Soliciting opinions on the implementation regulations of the Drug Administration Law: new drugs such as rare diseases can enjoy the market monopoly period
2022-05-11
According to the official website of the State Food and drug administration, in order to further strengthen drug supervision and administration, the State Food and Drug Administration recently 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) to solicit opinions from the public. The deadline for feedback is June 9, 2022. Among them, the "exposure draft" proposed that the State encourages the development and innovation of drugs for children and drugs for rare diseases, and encourages the development of generic drugs. For the first approved new varieties, dosage forms and specifications for children, the first approved new drugs for rare diseases, the first successful patent challenge and the first approved chemical generic drugs, a certain market monopoly period shall be given. Encourage innovation Speed up the listing channel It is reported that the draft for comments includes 181 articles in 10 chapters, including general provisions, drug development and registration, drug marketing license holders, drug production, drug trading, pharmaceutical management of medical institutions, drug supply guarantee, supervision and management, legal liability and supplementary provisions, an increase of 101 articles compared with 80 articles in 10 chapters of the current regulations for the implementation of the drug administration law of the people's Republic of China. In terms of drug development and registration, the exposure draft proposes to encourage innovation. The state will improve the drug innovation system, support basic research, applied research and original innovation of drugs, support clinical value oriented drug innovation, support enterprises to adopt advanced technology and equipment to improve drug safety, and provide support in science and technology project approval, financing, credit, bidding procurement, price payment, medical insurance, etc. The State supports the inheritance and innovation of traditional Chinese medicine, establishes a review and approval system suitable for the characteristics of traditional Chinese medicine, and encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine. Promote the modernization and internationalization of traditional Chinese medicine. In addition, the exposure draft proposed that the drug regulatory department of the State Council should establish a system of breakthrough therapeutic drugs, conditional approval for listing, priority review and approval and special approval, encourage drug R & D and innovation, and shorten the process of drug R & D and review. Encourage the development and innovation of drugs for children In terms of drug use for children, the exposure draft proposes that the State encourages the development and innovation of drugs for children, supports the holders of drug marketing licenses to develop new varieties, dosage forms and specifications of drugs for children that meet the physiological characteristics of children, and gives priority to the evaluation and approval of drugs for children. During the period of drug development, registration and application, strengthen communication with the sponsors, promote the accelerated listing of children's drugs, and meet the clinical medication needs of children's patients. For the first approved new varieties, dosage forms and specifications for children, as well as the increase of indications or usage dosage for children, a market monopoly period of no more than 12 months shall be given, during which the same varieties shall not be approved for listing. New drugs for rare diseases shall be given a market monopoly period of no more than 7 years In terms of rare diseases, the exposure draft proposes that the State encourages the development and innovation of drugs for rare diseases, supports the holders of drug marketing licenses to carry out the development of drugs for rare diseases, encourages the development of new indications for listed drugs for rare diseases, and gives priority to the evaluation and approval of drugs for rare diseases urgently needed in clinic. During the period of drug development and registration application, strengthen communication with the sponsors, promote the listing of drugs for rare diseases, and meet the clinical drug needs of patients with rare diseases. For new drugs for rare diseases approved for listing, under the condition that the drug listing license holder promises to ensure the supply of drugs, a market monopoly period of no more than 7 years will be given, during which the same varieties will not be approved for listing. If the holder of the drug marketing license fails to fulfill the commitment of supply guarantee, the market monopoly period shall be terminated. Encourage the development of generic drugs The exposure draft also proposes that the State encourages the development of generic drugs and gives a market monopoly period to the chemical generic drugs that have successfully challenged the patent and have been approved for listing for the first time. The drug regulatory department of the State Council will no longer approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug, except for those who jointly challenge the patent. The market monopoly period shall not exceed the original patent period of the challenged drug. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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