Chapter X

Testing for Drug Registration

Article 128 Testing for drug registration consists of sample testing and verification of specifications.

Sample testing refers to the testing of samples conducted by a drug testing institute according to the specifications submitted by an applicant or checked by the State Food and Drug Administration.

Verification of specifications refers to the laboratory testing and review conducted by a drug testing institute on the feasibility and scientific basis of the testing methods and the controllability of the set items and indicators of drug quality in the submitted specifications.

Article 129 The National Institute for the Control of Pharmaceutical and Biological Products or the drug testing institutes of the provinces, autonomous regions, and municipalities directly under the Central Government shall take charge of the testing for drug registration. The National Institute for the Control of Pharmaceutical and Biological Products shall arrange testing for import drug registration.

Article 130 The testing for registration of the following drugs shall be conducted by the National Institute for the Control of Pharmaceutical and Biological Products or the drug testing institutes designated by the State Food and Drug Administration:

(1) drugs prescribed in subparagraph (1) and (2) of Article 45 of the Provisions;

(2) biological products and radioactive pharmaceuticals; and

(3) other drugs specified by the State Food and Drug Administration.

Article 131 Where a drug is permitted entering a special review and approval procedure, the drug testing institute shall give priority to sample testing and specification verification.

Article 132 A drug testing institute engaged in testing for drug registration shall, in compliance with the requirements set forth by the Good Laboratory Practice of drug testing institute and national metrology accreditation, have qualified personnel and adequate equipment, and comply with the quality assurance system and technical requirements of the testing for drug registration.

Article 133 An applicant shall provide the relevant data, samples and reference standards, or assist in sampling, which are required for the testing for drug registration. The amount of samples shall be three times the amount used for testing and, for biological products, manufacturing record for the relevant batches of products shall also be provided.

Article 134 While verifying the specifications of a new drug, the drug testing institute shall, in addition to sample testing, give verification opinions in respect of the specifications and test items, etc., of the drug referring to the study data, the specifications of the same kind of products at home and abroad and relevant requirements.

Article 135 Where the specifications are required to be reestablished, the applicant shall not entrust the drug testing institute that gave verification opinions to conduct the specification study of the drug; and the drug testing institute shall not accept such entrustment.