NOTIFICATION - World Trade Organization



NOTIFICATIONThe following notification is being circulated in accordance with Article 10.61.Notifying Member: China If applicable, name of local government involved (Article 3.2 and 7.2): 2.Agency responsible: China Food and Drug AdministrationName and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above: 3.Notified under Article 2.9.2 [X], 2.10.1 [?], 5.6.2 [X], 5.7.1 [?], other:4.Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Drugs -Medical devices5.Title, number of pages and language(s) of the notified document: Related Policies about Encouraging the Innovation of Drugs and Medical Devices and Accelerating the Review and Approval for the Launching of New Drugs and Medical Devices (Draft) (5?page(s), in Chinese) 6.Description of content: These policies aim to encourage the innovation of drugs and medical devices and accelerate?the review and approval for the launching of new drugs and medical devices.?The main content is as follows,?accelerating?the review and approval of drugs and medical devices which are?urgent for clinical use;?supporting?the research and development of drugs and medical equipment for rare diseases treatment;?stricting?the review and approval of injection;?adjusting?the management model of the pharmaceutical raw materials, excipients and packaging materials;?improving?the review system of drugs and medical devices;?supporting?the clinical application of new drugs;?as well as the inheritance and innovation of traditional Chinese medicine;?establishing?a preferential examination and approval system based on patent compulsory license?etc.7.Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety8.Relevant documents: - 9.Proposed date of adoption: To be determinedProposed date of entry into force: To be determined10.Final date for comments: 60 days after circulation by the WTO Secretariat11.Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body: WTO/TBT National Notification and Enquiry Center of the People's Republic of ChinaTel.: +86 10 84603881/84603950Fax: +86 10 84603811E-mail: tbt@aqsiq. ................
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