Legal basis: Measures for the Administration of Drug Registration
Article 19 For a drug for which another person has obtained a patent right in China, the applicant may file an application for registration within two years before the expiration of the patent term for the drug. The State Food and Drug Administration of the United States shall conduct an examination in accordance with these Measures, and if it meets the requirements, it shall issue a drug approval number, an import drug registration certificate or a pharmaceutical product registration certificate after the patent expires.
Article 20 According to the provisions of Article 35 of the Regulations for the Implementation of the Drug Administration Law, the State Food and Drug Administration of the United States shall, within six years from the date of approval, refuse to approve the application of licensed producers or sellers to produce and sell drugs containing new chemical components using unpublished data. However, unless the applicant submits the data obtained by himself.