Major Breakthrough | China’s National Medical Products Administration potentially to grant new rare disease drugs market exclusivity for up to seven years
On May 9, 2022, the National Medical Products Administration (NMPA) of China released the "Regulations for the Implementation of the Drug Administration Law of the People's Republic of China (Draft Revision for Comments)."
In respect to pediatric drugs, the draft proposed that the first new molecular entities (NMEs), dosage, and formulations approved for marketing for pediatrics, as well as those drugs adding indications or increasing dosage for pediatrics, should be granted a makert exclusive period for a maximum of no more than 12 months, during which the period drugs of the same entity will not be approved for marketing.
In respect to rare diseases, the draft proposed that the new drugs for rare diseases approved for marketing should be granted a market exclusivity period of no more than seven years, during which the period durgs of the same entity will not be approved for marketing, as long as the drug marketing license holder agrees to ensure supply of the drug in this period. If the drug marketing license holder fails to fulfill the supply guarantee commitment, the market exclusivity period shall be terminated.
Excerpt of provisions related to the rare disease:
Chapter II Drug development and registration
Article 9 [to encourage innovation] China will improve the drug innovation system, support basic research, applied research, and original innovation of drugs, promote the clinical value-oriented drug innovation, and support enterprises to use advanced technology and equipment to improve their drug safety. China will support science and technology projects, financing, credit, bidding and procurement, prices of payment, health insurance, and other fields. In addition, China will support enterprises to set up or jointly set up R&D institutions, encourage enterprises to cooperate with higher education institutions, research institutes, medical institutions, etc. to carry out research and innovation of drugs, reinforce the protection of intellectual property rights of drugs, and improve the ability to innovate drugs independently.
Article 10 [to speed up the marketing] NMPA will establish breakthrough therapeutic drugs, conditional approval for marketing, priority review and approval, and special approval system to encourage drug R&D and innovation, and shorten the process of drug R&D and review. In addition, NMPA shall clarify the scope, procedures, supporting policies, and other requirements to support eligible drugs to speed up their marketing.
Article 23 [overseas data acceptance] If the applicant's clinical trial data is obtained outside the country and meets the requirements NMPA, it can be used for drug marketing license applications. If foreign companies carry out the international multi-center drug clinical trials in China meets the relevant requirements, the clinical trial data can be used for drug marketing license applications.
Article 28 [pediatric drugs] China encourages the R&D and innovation of pediatric drugs and supports the development of drug marketing license holders to develop NMEs, dosage and specifivations of drugs for pediatrics that meet the physiological characteristics of children and give priority to the review and approval of these drugs. In addition, during the drug R&D and registration filing, China will strengthen communication with the sponsors, promote the accelerated marketing of drugs for pediatrics, and meet the clinical needs of pediatric patients.
For the first approved NME, dosage, and formulations for pediatrics, as well as the increase of indications or dosage for pediatrics, China will grant a maximum of 12 months of market exclusivity period, during which the same entity of drug will not be approved for marketing.
China encourages applicants to submit R&D plans of dosage, formulations and usage for pediatrics when submitting drug marketing authorization applications.
Article 29 [rare diseases] China encourages the R&D and innovation of drugs for rare diseases, supports the development of drugs for rare diseases by the holder of the drug marketing license, encourages the development of new indications for marketed drugs for rare diseas, and give priority to the review and approval of rare disease drugs for urgently clinical needs. In addition, during drug R&D and registration filing period, China will strengthen communication with the sponsors, promote the marketing of rare disease drugs, and meet the clinical drug needs of patients with rare diseases.
For new drugs approved for marketing for rare diseases, a period of market exclusivity of up to seven years shall be granted to the holder of the drug marketing license under the condition that the holder undertakes to guarantee the supply of the drug, during which period drugs in the same entity will not be approved for marketing. If the drug marketing licensee fails to fulfill the supply guarantee commitment, the market exclusivity period will be terminated.
Article 40 [Data Protection] China will protect the undisclosed test data and other data of those drugs approved for marketing. Any party, other than drug marketing license holders, shall not use the undisclosed test data and other data for improper commercial use. Within six years from the date of the drug registration certificate secured by the holder of the drug marketing license, if other applicants use the data in the preceding paragraph to apply for drug marketing liscense without the consent of the holder of the drug marketing license, NMPA shall not approve the application; except that other applicants submit their own data obtained. The drug supervision and regulatory authority shall not disclose the data specified in the first paragraph of this article, except in the following circumstances: (a) the public interest requires; (b) applicants have taken measures to ensure that such data will not be used improperly for commercial purposes.
Chapter VII Guarantee of drug supply
Article 117 [measures to guarantee the supply of drugs in shortage] China will establish a supply guarantee system for those drugs in short supply and supply guarantee fund for those drugs.
China will establish and perfect national monitoring and early warning system for drug shortage, and collects information on drug R&D, production, circulation, and use. Drug marketing license holders, drug manufacturers, drug companies, and medical institutions shall report the relevant information as required.
China will respond to and handle the shortage of drugs based on levels and categories according to the reasons for the shortage. China will encourage the R&D and production of drugs in short supply. In respect of those drugs in short supply for urgent clinical needs and other new drugs for the prevention and treatment of major infectious diseases and rare diseases, China will prioritize their review and approval.
The People's Republic of China Drug Administration Law Implementation Regulations (Draft Revision for Public Comments)" full-text link: https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20220509222233134.html
About CANbridge Pharmaceuticals Inc.
CANbridge Pharmaceuticals Inc. (HKEX:1228) is a China-based global biopharmaceutical company committed to the research, development and commercialization of transformative therapies for rare disease and rare oncology. CANbridge has a differentiated drug portfolio, with three approved drugs and a pipeline of 11 assets, targeting prevalent rare disease and rare oncology indications that have unmet needs and significant market potential. These include Hunter syndrome and other lysosomal storage disorders, complement-mediated disorders, hemophilia A, metabolic disorders, rare cholestatic liver diseases and neuromuscular diseases, as well as glioblastoma multiforme. CANbridge is also building next-generation gene therapy development capability through a combination of collaboration with world-leading researchers and biotech companies and internal capacity. CANbridge global partners include: Apogenix, GC Pharma, Mirum, Wuxi Biologics, Privus, the UMass Chan Medical School and LogicBio.
For more on CANbridge Pharmaceuticals Inc., please go to: www.canbridgepharma.com.
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