(Approved by the State Drug Administration on December 6, 2002, promulgated by Order No. 36 of SDA on December 13, 2002, put into effect as of January 15, 2003 and abolished by the Order No. 11 on Jul. 13, 2004)

Content: These Measures are formulated to ensure the safety and efficiency of biological products in accordance with the Pharmaceutical Administration Law of the People’s Republic of China and its Implementing Rules. For the purpose of the Measures, the approval and licensing of biological products refers to the system of compulsorily examination, inspection, and approval of each sale by manufacturing enterprises and of each import of vaccine products, blood products, in vitro biological diagnosis reagents for use in haematogenous checks, and of other biological products designated by the State Drug Administration (SDA). Any biological product that requires approval and licensing but fails to meet the requirements for either shall be prohibited from import, use, or sale. The catalogue of biological products subject to the approval and licensing requirements will be formulated and published by the SDA.

• CHAPTER I     General Provisions
• CHAPTER II    Application
• CHAPTER III   Checkup, Inspection and Approval
• CHAPTER IV    Review
• CHAPTER V     Penalty
• CHAPTER VI    Supplementary Provisions