Chinese Pharmacopoeia

Zhoufu Cheng explained that in the 2010 version of "Chinese Pharmacopoeia" in the revision and upgrade the standard work, for the same prescription, clinical efficacy of the same species of different series of dosage forms, in the implementation of standards, amend or adjust the relevant content, assignment are focal points of similar products as possible to a unit commitment of both cost and time savings, but also conducive to family unity of the standard specification. "Otherwise, different demands on the series of varieties, will lead directly to pharmaceutical manufacturing enterprises in the quality control of unfair, leading to unfair competition in the pharmaceutical market." Zhoufu Cheng said.

"Pharmaceutical standards is the embodiment of national drug development is the work of the technical basis for drug administration. To strengthen drug standard management, improve the quality of drugs, drug administration is an important aspect of the work." Zhang pointed out that in our current national drug standards, a considerable number of varieties of the standard level is not high, especially to the rise in the country is fairly conspicuous target species. Occurred in recent years, several security incidents caused by drug quality, and the State Bureau of injections carried out by prescription and process verification, all exposed parts of the standard drugs defects.

At the same time, Zhang believes that technical standards for pharmaceutical drugs is registered to carry out the technical review of scientific evidence, but also prescribes guidelines for development of reporting. At present, although there are a lot of technical standards promulgated, but the demand for drug development and the new revised "Drug Registration" demands the implementation there is a gap in comparison: first, not the early implementation of technical standards to be revised, the new " measures "in some of the requirements can not fully reflected in the technical standards; Second, technical barriers to entry are not high enough after the implementation of the assessment; Third, systematic technical standards is not strong, broad coverage is not and can not play a role as possible . Therefore, the standard raise and drug testing must be combined with the re-evaluation, to speed up drug standards to improve the implementation of the Action Plan.