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根据《药品管理法》第二十一条“国家鼓励研究、创制新药”以及《新药审批办法》的有关规定,为保护科研、生产单位研制新药的积极性,促进新药的发展,特作如下规定:一、新药经卫生部审核批准后,即发给研制单位“新药证书”正本和副本,该副本可用于新药的技术转让.二、凡卫生部批准的新药,其他单位如未得到原研制单位的技术转让,在以下时限内不得移植生产:自颁发“新药证书”之日起,第一类新药八年(含试产期二年);第二类新药六年(含试产期二年);第三类新药四年;第四类新药三年.
According to the relevant provisions of Article 21 of the Drug Administration Law, “State encourages research, creation of new drugs” and “Measures for the Examination and Approval of New Drugs”, in order to protect the enthusiasm of scientific research and production units in developing new drugs and promote the development of new drugs, the following special provisions shall be made: 1. After the approval of the new drug by the Ministry of Health, the original and the copy of the “new drug certificate” issued to the developer unit will be issued and the copy may be used for the technology transfer of the new drug. 2. Where the new drug and other units approved by the Ministry of Health have not obtained the The transfer of technology shall not be transplanted for production within the following time-limits: the first category of new drugs shall be eight years (including the trial production period of two years) from the date of the issuance of the “New Drug Certificate”; the second category of new drugs shall have six years (including the trial production period of two years) ; Third new drug four years; fourth new drug three years.