Major revision! List of essential medicines, new policy of traditional Chinese medicine, online sales of prescription drugs, MAH... Various regulations are being solicited for comments

The draft revision of the Implementation Regulations of the Drug Administration Law for comments has a total of 181 articles in ten chapters and nearly 30,000 words. The legal provisions were refined, the supervision and management measures were improved, the connection between executions was added, supervision support was strengthened, and further regulations were made on the production, operation and supply guarantee of drugs. In particular, there are clear regulations on the production management of Chinese herbal decoction pieces and formula granules, and the management of drug online sales.

On May 9, 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)" to solicit public comments. The deadline for feedback is June 9, 2022, and there is only one month left!

The draft for comments has ten chapters and 181 articles. Compared with the current Implementation Regulations of the Drug Administration Law of the People's Republic of China, there are 101 more articles in the full text. Not only the special chapters for drug marketing authorization holders and drug supply guarantees are added, but the remaining chapters It is also revised and enriched on the basis of the relevant content of the current "Regulations".

The current "Regulations" were published in 2002. After 20 years, the "Regulations for the Implementation of the Drug Administration Law" were finally printed and revised. Previously (2017), a revised version of the "Regulations for the Implementation of the Drug Administration Law" was released.

This time, the draft for comments adjusted the incompatible content of the current Regulations and refined the specific management in accordance with the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, which came into effect on December 1, 2019. The regulations include general provisions, drug development and registration, drug marketing license holders, drug production, drug distribution, pharmaceutical management of medical institutions, drug supply guarantee, supervision and management, legal responsibilities and supplementary provisions, with a full text of nearly 30,000 words.

Let's take a look at the relevant highlights:

Drug Marketing Authorization System

Qualification requirements for holders: The holder of a drug marketing license shall obtain a drug production license in accordance with the provisions of the drug regulatory department of the State Council, set up an independent quality management department and a pharmacovigilance department, and assign a special quality person in charge in accordance with the requirements of relevant quality management standards. , quality authorized person, person in charge of pharmacovigilance, to perform the duties of quality management, market release, pharmacovigilance, etc.

The person in charge of quality, the person authorized for quality, and the person in charge of pharmacovigilance of the drug marketing license holder shall file with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located. The specific management regulations shall be formulated by the drug regulatory department of the State Council.

Essential drug management

The competent health department of the State Council, together with the medical security and drug supervision and administration departments of the State Council, shall formulate a national essential drug list according to the needs of basic drugs for disease diagnosis and treatment, and conduct regular evaluation and dynamic adjustment. The adjustment period shall not exceed 3 years in principle.

Drugs that are newly approved for marketing, have significantly improved efficacy compared with existing drugs and are reasonably priced can be included in due course. Encourage medical institutions to prioritize the procurement and use of essential medicines.

Medication for children

The state encourages the development and innovation of children's medicines, supports drug marketing license holders to develop new varieties, new dosage forms, and new specifications of children's medicines that meet the physiological characteristics of children, and gives priority review and approval to children's medicines. During the period of drug development and registration application, strengthen communication with sponsors, promote the accelerated marketing of children's drugs, and meet the clinical drug needs of children.

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 marketing.

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

Drugs for rare diseases

The state encourages the development and innovation of drugs for rare diseases, supports drug marketing license holders to develop drugs for rare diseases, encourages the development of new indications for rare diseases of drugs already on the market, and gives priority review and approval to drugs for rare diseases that are urgently needed in clinical practice. During the period of drug development and registration application, strengthen communication with sponsors, promote the accelerated listing of drugs for rare diseases, and meet the clinical drug needs of patients with rare diseases.

For new rare disease drugs approved for marketing, under the condition that the drug marketing license holder promises to guarantee the supply of drugs, a market exclusivity period of up to 7 years will be given, during which the same varieties will not be approved for marketing. If the drug marketing authorization holder fails to fulfill the supply guarantee commitment, the market exclusivity period shall be terminated.

Switching between prescription and over-the-counter drugs

For a prescription drug that has been approved for marketing, if the drug marketing license holder believes that it meets the conditions and requirements for non-prescription drugs through post-marketing research, it may apply to the drug regulatory department of the State Council.

For over-the-counter drugs that have been approved for marketing, if they are found to have potential risks after adverse reaction monitoring and post-marketing research, and they are not suitable to be managed as over-the-counter drugs, the marketing and sales should be stopped.

The holder of the drug marketing authorization shall conduct sufficient research and submit an application for prescription drugs to the drug regulatory department of the State Council. Those who meet the requirements after review may be converted into prescription drugs; if the risks outweigh the benefits after evaluation, the drug approval certificate shall be cancelled. And recall the sold drugs.

Management of Chinese Herbal Pieces and Formula Granules

The origin and processing of traditional Chinese medicinal materials shall not adversely affect the quality of traditional Chinese medicinal materials.

[Administration of Approval and Administration of Decoction Pieces of Traditional Chinese Medicine] The drug regulatory department of the State Council, together with the competent department of traditional Chinese medicine, includes the decoction pieces of traditional Chinese medicine that are traditionally managed according to preparations, some decoction pieces of traditional Chinese medicine processed by complex techniques, and other decoction pieces of traditional Chinese medicine that require approval and management. List of varieties of Chinese herbal medicines. The drug regulatory department of the State Council shall examine and approve the decoction pieces of traditional Chinese medicines listed in the catalogue, and approve their quality standards and processing procedures.

The state implements variety filing management for formula granules of traditional Chinese medicine, and the manufacturer shall file with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located before listing.

[Production management of Chinese herbal decoction pieces] The production enterprise of Chinese herbal decoction pieces shall establish a quality management, risk prevention and control and traceability system for Chinese herbal decoction pieces, and implement whole-process management of the processing and sales of Chinese herbal decoction pieces.

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 packaging.

[Management of TCM Formula Granules] An enterprise producing TCM formula granules shall have the complete production capacity of processing, extracting, concentrating, drying, and granulating TCM decoction pieces, and process TCM decoction pieces for the production of TCM formula granules by themselves.

Manufacturers of traditional Chinese medicine formula granules shall fulfill the main responsibility and related obligations of the whole life cycle of medicines, implement whole-process management of production, follow the relevant requirements of the Good Manufacturing Practice for Medicines, establish a traceability system, and have risk management capabilities.