101 new items added!

Recently, the State Food and Drug Administration issued the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China (Draft for Comments)" (hereinafter referred to as the "Draft for Comments") for public commen.

This draft has 181 articles in ten chapte.

Let’s go with the author to sort out and see what content has been added to the draft? Which ones are the most important things to focus on!

1

First Approved Pediatric Drug

 Market exclusivity period of up to 12 months

Article 28 [Children's Drugs] The state encourages the development and innovation of children's drugs, supports drug marketing authorization holders to develop new varieties, new dosage forms, and new specifications of children's drugs that meet the physiological characteristics of children, and gives priority to children's drugs Review and approv.

For the first new varieties, dosage forms and specifications for children approved for marketing, and for children with increased indications or usage and dosage, a market exclusivity period of up to 12 months will be given, during which the same varieties will not be approved for marketi.

Applicants are encouraged to submit research and development plans for children's dosage forms, strengths, and dosage when submitting a drug marketing authorization applicati.

[Interpretation] In recent years, how to encourage the development of children's medicines has always been the focus of policy inclinati.

 2

Encourage rare disease drug research and development

Market exclusivity period of up to 7 years

Article 29 Rare Disease Rare disease drugs are given priority review and approv.

For new rare disease drugs approved for marketing, under the condition that the drug marketing license holder promises to ensure the supply of the drug, a market exclusivity period of up to 7 years will be given, during which the same variety will not be approved for marketi.

[Interpretation] The market exclusivity period is a common method in Europe and the United States to encourage the development of rare disease dru.

 3

Encourage the inheritance and innovation of traditional Chinese medicine

Article 30 [Definition and Management System of Traditional Chinese Medicine] The term “traditional Chinese medicine” as used in the Drug Administration Law refers to medicinal substances and their preparations used under the guidance of the theory of traditional Chinese medicine, including Chinese medicinal materials, Chinese medicinal decoction pieces, Chinese medicinal granules and proprietary Chinese medicin.

The drug regulatory department of the State Council has established a full-life-cycle management system that conforms to the characteristics of traditional Chinese medicine to promote the high-quality development of traditional Chinese medici.

Article 31 [General requirements for the evaluation of traditional Chinese medicines] The drug regulatory department of the State Council shall meet the major strategic needs of the country and the needs of people's life and health, follow the laws of traditional Chinese medicine research and development, scientifically and rationally set the technical requirements for traditional Chinese medicine evaluation, establish traditional Chinese medicine theory, traditional Chinese medicine human use A review evidence system combining experience and clinical tria.

Article 32 [Protection and Utilization of Medicinal Material Resources] Traditional Chinese medicine resources are derived from animals, plants and minerals, and in principle do not include substances derived from genetically modified animals and plants and substances modified by chemica.

The state encourages the use of authentic medicinal materials and strictly restricts the use of wild animals as medicin.

Article 33 [Traditional Chinese medicinal materials subject to approval management] The state encourages the cultivation of Chinese medicinal materials and increases new medicinal resourc.

Newly discovered substances with medicinal value and derived from animals, plants or minerals, as well as substances derived from medicinal plants introduced from abroad, shall be approved by the drug regulatory department of the State Council and be included in the use of Chinese medicinal materia.

[Interpretation] This draft for comments highly affirms drug innovation, especially the inheritance and innovation of traditional Chinese medici.

In recent years, the state has vigorously encouraged the innovation of traditional Chinese medicine, and has issued a number of policies to support the research and development of traditional Chinese medici.

In September 2020, the State Food and Drug Administration officially issued the "Implementation Opinions on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicin.

According to the characteristics, innovation degree and research and development of registered traditional Chinese medicine products, the classification of traditional Chinese medicine registration is reformed, and registration is no longer only based on material bas.

Based on the classification, open up a registration application path with traditional Chinese medicine characteristi.

Under this policy, the Chinese medicine review and approval system has ushered in improveme.

Priority review and approval shall be implemented for applications of new traditional Chinese medicines with clear clinical positioning and obvious clinical value, which are used for the prevention and treatment of major diseases, rare diseases, urgent clinical needs but are in short supply in the market, or belong to children's medicin.

Article 66 [Production Management of Decoction Pieces of Traditional Chinese Medicine] Manufacturers of decoction pieces of traditional Chinese medicine shall establish a quality management, risk prevention and control and traceability system for decoction pieces of traditional Chinese medicine, and implement whole-process management of the preparation and sale of decoction pieces of traditional Chinese medici.

Manufacturers of Chinese herbal decoction pieces shall not entrust the production, nor shall they purchase Chinese herbal decoction pieces in separate packages or sell them after changing the packagi.

[Interpretation] This is the first time that this is stipulated from the regulatory level, which means that the exploration of the commissioned production of Chinese herbal decoction pieces will end, and it will also end the previous unclear provisions of the Drug Administration L.

 4

The first to successfully challenge the patent and be the first to be approved for listing

Chemical generic drugs are given a market exclusivity period

Article 39 [Promoting the Development of Generic Drugs] The state encourages the development of generic drugs, and grants a market exclusivity period to the first chemical generic drug that successfully challenges a patent and is approved for marketi.

The drug regulatory department of the State Council shall no longer approve the marketing of the same variety of generic drugs within 12 months from the date of approval of the drug, except for the successful joint challenge of the pate.

The term of market exclusivity shall not exceed the term of the original patent right of the challenged dr.

[Interpretation] The opinion draft also brings "bonus" to the development of generic dru.

A market exclusivity period will be given to the first chemical generic drug that successfully challenges the patent and is approved for marketi.

And within 12 months from the date of approval of the drug, the same variety of generic drugs will no longer be approved for marketing, except for the successful joint challenge of the pate.

5

Refinement of domestic and overseas MAH situations

Article 22 [Applicant Requirements] If the drug marketing authorization applicant is different from the drug clinical trial sponsor, the drug marketing authorization applicant shall bear the relevant obligations and responsibilities of the marketing authorization applicati.

During the drug registration application stage, the applicant and the drug trial production site should be both within the territory of China or both within the territory of the count.

Article 69 [Sectional production management] For innovative drugs with special requirements for production technology, facilities and equipment, or drugs that are urgently needed in clinical practice, they may be produced in stages with the approval of the drug regulatory department under the State Counc.

Where the drug production process involves multiple production locations, the marketing authorization holder shall establish a unified quality assurance system covering the entire drug production process and all production sites to ensure that the drug production process continues to meet statutory requiremen.

[Interpretation] Whether it is the introduction of new drugs from abroad or the export of new domestic drugs to the sea, there may be situations in which the marketing authorization holder and the entrusted manufacturer are not located in China or abro.

At present, our country has not released staged production, let alone staged production commissioned by M.

For example, staged production of biological product stock solutions and preparations is not allow.

This draft has optimized and adopted opinions on the problems currently encountered, such as staged production and multi-location producti.

For innovative drugs that have special requirements for production technology, facilities and equipment, or drugs that are urgently needed in clinical practice, they may be produced in stages with the approval of the drug regulatory department under the State Counc.

Where the production process of a drug involves multiple production locations, the holder of the drug marketing authorization shall establish a unified quality assurance system covering the entire process of drug production and all production locations to ensure that the drug production process continues to comply with statutory requiremen.

 6

Scientific and open attitude to accept overseas data

Reduce repetitive development and improve R&D efficiency

Article 23 [Overseas Data Acceptance] If the clinical trial data obtained by the applicant overseas meets the requirements of the drug regulatory department of the State Council, it can be used for the application for drug marketing authorizati.

For international multi-center drug clinical trials conducted by overseas enterprises in China, if the relevant requirements are met, the clinical trial data can be used for drug marketing authorization applicatio.

[Interpretation] As long as the clinical data at home and abroad are true and scientifically acceptable, this is a great progress, saves resources, and can speed up drug approval and marketi.

7

GMP inspection

Article 60 [Marketing of large-scale drugs before registration] For commercial-scale batches of drugs whose quality standards and production processes are consistent with the registration certificate, the production process conforms to the drug production quality management standard, and after obtaining the drug registration certificate, it meets the requirements for product relea.

If required, it can be marketed and sold; the holder of the drug marketing license shall strengthen its production and sales management and risk manageme.

[Interpretation] This clause should be the biggest highlight of the implementing regulatio.

One is that the dynamic batch can be listed for sale from the previous verification, which is expanded to the pre-market verification bat.

When the enterprise obtains the approval document and passes the license and GMP compliance inspection, the verification batch can also be evaluated and listed; After approval, commercial batch products can be produced and put into production in advan.

After obtaining approval and GMP approval, these pre-produced products can also be marketed, which greatly shortens the time for new products to be market.

8

Compassionate Medication Legislation

Improve access to medicines in special situations

Article 100 [Compassionate use of drugs] For drugs that are undergoing clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment, the physician believes that the benefits may outweigh the risks based on the medical analysis of the patient's condition, and the patient cannot participate in the drug For clinical trials, patients can be advised to use the experimental drug compassionate.

Compassionate use of experimental drugs should follow the principles of patients' voluntary requirements, medical ethics and informed conse.

After the review and consent of the ethics committee, physicians with experience in using or training the experimental drugs can be used to communicate with the subjects in the institution conducting the clinical tri.

patients with the same conditi.

[Interpretation] Compared with the new "Drug Administration Law" on "sympathetic drug use", the opinion draft adds the principle of "patient voluntary reques.

Therefore, the principle requires "the physician believes that the benefits may outweigh the risks based on the medical analysis of the patient's condition and the patient cannot participate in the clinical trial of the drug" and "make a recommendation (the patient decides on his ow.

" At the same time, the requirements for physicians have also been further improved, requiring physicians to have experience in the use or training of experimental drugs, and further reduce unnecessary risks in compassionate medicati.

summary

In general, the "Draft Amendment of the Drug Administration Law" further formulates more detailed regulations and puts forward specific requirements for drug research and development, production, operation, use and supervision, e.

, for the innovation of medicine, whether it is the first generic innovative product or the innovation of rare diseas.

The market exclusivity period for medicines has greatly encouraged pharmaceutical innovation and strengthened intellectual property protecti.