Our clear quality and curative effect of generic drugs to achieve consistent with the original drug

Source: xinhua

Author: Wang Sibei

Time: 2016-03-07

In order to promote the overall level of China's pharmaceutical industry, ensuring drug safety and effectiveness of the state council general office recently issued by the quality of the implementation of generic drugs and curative effect evaluation of consistency opinions, require chemicals new registered classification approval prior to implementation of generics, who is not in accordance with the principle of in line with the original drug quality and curative effect of examination and approval, shall be in consistency.

According to introducing, generic drugs is with the original drugs with the same active ingredients, dosage forms and ways of drug delivery and therapeutic effect of drugs. Most of the drugs for generic drugs in our country, at present, the basic meet the requirements of the public administration, and generic drugs but also faced with generics are of variable quality, low standard of generic, such problems as part of the drug efficacy is not exact.

"For generic drugs already approved for quality and consistency of curative effect evaluation, this is history lesson. In the past we approved medicines with no compulsory requirements of the original drug quality consistency evaluation of curative effect, so some drugs on the curative effect with the original drugs exist some gaps." State food and drug supervision bureau, bi jingquan, said the quality and consistency of curative effect evaluation, is required to have approval of generic drugs, on the quality and curative effect with the original drugs can be consistent, can be substituted with the original drugs in clinic, it helps to save the medical expenses of the society.

Jingquan, points out that advice has been clear about the consistency evaluation of main body is the enterprise, enterprise should actively look for product reference preparations, the method of research and clinical trials in accordance with the regulations. Government must to coordinate product reference preparations of recognition, evaluation method and data declaration, evaluation, and to give guidance to the work. To use in clinical and medical insurance policy support.

Opinion also demanded that the national basic drugs directory (2012 edition) on October 1, 2007 approved chemicals generics, oral solid preparations should be completed by the end of 2018 the consistency evaluation. Chemical classification of new registered other approved prior to implementation of generic drugs, over varieties through consistency evaluation after the other drug manufacturing enterprises of the same variety in principle should be completed within 3 years consistency evaluation; Fails to complete, and shall not be registered.

"To carry out the drug quality and consistency of curative effect evaluation is a huge challenge to the enterprise." Jingquan said, but the work to improve the quality of the development of pharmaceutical industry, for really the pharmaceutical industry in our country from pharmaceutical giants to pharmaceutical power, real drugs can enable our preparations towards the international market, is crucial. (source)