Drug medical device reform plan

Many types of "old" problems in the pharmaceutical industry will be solved.

On August 18, the Chinese government's website issued the "Opinions of the State Council on Reforming the Examination, Evaluation and Approval System for Pharmaceutical Devices" (hereinafter referred to as "opinions"). The "Opinions" proposes that the examination and approval of the oversupply of drugs in the market should be strictly controlled. We will strive to absorb the accumulated inventory before the end of 2016, realize the balance of annual applications for entry and the number of applications for review as soon as possible, and achieve approval by time limit in 2018.

According to the Opinions, the problems existing in China's review and approval of pharmaceuticals and medical devices have become increasingly prominent. The quality of registered application materials is not high, and the review process needs to be supplemented and improved several times, seriously affecting the efficiency of review and approval batching; duplication of pharmaceuticals and repeated applications. Vicious competition in the market, there is a big gap between the quality of some generic drugs and the international advanced level; clinical approval of new drugs for listing takes too long, and drug R&D institutions and researchers cannot apply for drug registration, which affects the enthusiasm of drug innovation.

At the press conference, Wu Wei, deputy director of the State Food and Drug Administration, frankly stated that the National Drug Evaluation Center is reviewing 21,000 drugs. Of all the backlog drugs, 90% are generic drugs and chemical drugs. More than % are generic drugs. The threshold for generic drugs is low and the volume of applications is large. According to statistics, there are more than 2,000 declarations involving more than 100 varieties.

Increased drug approval standards

According to the research report of Shen Wanhongyuan, in 2014, the average review time for China's 1.1 new drugs, 3.1 new drugs, and 6 new drugs was 42 months, 42 months, and 25 months. The average clinical review time was 14 Months, 28 months and 28 months. Under the same circumstances, from 2003 to 2013, the median time for approval of new drug declaration production in the United States, the European Union, and Japan was 304 days, 459 days, and 487 days, respectively.

A pharmaceutical research and development person in charge in Nanjing told the Morning Post reporter that the approval of a new drug may last for more than eight years, and when it is approved, “new drugs become old drugs”.

Wu Hao also explained that the backlog of drug registration reviews was first caused by history. After 2000, drug review was changed from provinces to national unified reviews, and the number of evaluations increased substantially. However, the corresponding personnel did not keep up, and there were three backlogs. peak. Although some measures were taken at that time, the problem of the backlog of drug review has not been fundamentally solved. The duplication of low-level generic drugs occupies limited review resources.

The way to solve the backlog has been prioritized. In 2014, the Center for Drug Evaluation said that the center conducted research and analysis on the varieties of pharmaceutical patents that were due to expire from 2013 to 2014, totaling 89 varieties, and 62 varieties that have been declared to the drug review center. Research has determined the corresponding evaluation strategy, and these drugs have not yet been listed on the domestic market for similar drugs.

In the “Opinions”, the standards for drug approvals were improved: the new drugs were adjusted from the current “drugs not listed and sold in China” to “pharmaceuticals not listed and sold in China and abroad”, based on the originality and novelty of the material basis. Sex, the new drug is divided into innovative drugs and improved new drugs, the generic drugs from the current "imitate the national standards of the drug" adjusted to "imitation and original research drug quality and efficacy of the same drug."

At the same time, the consistency evaluation of generic drugs will also be promoted. For generic drugs that have already been approved for marketing, quality conformance assessment will be carried out in batches and in phases. Generic drugs that fail to pass quality consistency assessment within the specified time limit will not be re-registered.

In addition, the “Opinions” proposes to speed up the review and approval of drugs for innovative medicines such as AIDS prevention, malignant tumors, major infectious diseases, rare diseases, and children's medicines.

It is worth noting that, in addition to the repeated application of low-level generic drugs, the low number of reviewers and low treatment are also considered to be challenges in the drug review issue.

Wu Hao said that the number of new applications each year currently amounts to 8,000-10,000 pieces, and only 4,000-5,000 pieces can be completed each year. This means that more than 100 review teams will each complete 40-50 pieces per year. This is in contrast to the United States. There is a big gap between the status of developed countries and so on. Now a mature reviewer has an annual income of about 100,000 yuan, while the same level of competence of personnel in research and development institutions, companies pays five times that position, resulting in The loss of people is serious.

Drug licensing

Holder system pilot

The current Chinese pharmaceutical companies have weaker innovation capabilities and policies should try to improve their R&D capabilities.

The "Opinions" said that "to carry out trials for the holders of drug marketing licenses" allows drug R & D institutions and researchers to apply for registration of new drugs. When they are transferred to enterprises for production, they only conduct on-site process inspections and product inspections of production companies, and do not repeat drugs. Technical review.

For this reason, the Opinions also proposes to expedite the revision of laws and regulations, timely summarize the progress of the trials for the holders of medicine marketing licenses, the reform of the registration reform of pharmaceuticals, and accelerate the revision of the “People's Republic of China Drug Administration Law” in conjunction with the reform of the administrative examination and approval system. We must pay close attention to the revision of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" and the "Administrative Measures on Drug Registration" in accordance with the procedures.

Compared with other industries, the pharmaceutical industry is a high-risk industry. On the one hand, the development cycle of new drugs is long and costly. On the other hand, even if new drugs are listed, they may not have sufficient market acceptance rate. In addition, even if the drug R&D problem is solved, it is likely that many companies will be unable to afford the construction of the production base and delay the industrialization, which makes it hard for the domestic R&D team to survive.

The accepted method in the industry is CMO (medical contract outsourcing). However, at present, CMOs have always faced a policy curse at home. Under the current laws and regulations, drug marketing licenses and production licenses adopt a “bundled” management model, and drug approval numbers are issued only to manufacturing companies that have a Pharmaceutical Production License. This means that R & D pharmaceutical companies must build their own factories in order to complete the entire process of industrialization of new drugs, so this policy needs to be loosened.

Many places are also seeking opportunities for pilots. For example, in Zhangjiang Pharmaceutical Valley, in June 2013, it and the German pharmaceutical giant Boehringer Ingelheim jointly established a CMO (Pharmaceutical Contract Outsourcing) biopharmaceutical base. The project was launched in June last year and plans to invest 500 million yuan.

According to the aforementioned person in charge of research and development of pharmaceutical companies, there are many bright spots in the “Opinions”: the establishment of a professional technical review project team, the comprehensive disclosure of pharmaceutical medical device review and approval information, and the severe punishment of counterfeiters, etc. The few companies need to further clarify the issues, such as the specific rules of generic drug conformity assessment.