Laws of the People's Republic of China

RULES GOVERNING THE APPROVAL OF CLINICAL TRIAL
OF FOREIGN DRUG(S)

  (Promulgated by the Ministry of Public Health
of the People's Republic of China on February 2, 1988)

 

 

 

SUBJECT: PHARMACEUTICS & HEALTH

ISSUING-DEPT: MINISTRY OF HEALTH

ISSUE-DATE: 02/02/1988

IMPLEMENT-DATE: 02/02/1988

LENGTH: 1104 words

TEXT:

[Article 1] All foreign pharmaceutical manufacturing enterprises which want to conduct clinical trial of a foreign drug in this country shall submit a written application in compliance with the "Rules Governing the Registration and Clinical Trial of Foreign Drug(s) in China" to the Bureau of Drug Administration of the Ministry of Public Health for approval.

[Article 2] When applying for clinical trial, the applicant shall indicate clearly the purpose of the trial and shall furnish with the application the following data:

(1) Documents certifying the registration and/or approval of clinical trial of the said drug(s) in the country to which the applicant affiliates, or, in other country or region;

(2) Documents certifying the manufacturer of the said drug(s) is in compliance with the requirements of the Good Manufacturing Practice (GMP);

(3) Technological data on:

(a) name (including its commercial name, INN and chemical name), composition, dosage form, name and structure of its active ingredients, and literatures justifying the structure;

(b) its sources and manufacturing process;

(c) experimental data of its stability;

(d) quality standards and analytical procedures;

(e) data on its pre-clinical pharmacological, toxicological and pharmacokinetic studies, (for biologicals, data on the strain and its specific characteristics of the micro-organism, on its safety and immuno/genicity, etc);

(f) data of clinical trial already conducted previously outside this country;

(g) its description and sample, and

(h) other data as deemed necessary.

(4) oroposed procedure for the clinical trial to be conducted in this country.

The documents as listed above shall be submitted along with an abstract or summary in the Chinese language.üü However, a full Chinese translation text is required for the description of the quality standards and the application as well as for the proposed procedure of the clinical trial to be conducted in this country.

[Article 3] Clinical trial of any foreign drug(s), if approved to be conducted in this country, shall be performed by the hospital and/or the clinical pharmacological institution as designated by the Bureau of Drug Administration of the Ministry of Public Health.üü The applicant is entitled to propose the participating institution(s) for the clinical trial subject to the approval of the Bureau of Drug Administration of the Ministry of Public Health.

[Article 4] The applicant may propose the number of cases as required for the clinical trial.üü However, in the event of applying for the "Import Drug Permit" through undertaking registration in this country, and then, more than 50 cases are required (not including those in the control group) if the said drug(s) has been registered in the country or area to which the applicant affiliates; more than 100 cases are required (not including those in the control group) if the said drug(s) has been registered in country or area other than the one to which the applicant affiliates; and more than 300 case are required (not including those in the control group) if no registration has been made whatsoever.üü Special arrangement shall be made to number of cases required for drug(s) for specific disease.

[Article 5] The Bureau of Drug Administration of the Ministry of Public Health shall inform the applicant and participating institution(s) upon approval of the clinical trial and the designation of clinical institution(s) performing the clinical trial.üü The Bureau of Drug Administration of the Ministry of Public Health is to designate an unit to negotiate and to sign the contract, on behalf of the institution(s) performing the clinical trial, with the foreign enterprise(s), and to collaborate with the Bureau of Drug Administration of the Ministry of Public Health in the organization, coordination and administrative services of the clinical trial.

[Article 6] Applicant shall provide, free of charge, sample drug(s) (including reference substance and regagent) for clinical trial, and shall attache thereto a report indicating the fulfillment of quality standards of the said drug(s).üü Any new drug, if it has not been registered in the country or region to which the applicant affiliates, shall be subject to the test performed by instittuion of drug control of this country for approval before clinical trial.

[Article 7] Applicant shall make due amount of payment convering the cost of conducting clinical trial for each specific kind of drug to a specific number of cases.üü The actual amount of payment shall be decided upon through consultation between the applicant and the unit as designated by the Bureau of Drug Administration of the Ministry of Public Health.üü If the test is to be performed by the institution of drug control of this country, due amount of payment shall be made in accordance with the provisions of the "Rules Governing the Rate of Payment for the Approval, Control and Test of Drugs".

[Article 8] In accordance with the guiding principal of clinical trial set forth by the Ministry of Public Health of this country and taking into account of the requese as raised by the applicant, the institution(s) responsible for the technical aspects of clinical trial shall formulate a plan of action for the clinical trial, and submit to the Burein of Drug Administration of the Ministry of Public Health for the record before its implementation.

[Article 9] In the course of clinical trial, the clinical institution(s) shall put the users under close observation and ensure their safety.üü The applicant shall be responsible for any possible adverse consequence arising from the drug(s), and shall make due compensation for any possible losses arising therefrom.

[Article 10] The clinical institution(s) shall, upon the completion of clinical trial, report its findings to the Bureau of Drug Administration of the Ministry of Public Health, and send a copy to the applicant.

[Article 11] If a Chinese institution needs to conduct clinical trial on a foreign drug for medical or scientific research purposes (the number of cases shall not exceed 20), the institution may submit an application accompanied with the documents as listed in Article 2 of this Rules to the Bureau of Drug Administration of the ministry of Public Health for approval.

[Article 12] The authority to interpret this Rules is vested with the Bureau of Drug Administration of the Ministry of Public Health.

[Article 13] This Rules shall come into force on the date of promulgation.