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Three years of pharmaceutical reform, five major changes, affecting all pharmaceutical companies
Source:赛柏蓝
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Author:赛柏蓝
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Published time: 2018-08-20
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This article is to commemorate the 3rd anniversary of the publication of article 44.
For a long time, China's new drug research and development ability is low and accessibility is poor (Figure 1). Generic drugs cannot replace the original research due to their low level. The film "I Am not The God of Medicine" highlights this contradiction.
For this reason, in the past three years, China's pharmaceutical industry has launched an unprecedented reform, attracting the attention of peers around the world. This reform, which started with Document No. 44 and culminated in two documents in 2017, has exerted a profound influence on the pharmaceutical industry, aiming at reaching international standards. According to the statistics of McKinsey expert Wang Jin, since the State Council issued the Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices (Hereinafter referred to as "Document 44"), a total of 250 documents, regulations and opinions related to the reform have been issued between 2015 and May 2018, with a new policy issued every four days on average.
On the occasion of the 3rd anniversary of document No. 44 (2015.08.18), we hereby review the achievements of pharmaceutical reform in the past 3 years from the aspects of innovation, imitation, data verification, flight inspection, international standards and so on.
New drugs should be "new"
No. 44 of the State Council defines new drugs from the current "did not go on sale in the territory of China medicine" changed to "not publicly listed company in China selling drugs", return to the real connotation of "new drug", of course for new drug research and development are also put forward higher requirements, but no. 44 a landmark document encourage pharmaceutical innovation, created a good policy environment for Chinese pharmaceutical innovation, from then on, China pharmaceutical innovation into the fast lane, has made some progress.
1. The number of independent new drug declarations in China has increased significantly
For a long time, China's new drug research and development ability is low and accessibility is poor (Figure 1). Generic drugs cannot replace the original research due to their low level. The film "I Am not The God of Medicine" highlights this contradiction.
For this reason, in the past three years, China's pharmaceutical industry has launched an unprecedented reform, attracting the attention of peers around the world. This reform, which started with Document No. 44 and culminated in two documents in 2017, has exerted a profound influence on the pharmaceutical industry, aiming at reaching international standards. According to the statistics of McKinsey expert Wang Jin, since the State Council issued the Opinions on Reforming the Evaluation and Approval System of Drugs and Medical Devices (Hereinafter referred to as "Document 44"), a total of 250 documents, regulations and opinions related to the reform have been issued between 2015 and May 2018, with a new policy issued every four days on average.
On the occasion of the 3rd anniversary of document No. 44 (2015.08.18), we hereby review the achievements of pharmaceutical reform in the past 3 years from the aspects of innovation, imitation, data verification, flight inspection, international standards and so on.
New drugs should be "new"
No. 44 of the State Council defines new drugs from the current "did not go on sale in the territory of China medicine" changed to "not publicly listed company in China selling drugs", return to the real connotation of "new drug", of course for new drug research and development are also put forward higher requirements, but no. 44 a landmark document encourage pharmaceutical innovation, created a good policy environment for Chinese pharmaceutical innovation, from then on, China pharmaceutical innovation into the fast lane, has made some progress.
1. The number of independent new drug declarations in China has increased significantly
2. The number of biological analogues in research in China has ranked first in the world
3. China's new drug r&d results have been recognized by international peers
4. New drug development in China is recognized by the securities market
5.China engaged in new drug research and development companies in the global ratio from 4% in 2016 to 5% in 2017 in April, the formal implementation of the new Hong Kong stock exchange listing rules, allowing no revenues and profits are still in the stage of r&d biotech login of the securities market, this is a high recognition of Chinese medicine research and development achievements, at present, the existing pharmaceutical research and development enterprises ge li, paekche shenzhou successful listing, such as type and HuaLing medicine, cinda several research and development company is an IPO.
6.China's investment in pharmaceutical r&d is growing at the fastest rate in the world
Imitation should be "the same"
China is generics superpower, but the quality of generic drugs and curative effect with the original research there is large gap, the foreign original medicine patent period in China is still at a high price and continue to monopoly market, caused a huge burden to patients, March 5, 2016, The General Office of the State Council about the opinions of the consistency to carry out the quality of generic drugs and curative effect evaluation, requirements of generic drugs to consistent with the quality of the original drug effect, and provisions of the national basic medicine catalogue (2012 edition) approved before October 1, 2007 of 289 chemicals generics oral solid preparation, should be finished by the end of 2018 consistency evaluation, If the same variety of other drug manufacturers has not been completed within three years after the self-confessed varieties have passed the consistency evaluation, they shall not be re-registered. If there are more than 3 manufacturers of the same variety of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procurement. If there are not more than 3, the varieties that have passed the consistency evaluation will be given priority to purchase and use.
By the end of 2017, 19 supporting documents had been issued. By August 17, 2018, the acceptance number of consistency evaluation undertaken by CDE had reached 311, with a total of 139 varieties. Among them, there are 136 varieties in 289 catalog, totaling 52 varieties. There are 60 injectable acceptance Numbers and a total of 30 varieties. A few days ago, I have published the following article specifically, here no longer elaborate.
The data should be "true"
Due to historical reasons, clinical trial data authenticity exist serious problem, it is the leading cause of the past research and development of Chinese medicine quality is not high, the main reasons for the July 22, 2015, the original CFDA issued "about a drug clinical trial data comprehensive inspections of announcement (commonly known as" industry "the 722 massacre") for 1622 clinical trials after checking and verification of 203 varieties, 463 registered clinical trial institution to carry out the on-site inspection, on suspicion of fraud data of 27 varieties, 11 clinical trial institution and contract research organization (CRO) to initiate an investigation, Enterprises voluntarily withdrew and verified 1,323 registration applications that were not approved. A series of measures have completely changed the poor situation of clinical trials in China.
China is generics superpower, but the quality of generic drugs and curative effect with the original research there is large gap, the foreign original medicine patent period in China is still at a high price and continue to monopoly market, caused a huge burden to patients, March 5, 2016, The General Office of the State Council about the opinions of the consistency to carry out the quality of generic drugs and curative effect evaluation, requirements of generic drugs to consistent with the quality of the original drug effect, and provisions of the national basic medicine catalogue (2012 edition) approved before October 1, 2007 of 289 chemicals generics oral solid preparation, should be finished by the end of 2018 consistency evaluation, If the same variety of other drug manufacturers has not been completed within three years after the self-confessed varieties have passed the consistency evaluation, they shall not be re-registered. If there are more than 3 manufacturers of the same variety of drugs that have passed the consistency evaluation, the varieties that have not passed the consistency evaluation will no longer be selected for centralized drug procurement. If there are not more than 3, the varieties that have passed the consistency evaluation will be given priority to purchase and use.
By the end of 2017, 19 supporting documents had been issued. By August 17, 2018, the acceptance number of consistency evaluation undertaken by CDE had reached 311, with a total of 139 varieties. Among them, there are 136 varieties in 289 catalog, totaling 52 varieties. There are 60 injectable acceptance Numbers and a total of 30 varieties. A few days ago, I have published the following article specifically, here no longer elaborate.
The data should be "true"
Due to historical reasons, clinical trial data authenticity exist serious problem, it is the leading cause of the past research and development of Chinese medicine quality is not high, the main reasons for the July 22, 2015, the original CFDA issued "about a drug clinical trial data comprehensive inspections of announcement (commonly known as" industry "the 722 massacre") for 1622 clinical trials after checking and verification of 203 varieties, 463 registered clinical trial institution to carry out the on-site inspection, on suspicion of fraud data of 27 varieties, 11 clinical trial institution and contract research organization (CRO) to initiate an investigation, Enterprises voluntarily withdrew and verified 1,323 registration applications that were not approved. A series of measures have completely changed the poor situation of clinical trials in China.
Supervision should be strict
Drug production is an important link of the drug quality and curative effect, though China has updated the two version of the GMP, hardware is tall, but a software problem, the way of checking it become a mere formality, companies made a deal with in advance, so as to conceal the existence of the problem, on September 1, 2015, the pharmaceutical medical instrument flight check method ") formally implemented, inspectors, launched a sudden fly years ills have been exposed and corrected.
Drug production is an important link of the drug quality and curative effect, though China has updated the two version of the GMP, hardware is tall, but a software problem, the way of checking it become a mere formality, companies made a deal with in advance, so as to conceal the existence of the problem, on September 1, 2015, the pharmaceutical medical instrument flight check method ") formally implemented, inspectors, launched a sudden fly years ills have been exposed and corrected.
Connect with the international community
1. Eliminate the backlog of registration applications
In the past, drug review and evaluation took too long in China (Figure 8), which seriously affected the accessibility of drugs and caused a large backlog of drug registration applications.
On February 26, 2016, issued a "about addressing drug registration for priority review backlog of examination and approval opinions", solved the lasted 20 years review backlog play, waiting for the review of drug registration number from 2015 in 22000, to the end of 4000, 2017 average drug review time from 4.49 years in 2015, 2018 53 days.
1. Eliminate the backlog of registration applications
In the past, drug review and evaluation took too long in China (Figure 8), which seriously affected the accessibility of drugs and caused a large backlog of drug registration applications.
On February 26, 2016, issued a "about addressing drug registration for priority review backlog of examination and approval opinions", solved the lasted 20 years review backlog play, waiting for the review of drug registration number from 2015 in 22000, to the end of 4000, 2017 average drug review time from 4.49 years in 2015, 2018 53 days.
2.Priority review
On December 28, 2017, the original CFDA issued and implemented the Opinions on Encouraging Drug Innovation to Have Priority Review and Approval (No. 126 [2017] of Food and Drug Administration), which specified that seven cases, including "Application for registration of innovative Drugs not marketed in and outside China", could be included in the priority review scope. Through the priority review system, a number of "global new" drugs were approved for clinical use, and a number of innovative drugs and drugs in urgent clinical need were approved for marketing. As of August 17, the national Bureau published 31 batches to be included in the list, among them, 632 acceptance number, 281 varieties were formally included in the priority review, more than 100 varieties were approved to be on the market.
On December 28, 2017, the original CFDA issued and implemented the Opinions on Encouraging Drug Innovation to Have Priority Review and Approval (No. 126 [2017] of Food and Drug Administration), which specified that seven cases, including "Application for registration of innovative Drugs not marketed in and outside China", could be included in the priority review scope. Through the priority review system, a number of "global new" drugs were approved for clinical use, and a number of innovative drugs and drugs in urgent clinical need were approved for marketing. As of August 17, the national Bureau published 31 batches to be included in the list, among them, 632 acceptance number, 281 varieties were formally included in the priority review, more than 100 varieties were approved to be on the market.
3.A batch of "new global" drugs has been approved for clinical use
4.Accelerate the import
On October 10, 2017, the former CFDA issued the Decision on Adjusting The Registration Administration of Imported Drugs, encouraging the simultaneous clinical trials of new drugs that are not listed abroad to be carried out both at home and abroad after being approved, so as to shorten the time interval between domestic and foreign markets and meet the public's clinical demand for new drugs. Before 2015, domestic patients were on average seven years late to receive imported new drugs. Now, the latest pD-1 target anti-tumor drug Keytruda was launched in China 4 years later than FDA, OPDIVO was launched in China 3 years later than FDA, and EPCLUSA and oxitinib were only 2 years later than FDA. The 9-valent HPV vaccine has been on the market for only 8 days.
On October 10, 2017, the former CFDA issued the Decision on Adjusting The Registration Administration of Imported Drugs, encouraging the simultaneous clinical trials of new drugs that are not listed abroad to be carried out both at home and abroad after being approved, so as to shorten the time interval between domestic and foreign markets and meet the public's clinical demand for new drugs. Before 2015, domestic patients were on average seven years late to receive imported new drugs. Now, the latest pD-1 target anti-tumor drug Keytruda was launched in China 4 years later than FDA, OPDIVO was launched in China 3 years later than FDA, and EPCLUSA and oxitinib were only 2 years later than FDA. The 9-valent HPV vaccine has been on the market for only 8 days.
5.MAH
In the past, only drug manufacturers were allowed to hold drug approvals in China, which discouraged researchers and contributed to the high number of drug manufacturers.
On June 6, 2016, the "Drug Marketing License Holder System Pilot Program" (MAH) was issued, allowing all enterprises with approval certificate number to be listed license holders, which is conducive to drug r&d institutions and researchers to actively create new drugs; It is conducive to the adjustment of industrial structure and the optimal allocation of resources, the promotion of professional division of labor, the improvement of industrial concentration, and the avoidance of repeated investment and construction. As of December 23, 2017, the original CFDA has received a total of 560 registration applications.
In the past, only drug manufacturers were allowed to hold drug approvals in China, which discouraged researchers and contributed to the high number of drug manufacturers.
On June 6, 2016, the "Drug Marketing License Holder System Pilot Program" (MAH) was issued, allowing all enterprises with approval certificate number to be listed license holders, which is conducive to drug r&d institutions and researchers to actively create new drugs; It is conducive to the adjustment of industrial structure and the optimal allocation of resources, the promotion of professional division of labor, the improvement of industrial concentration, and the avoidance of repeated investment and construction. As of December 23, 2017, the original CFDA has received a total of 560 registration applications.
This article was originally created by Dr. Zhang Ziran. Please indicate the author of the chart, and the offender shall be corrected!
In addition, in June 2017 CFDA joined with drug registration technical requirements (ICH) international coordination meeting, marked the drug regulatory system of China's real woven into the regulation of the international recognition system, a large number of scientists returned to the motherland is engaged in medical research, a large number of marketization of capital into the medical field, a lot of multinational pharmaceutical enterprises to strengthen the recognition and input to the Chinese pharmaceutical market, has been through the variety of the consistency evaluation in bidding to replace the original lower health care spending, national health insurance bureau will be more generic substitution as a key to save medicare money, strengthen the matter later regulation, The concept of full life cycle management of drugs has been continuously implemented, which indicates that the reform of the pharmaceutical industry in the past three years has been well recognized by all parties.
Change medicine has paid off, so should be timely summary, will experience up to the system and regulations, and unswervingly continue, believe in the near future, would considerably increase our capacity for independent innovation of China's pharmaceutical, generic level increases significantly, improve the accessibility of drugs and reduce the drug expenditure to become a reality, actually benefit patients.
In addition, in June 2017 CFDA joined with drug registration technical requirements (ICH) international coordination meeting, marked the drug regulatory system of China's real woven into the regulation of the international recognition system, a large number of scientists returned to the motherland is engaged in medical research, a large number of marketization of capital into the medical field, a lot of multinational pharmaceutical enterprises to strengthen the recognition and input to the Chinese pharmaceutical market, has been through the variety of the consistency evaluation in bidding to replace the original lower health care spending, national health insurance bureau will be more generic substitution as a key to save medicare money, strengthen the matter later regulation, The concept of full life cycle management of drugs has been continuously implemented, which indicates that the reform of the pharmaceutical industry in the past three years has been well recognized by all parties.
Change medicine has paid off, so should be timely summary, will experience up to the system and regulations, and unswervingly continue, believe in the near future, would considerably increase our capacity for independent innovation of China's pharmaceutical, generic level increases significantly, improve the accessibility of drugs and reduce the drug expenditure to become a reality, actually benefit patients.
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