspections" have made companies even more worried. If problems are found in one link, the GMP certificate may be withdrawn. He believes that GMP has realized the transformation from certification management to supervision and management. Pharmaceutical companies that have obtained the "birth permit" will face a new round of competition.
Indeed, to get GMP certification is not "once and for all".
A reporter from the Yangtze River Business Daily found on the website of the State Food and Drug Administration that all provinces and cities across the country have announced the revocation of GMP certification in stages. A few days ago, "Statistics on the Recovery of GMP Certificates in 2015" was released. In 2015, 144 GMP certificates from 140 pharmaceutical companies nationwide were recovered. The number for the whole of 2014 was only 50, a nearly two-fold increase.
A reporter from the Changjiang Business Daily learned that on January 6 this year, the Hubei Provincial Food and Drug Administration issued the first "withdrawal announcement" this year: Hubei Huangshi Shixing Pharmaceutical Co., Ltd. seriously violated the "Good Manufacturing Practice (revised in 2010)"., The "Drug GMP Certificate" of oxiracetam raw material was taken back in accordance with the law. This is also the first company in the country to withdraw its GMP certificate this year.
"Now the regulatory authorities of all provinces have increased the density of flight inspections, and more pharmaceutical companies' certificates may be withdrawn in the future." The person in charge of a large pharmaceutical company in Hubei said that companies whose GMP certificates have been withdrawn will face many problems such as suspension of production, inability to participate in drug bidding, and dealer returns. The most optimistic result is to get the certificate back within a year, otherwise it will be considered bankruptcy.
Statistics show that of the 140 companies whose certificates were withdrawn last year, 63 were Chinese medicine and Chinese medicine decoction pieces. According to industry analysts, Chinese medicine companies have become the hardest hit area because they are different from chemical drugs and Chinese patent medicine preparations. Chinese medicine decoction pieces companies generally produce hundreds of varieties, with many batch numbers and small production volume per batch. According to the cost of 4 million yuan per production line, 3 production lines need to invest 12 million yuan.
In fact, the "size" of domestic Chinese herbal medicine companies is generally small. Enterprises with annual sales of more than 100 million yuan only account for about 30%, and small and medium-sized enterprises with less than 50 million yuan account for a considerable proportion. For the latter, the investment of tens of millions is definitely a huge expenditure.
In addition, after the implementation of the new version of the Pharmacopoeia, the requirements for Chinese medicinal materials have increased. In 2015, many decoction pieces companies encountered a wave of returns. The above-mentioned industry insiders predict that decoction pieces companies will undergo a major reshuffle this year.
Drug "birth certificate" difficult to get 1795 pharmaceutical companies to stop production
According to the requirements of the State Food and Drug Administration, starting from March 1, 2011, all new drug manufacturers and new (modified and expanded) workshops of drug manufacturers must pass the new version of GMP certification. The production of sterile drugs such as blood products, vaccines and injections by existing drug manufacturers should meet the requirements of the new GMP before December 31, 2013. The production of other types of drugs should meet the new GMP requirements before December 31, 2015.
Pharmaceutical companies across the country are beginning to worry that only by getting this "birth permit" can they continue to survive, and it is not easy to obtain the new GMP certification.
As of January 13, the State Food and Drug Administration notified that at present, a total of 1/4 of drug manufacturers in my country have not passed GMP certification. According to regulations, since January 1, 2016, companies and production workshops that have not passed the new GMP certification will all Stop production.
According to the data released by the State Food and Drug Administration, there are currently 7179 drug manufacturers in the country, and the 1/4 has not passed, that is, 1795 companies have not passed the certification (according to the 2015 Annual Food and Drug Regulatory Statistics Report published by CFDA, as of the end of November 2015, There are 5065 drug manufacturers nationwide). In fact, when the new version of GMP was introduced in 2011, the industry had already expected that this would cause pharmaceutical companies to reshuffle. The head of the China Pharmaceutical Enterprise Management Association predicts that the buffer period from 2011 to 2013 will end, and the new version of GMP will cause thousands of small and medium-sized pharmaceutical companies to close down. According to historical records, the 1998 version of GMP has led 25% of pharmaceutical companies to withdraw from the market directly.
When the new version of GMP was initially certified, many pharmaceutical companies have been in a mutual wait-and-see state. According to the Shaanxi Food and Drug Administration, as of the end of June 2015, 60% of the enterprises in Shaanxi Province have completed the new version of GMP certification. In other words, although the new version of GMP was introduced in 2011, at least 40% of the enterprises were not certified until half a year before the deadline, which is very common in all provinces of the country.
The person in charge of GMP certification of a pharmaceutical company in Enshi, Hubei, told a reporter from the Yangtze River Commercial Daily on February 19 that the time interval between the two GMP revisions was not long, and many pharmaceutical companies had not yet recovered their investment in hardware for the "98 version" GMP certification., We have to face the injection of a new round of funds to transform the hardware again, and many have been delayed. There are also some pharmaceutical companies waiting and expecting the State Food and Drug Administration to "open the net". In the later stage, small and medium-sized pharmaceutical manufacturers simply gave up because they were unable to complete the certification work as scheduled.
A reporter from the Changjiang Business Daily learned that there are a total of about 305 pharmaceutical manufacturers in Hubei Province, of which about 250 need to pass the new GMP certification. As of December 2015, 66 manufacturers in Hubei have not passed the GMP certification, 11 pharmaceutical manufacturers have given up certification, and 20 pharmaceutical wholesale enterprises and 648 pharmaceutical retail enterprises have closed down.
At present, the Hubei Provincial Food and Drug Administration has sent an inspection team to inspect pharmaceutical companies that have not passed the newly revised drug GMP and GSP (I. e., the "Drug Business Quality Management Practice") certification, focusing on spot checks on whether drug production workshops and retail pharmacies are in accordance with the prescribed time. Stop production and business. In the next step, Hubei Province will formulate detailed rules for the implementation of drug flight inspection (which is carried out without the knowledge of the inspected unit, with careful start and quick action), refine the start-up standards for drug flight inspection, kill "return carbine" by means of follow-up inspection and flight inspection, and comprehensively supervise drug production and trading enterprises.
Increasing the added value of drugs is the fundamental basis for enterprises.
Where will the "eliminated" pharmaceutical companies go? What impact will the new version of GMP have on the industry?
"When this round of new GMP certification is over, those enterprises with" no chance "certificates will be acquired or integrated, and those with no value will only end up going bankrupt. "Zhu Xiaohua, general manager of the Wuhan branch of Beijing Xinchuangjiaye Technology Co., Ltd., said that some companies hold multiple valuable drug approvals. Even if they have not passed the new version of GMP certification, they can accelerate mergers and acquisitions with large and powerful companies that have passed the new version of GMP certification in the future. Integration, to achieve multi-win, in order to master the initiative in the future market competition, this is also the general trend.
A reporter from the Changjiang Business Daily learned that at present, pharmaceutical enterprises in Hubei Province are relatively small, with only about 30% of them with annual sales of more than 100 million yuan, and small and medium-sized pharmaceutical production enterprises with annual sales of less than 0.1 billion yuan and less than 50 million yuan account for a considerable proportion. Take Hubei pharmaceutical enterprises as an example, and then the new version of GMP Dongfeng transformation and upgrading.
In 2011, Wuhan Renfu Pharmaceutical Company became the first batch of pharmaceutical companies in Hubei Province to pass the newly revised GMP certification. The company has built a new 52000 square meter factory building that meets the new GMP certification, and seven new production lines have passed the audit, with a total cost of nearly 0.17 billion yuan. One of the portable suspended particle counter is worth more than 300,000 yuan.
For enterprises with large market demand, new production lines can increase production capacity and dilute production costs. But for small and medium-sized enterprises, the new production line will cause waste due to unsaturated production, but increase the cost. Hubei People's Pharmaceutical Co., Ltd., located in Donghu High-tech Development Zone, is difficult to complete the transformation on its own. In 2011, the company was acquired by Fu 'an Pharmaceutical Group. From bottle washing, ingredients, filling, capping to lamp inspection and outsourcing, the whole process forms a fully automatic computer-controlled production loop with a total cost of 0.15 billion yuan and passed GMP certification in 2013.
In addition, in addition to raising funds or selling production lines, reselling drug approvals is also one of the options for companies with many drug approvals. A person in charge of a pharmaceutical company told a reporter from the Yangtze River Commercial Daily that the company's drug approval documents are equivalent to assets, and some of the drugs are not produced, resulting in idle. If some small enterprises do not intend to do certification, in order to reduce losses, they can transfer some approvals and integrate high-quality resources. Enterprises that acquire approvals can also increase the variety.
In addition, some eliminated pharmaceutical companies may turn their attention to the health care products market. It is reported that China's health products and food production enterprises are required to produce in accordance with GMP certification standards, but do not make mandatory provisions.
"There are too many pharmaceutical factories in China, the industry is scattered, and the good and the bad are mixed. In addition, there is overcapacity and the homogenization of drugs in the market is serious, but the international competitiveness is obviously insufficient." Zhu Xiaohua said that the new version of GMP certification can "force" to standardize products, improve quality, and make the industry naturally eliminated by raising requirements and standards. Set the GMP threshold to eliminate some small and medium-sized enterprises whose products themselves lack competitiveness, and integrate the industry market.
Recently, the General Office of the State Council also officially issued opinions on accelerating the construction of an important product traceability system. The opinion emphasizes that the main content is to promote the whole variety of drugs, the whole process of traceability and supervision, and to build and improve the drug traceability system.
Wang Xuehai, chairman of Renfu Pharmaceutical Group Co., Ltd., said frankly that Chinese pharmaceutical companies generally lack innovation, and the quality of drugs cannot meet the increasing consumer demand of the people. "Chinese people to Japan to buy cold medicine, is a disgrace to Chinese pharmaceutical companies."
"The competitive path of enterprises relying on cost and price has been blocked." He said that 80% of the profits of the domestic pharmaceutical industry are earned by imports and joint ventures. They can no longer rely on low-price and low-cost competition, but rely on high-quality, high-value-added and high-competitiveness, and steadily improve product quality.