Laws of the People's Republic of China

PROVISION FOR THE ISSUANCE OF THE IMPORT DRUG PERMIT

  (Promulgated by the Ministry of Public Health of the People's
Republic of China on June 8, 1987)

 

 

SUBJECT: PHARMACEUTICS & HEALTH

ISSUING-DEPT: MINISTRY OF HEALTH

ISSUE-DATE: 06/08/1987

IMPLEMENT-DATE: 06/08/1987

LENGTH: 667 words

TEXT:

[Article 1] With a view to strengthening the control of importing drugs and promoting the development of international trade in pharmaceuticals, and in the light of the relevant provisions of the "Drug Administration Law of the People's Republic of China" and the "State Provisions for Quality Control of Import Commodities", it has been decided to implement a permit system for the control of importing drugs and to promulgate this "Provisions for the Issuance of the Import Drug Permit".

[Article 2] Before the import of any drugs, the "Import Drug Permit" (hereinafter referred to as the "Permit") shall be first applied for, in accordance with this Provision, to the Ministry of Public Health of the People's Republic of China.

[Article 3] Following data and documents shall be submitted when applying for the Permit:

(1) Duplicate and its Chinese translation copy of the certificate issued by the health authorities of the exporting country ratifying the production, marketing and export of the drug(s) concerned;

(2) Letter of patent;

(3) Data sheets and its Chinese translations;

(4) Technical information:

(i) Formula, names (including non-proprietary name, trade name, chemical name) of active ingredients, vehicles and preservatives;

(ii) Brief description of its production process;

(iii) Specifications and quality control methods for the drug(s);

(iv) Experimental and literature data on its pharmacology and toxicology;

(v) Clinical data, including its indications, dosage, route of its administration, incompatibility with other medicines, adverse reactions and sideefects, contraindications and precautions;

(vi) Data on its stability studies.

(5) Samples of the drug(s), and

(6) Packaging materials and samples of the label.

[Article 5] Drug(s) imported for the first time shall be subject to clinical validation shall be subject to approval by the Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China.

[Article 6] When a foreign manufacturer or its agent applies for a Permit, an "Application Form" (as attached to this Provision) shall be completed, in duplicate, and submitted, with all data and documents as so required, to the Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China, or, to the Bureau through the departments or bureaux of public health of provinces, municipalities or autonomous regions.

[Article 7] The Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China is to examine all data and documents as submitted, and, upon the approval of the application, notify the foreign manufacturer or its agent in China to apply for the Permit, each of which costs US $ 500 - 1,000.

[Article 8] A Permit is valid for four years as of the date of its issuance. All foreign manufacturers and their agents may apply for renewal six months before expiration. The application for a renewal shall be submitted to the Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China. No data or documents is required to be submitted in this case.

[Article 9] In case of any revision and/or supplement to the specification, indication and precaution, etc, of the imported drug(s), the manufacturer shall report and submit in time the updated data and information to the Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China.

[Article 10] If any problem arises in the clinical use of the imported drugs, the manufacturer and/or the clinical institution shall report in time to the Bureau of Drug Administration of the Ministry of Public Health of the People's Republic of China, or to the department or bureau of public health of the respective province, municipality or autonomous region.

[Article 11] This Provisions shall come into force on the date of its promulgation.