Editor | Yan Dongxue, Health Knowledge Bureau of AI Finance and Economics Society
This article comes from the Health Knowledge Bureau, a medical and health brand under AI Finance. Reproduction without permission is strictly prohibited.
A new era of drug supervision has arrived.
On April 30th, official website, State Administration of Pharmaceutical Products, posted nine drafts for comments in one breath, covering registration, re-registration, post-marketing clinical changes, vaccine production and circulation at home and abroad, etc.
According to the requirements, people from all walks of life can send feedback to the designated mailbox before May 30, and the final document will directly affect the research and development, registration and re-registration of various drugs two months later.
Since 20 15, with the reform of drug review and approval system and the start of generic drug conformity evaluation, great changes have taken place in China's drug supervision.
In particular, the newly revised Drug Administration Law and Vaccine Administration Law entered the implementation stage from 20 19 to February 1. At the end of March, the measures for the administration of drug registration and the measures for the administration of production were also revised and released on a large scale for the first time after 13 and 18, in which the acquiescence system of clinical trials and the parallel reform of series and parallel will greatly promote the innovation of new drugs in China.
A series of supporting documents released this time will ultimately ensure the above benefits. Combined with the policies of generic drug procurement, consistency evaluation of generic drugs, and dynamic adjustment of medical insurance catalogue, while generic drugs and original drugs that have passed the patent period have entered a period of substantial reshuffle, innovative products with real clinical value will usher in a golden age of research and development and market.
Although there are still some problems in the specific operation of the transition period, it is undeniable that China's drug supervision has begun to shift from focusing on ex ante supervision to patient-centered whole process and whole life cycle supervision. Taking this as an opportunity, China's 2 trillion pharmaceutical market will be reset.
Act in accordance with international practice
The improvement of innovative drug standards emphasizes clinical value.
It can be seen that in the nine exposure drafts, more specific provisions are given on the registration, classification and declaration requirements of chemicals, biological drugs and traditional Chinese medicine.
It is particularly noteworthy that the new definitions of chemical drugs, biological drugs and innovative drugs of traditional Chinese medicine have promoted innovative drugs in China to a new height, and clinical value has become an important measure.
In the field of chemical drugs, new drugs are divided into innovative drugs and improved drugs, which must be unlisted drugs at home and abroad and have clinical value.
For biopharmaceuticals, on the basis of the original preventive and therapeutic uses, in vitro diagnostic reagents managed according to biomass levels have been added. At the same time, it is required to have obvious clinical advantages in improving dosage form, changing administration route and dosage, biological products and so on.
Innovative Chinese medicine also emphasizes clinical value. These include traditional Chinese medicine compound preparations, single animal and plant mineral extracts and their preparations, as well as new medicinal materials and their preparations. According to the requirements, clinical evaluation should be paid more attention to in the research and development of new Chinese medicine to meet the unmet clinical needs.
Products that modify dosage forms, routes of administration and increase indications are also included in the category of improved new drugs. This is considered to promote the further development of old drugs in the Chinese medicine industry.
In fact, the reform of drug registration and classification began as early as 20 16. This is also considered to be the key to the reform of drug evaluation and approval system, which is of great significance to encourage drug research and development innovation and improve quality.
On the basis of previous reforms, the new supporting documents for drug registration are detailed and clear according to the newly revised Measures for the Administration of Drug Registration and the experience of previous reforms, and are closely linked with documents such as technical guidelines for drug research and development. According to the design, they will play a connecting role in the examination and approval system in the future.
In addition, in the process of data declaration, all drug marketing, clinical trials and API applications are required to be declared in CTD format. CTD format is a general technical document for ICH (International Technical Coordination Conference on Drug Registration for Human Use) to apply for drug registration for human use. The measures taken by the State Administration of Pharmaceutical Products have further strengthened the integration of innovative drugs in China with international standards.
This will not only further accelerate the speed of overseas innovative drugs entering China, but also help China innovative drugs to go abroad.
Standardize the management of traditional Chinese medicine
Chinese medicine injections shuffled in the 100 billion market.
In the Special Provisions on the Administration of Registration of Traditional Chinese Medicine (Draft for Comment), there are also normative requirements for the development of traditional Chinese medicine injections, including that the development of traditional Chinese medicine injections must meet the general technical requirements of injection research, the active components and mechanism of action of drugs must be clear, and full non-clinical safety research should be carried out.
This also means that traditional Chinese medicine injections bid farewell to the "preferential treatment" in a special period and will be subject to stricter and more standardized management according to injection standards.
In combination with the requirements in the above-mentioned exposure draft, if any of the taboos, adverse reactions and precautions in the instructions of traditional Chinese medicine are still "unclear" five years after listing, they will no longer be registered, and related products will face the test of post-marketing evaluation.
Traditional Chinese medicine injection, as a unique category in China, has long been criticized for its lack of clinical data. An investigation on the instructions of 30 kinds of traditional Chinese medicine injections led by doctors in Lishui People's Hospital of Zhejiang Province in early years shows that only 4 kinds of products involved have specific clinical trial instructions.
On this basis, the number of adverse drug reactions/reports of traditional Chinese medicine injections is also high, and some major events that caused a sensation in the industry have appeared, such as the death of Houttuynia cordata injection, the emergency suspension of production of Xiyanping and Honghua injection. Among them, the allergic reaction caused by pyrogen is also considered to be the "original sin" that traditional Chinese medicine injections cannot get rid of.
Nevertheless, the sales of traditional Chinese medicine injections are increasing year by year. By the year of 20 16, there are only 100 varieties of traditional Chinese medicine injections, and the market scale has exceeded100 billion yuan.
In recent years, with the implementation of policies such as clinical cost control and strengthening rational drug use, the market of traditional Chinese medicine injections has shrunk due to the restrictions of key monitoring and medical insurance payment.
According to "Article 36 on Encouraging Medical Device Innovation" issued by China Office and State Office 20 17, the re-evaluation of the safety and effectiveness of traditional Chinese medicine injections will also be the most fatal blow to traditional Chinese medicine injections.
Although the post-marketing re-evaluation of injections has not been clearly implemented, based on the new regulatory model, the reshuffle of such products will also enter a substantive stage. The new regulatory model requires post-marketing re-evaluation of all drugs and emphasizes full non-clinical safety research.
It can be seen that the common problems of traditional Chinese medicine injection, such as allergy test, irritation test and hemolysis test, are all important contents of non-clinical safety test.
Improve the exit mechanism
Make it clear that drugs will no longer be registered under five circumstances.
In the draft of the relevant provisions on drug re-registration, five cases of non-registration of drugs produced at home and abroad were put forward.
Specifically including ↓
In other words, a large number of drugs will be eliminated with the opportunity of re-registration.
Especially for generic drugs that must pass the consistency evaluation, according to the relevant requirements, after the first variety passes the consistency evaluation, the same variety of other pharmaceutical manufacturers should complete the consistency evaluation within 3 years in principle. Varieties that are overdue, not clinically necessary and in short supply will face the fate of no longer registering and eventually delisting.
Figure/vision china
Since 1980s, the pharmaceutical market in China has developed rapidly. According to the statistics of the Ministry of Commerce, the total scale of the national pharmaceutical market in 20 17 has exceeded 2 trillion yuan. According to the official data of the State Administration of Pharmaceutical Products, the approval number of domestic drugs has reached more than 654.38+0.6 million.
But behind the prosperity, because there is no exit mechanism, in fact, many drugs that have not been produced for a long time have not been cancelled, and many drugs that have been banned or restricted by children abroad are still unimpeded in the China market. This is not conducive to industrial development, but also increases the risk of medication.
More importantly, according to the requirements of the newly revised Drug Administration Law, drugs with uncertain efficacy, large adverse reactions or other reasons that endanger human health will be cancelled.
In addition, the Regulations on the Administration of Vaccine Production and Circulation (Draft for Comment) also puts forward strict requirements on vaccine access, production license application, commissioned production and production process control. The frequency and intensity of inspections and inspections by drug supervision departments will also increase.
The State Administration of Pharmaceutical Products will conduct annual vaccine inspection for vaccine marketing license holders; The provincial drug supervision department will carry out two inspections on the entrusted production enterprises, including GMP compliance inspection and inspection of distribution institutions and disease prevention and control institutions at the same level; Cities and counties will also inspect disease control institutions and inoculation units at the same level.
Once a problem is found, according to the requirements of the Vaccine Management Law, a heavy penalty of 30 to 50 times the maximum production, sales and sales amount will be imposed.
Undoubtedly, with the continuous release and implementation of Drug Administration Law, Vaccine Administration Law and related supporting documents, the reform of China's pharmaceutical market will be more and more profound.
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