The Measures is part of the framework of China's Drug Patent Linkage System. The system aims to bridge the marketing approval of generics and the patent protection of brand-name drugs.
The Measures' main contents are as follows:
System for Platform Development and Information Publication
System for Patent Registration
Patent Statement System for Generic Drugs
System of Jurisdiction Linkage and Administration Linkage
System of Stay Period for Approval
Classification System for Dealing with Drug Reviews and Approvals
System of Marketing Exclusivity Period for First Generics (The first generic in China refers to the first generic drug products manufactured and marketed domestically. The exclusivity is only applicable to the first generics that successfully challenge the valid patents, not to the first generics that get marketing approval after the corresponding patents expire)
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