Article 24No pharmaceutical preparations dispensed by medical institutions may be marketed or marketed in disguised forms, nor may any advertisement of such pharmaceutical preparations be released.

When major disasters, epidemic situations or other emergencies occur, or there is urgent need clinically but no supply of the needed drugs in market, the pharmaceutical preparations dispensed by a medical institution may be used by other designated medical institutions within a specified time limit, upon approval by the drug regulatory department under the State Council or by the drug regulatory department of the people's government of a province, autonomous region and municipality directly under the Central Government.

Transfer allocation and use of special pharmaceutical preparations regulated by the drug regulatory department under the State Council, and the transfer allocation and use of pharmaceutical preparations dispensed by medical institutions among provinces, autonomous regions, or　municipalities directly under the Central Government shall be subject to the approval by the drug regulatory department under the State Council.

Article 25Pharmacy personnel of medical institutions who check and dispense prescriptions shall be the pharmaceutical technicians whose qualifications are legally recognized.

Article 26When purchasing drugs, medical institutions shall keep authentic and complete records. In the purchase record shall be indicated the adopted name of the drug in China, dosage form, strength, batch number, date of expiry, manufacturer, supplier, purchase volume, purchase price, date of purchase and other items specified by the drug regulatory department under the State Council.

Article 27Drugs provided to patients by the medical institutions shall be within the scope of diagnoses and treatments and dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.

The scope of drugs purchased and provided to patients by family planning technical service institutions shall be in conformity with the scope of services approved and the drugs shall be dispensed according to the prescriptions of licensed doctors or licensed assistant doctors.

The out-patient departments, clinics and other medical institutions, which are set up by individuals, may not purchase or provide drugs other than those commonly used and those for emergency treatment. The range and category of the drugs commonly used and those for emergency treatment shall be determined by the local administrative department for health of the people's government of the province, autonomous region, or municipality directly under the Central Government together with the drug regulatory department at the same level.

Chapter V Control over Drugs

Article 28The institutions for non-clinical safety evaluation and study of drugs shall implement the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP) and the institution for drug clinical trial shall implement the Good Clinical Practice (GCP). The GLP and GCP shall be formulated by the drug regulatory department under the State Council through respective consultation with the administrative department of science and technology under the State Council and the administrative department for health under the State Council.

Article 29Clinical trials, manufacturing and importation of drugs shall be in conformity with the provisions in the Drug Administration Law and in the Regulations, and shall be reviewed and approved by the drug regulatory department under the State Council. The drug regulatory department under the State Council may authorize the drug regulatory departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government to conduct site inspection of research and development conditions of the drugs being applied, to conduct procedural examination of submitted documents, and to test the pilot samples. The specific measures therefor shall be formulated by the drug regulatory department under the State Council.

Article 30Any clinical trial to be conducted for research and development of a new drug shall be subject to the approval by the drug regulatory department under the State Council in accordance with the provisions in Article 29 of the Drug Administration Law.

When the application for conducting clinic trials is approved by the drug regulatory department under the State Council, the applicant shall select institutions for clinical trials from the lawfully certified ones to conduct the trials, and report the selected institutions to the drug regulatory department and the administrative department for health under the State Council for the record.

Prior to the drug clinical trial, the institution for drug clinical trial shall provide the subjects or their legal guardians with the truthful information on the trial, and a written informed consent shall be obtained.

Article 31For production of a drug admitted by national drug standards, an application shall, in accordance with the provisions of the drug regulatory department under the State Council, be submitted to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government or to the drug regulatory department under the State Council, and the relevant technical data and supporting documents shall be provided. The drug regulatory department of the people's government of the province, autonomous region and municipality directly under the Central Government shall, within 30 working days from the date it receives the application, review and make comments, and report the matter to the drug regulatory department under the State Council for review while notifying the applicant of its comments. If all the requirements are fulfilled upon review, a drug approval number shall be issued by the drug regulatory department under the State Council.

Article 32Where a drug is produced according to an interim standard, an application shall be submitted for formalization of the standard three months prior to the expiry date of the interim standard according to the provisions of the drug regulatory department under the State Council; the drug regulatory department under the State Council shall, within 12 months from the expiry date of the interim standard, review and approve the interim standard as formal one if it fulfills the requirements for the formalization set forth by the drug regulatory department under the State Council. Where an applicant does not make such an application or the original interim standard fails to fulfill the requirements for the formalization, the drug regulatory department under the State Council shall withdraw the interim standard and the approval number for drug production issued on the basis of the said interim standard.

Article 33For alteration of any items indicated in the approval documents and their attachments for new drug research and development, production or importation of a drug, a supplementary application shall be submitted to the drug regulatory department under the State Council; if all the requirements are fulfilled upon the review, an approval shall be given by the drug regulatory department under the State Council.