Provisions on Protection and Technology Transfer in Relation to New Drugs
Provisions on Protection and Technology Transfer in Relation to New Drugs
Provisions on Protection and Technology Transfer in Relation to New Drugs
Order of State Food And Drug Administration No.4
April 22, 1999
Chapter I General Provisions
Article 1 The Provisions are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Measures for the Examination and Approval of New Drugs and the relevant national regulations with a view to encouraging the research and development of new drugs, protecting the initiative of R&D institutions and producers in researching, developing and producing new drugs, avoiding duplication of research and production, safeguarding the order of the drug technology market and the legitimate rights and interests of both parties in the transfer of new drug technologies and promoting the development of China's pharmaceutical industry.
Article 2 The Provisions apply to the research, development and production of new types of drugs within the territory of China, including chemical medicines, traditional Chinese medicines and biological products.
Article 3 China is to implement a classification protection system for new drugs and an examination and approval system for technology transfer in relation to approved new drugs.
Chapter II Protection of New Drugs
Article 4 A new drug will be protected after the New Drug Certificate is issued by the State Food and Drug Administration (SFDA). The protection period for various classes of new drugs is as follows: 12 years for Class I new drugs, 8 years for Class 2 and 3 new drugs, and 6 years for Class 4 and 5 new drugs. For any new drug that has a trial period, the protection period shall include such trial period.
Article 5 No entity or individual shall produce a new drug which is within its protection period if receiving no technology transfer from the holder of the New Drug Certificate (Original), and no application for the examination and approval of the new drug shall be accepted by the drug regulator. For a newly discovered Class 1 traditional Chinese medicinal substance which is within its protection period, unless such medicinal substance is contained in the new drug as filed by the original development institution, the technology transfer shall be conducted as required before the filing of the new drug; otherwise, any application for such new drug will be refused.
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