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	NOTICE OF THE DRUG REGISTRATION DEPARTMENT OF THE STATE FOOD AND DRUG ADMINISTRATION ON USING ANTI-HIV MEDICINE TO UNDERTAKE TESTS ON BIO-EQUIVALENCE OF HUMAN BODY

	(Letter No. 133 [2003] of the Drug Registration Department of the State Food and Drug Administration promulgated on September 10, 2003)


SUBJECT : DRUG; ANTI-HIV MEDICINE
ISSUING DEPARTMENT : THE STATE FOOD AND DRUG ADMINISTRATION
ISSUE DATE : 09/10/2003
IMPLEMENT DATE : 09/10/2003
LENGTH : 472 words
TEXT :

In order to implement the State Council's "China HIV/AIDS Containment, Prevention and Control Action Plan (2001-2005) ", this Administration has taken active measures to rapidly approve the applications for the registration of the medicines used to treat, prevent and diagnose AIDS on the premise that "the procedures shall not be simplified, the standards shall not be lowered, the safety and effectiveness of the medicines should be guaranteed, and their quality should be controlled". At present, the zidovudine, stavudine, didanosine and nevirapine, which are under application by some domestic enterprises, have been approved to register, put into production and sell in the market.

The domestically oriented production of anti-HIV medicine has changed the situation that these medicines used for clinical purposes were mainly imported, thus the treatment expenses of the patients are reduced. In order to further guarantee the quality and effectiveness of the anti-HIV medicine, if to produce any anti-HIV medicine that has been sold in a foreign market, the test on bio-equivalence of the human body still needs to be undertaken. We hereby give our notice as follows regarding the relevant matters:

I. Any enterprise that has obtained the approved registration number for an anti-HIV medicine shall, when producing this kind of medicine, undertake a test on bio-equivalence of the human body by regarding the imported medicine of the same variety as the reference preparation. Such tests shall be undertaken by the production enterprises upon their discretional selection of a clinical pharmacology base. Within six months as of the promulgation of the present Notice, the test documents shall be submitted to the Acceptance Office of this Department.

II. With respect to an anti-HIV medicine for which the new medicine certificate has been obtained, but the approved medicine registration number has not been obtained yet, the applicant shall, when applying for the transfer of the new medicine technology, provide the documents of the test on bio-equivalence of the human body, undertaken by the transferee by regarding the imported medicine of the same variety as the reference preparation.

The responsibility to evaluate the above documents of the test on bio-equivalence of the human body shall remain with the Center for Drug Evaluation under the State Food and Drug Administration, and the Center shall report the evaluation result to this Department.

III. If any anti-HIV medicine under evaluation meets the requirements, this Department will, in the form of "Approval Document on Clinical Research of Medicine", demand a test on bio-equivalence of the human body, which the imported medicine of the same variety is regarded as the reference preparation. After the test is finished, the applicant shall submit documents in accordance with the "Measures for the Administration of Drug Registration".

Annex: Approval Document on Clinical Research of Medicine (Omitted)