China is seeking to improve the quality of its generic drugs with new assessment guidelines issued to pharmaceutical companies. (Photo : Twitter)
China's health authorities are seeking to improve the quality of generic drugs to be on par with branded ones with a new order issued to pharmaceutical companies.
In a circular issued earlier this week, the State Council General Office (SCGO) said that generic drugs already available in the market are to be assessed to determine whether their quality and effectiveness are at the same level as brand-name drugs, China.org reported.
The office also said that the assessment is to be done in-house by the companies, with the results identifying the medicines that have passed published by the China Food and Drug Administration (CFDA).
All of the drugs that pass the assessment will be included in the government's national insurance program, and will be prioritized in procurement to be made by public hospitals, as well as be given other benefits.
CFDA head Bi Jingquan said that the new order will undoubtedly be a challenge to drug manufacturers, but stressed that it is necessary for the country to improve its position in the global pharmaceutical market.
The order outlined several new policies in the approval of new drugs, introducing a new "prioritized" review process for particular new drug applications, Sidley reported.
Under the regulations, drugs that already have ongoing registration application in the United States and the European Union will be given the same status, provided that their production facilities have already passed on-site inspection by the two regions' drug monitoring bodies.
Priority in the application process will also be given to drugs that are to be used in the treatment of particular diseases like HIV, malignant tumors, rare illnesses and the like, as well as those that have current urgent demand.
