China Will Launch New GMP
COLUMN:PHARMACEUTICALS AND BIOCHEMICALS
China Will Launch New GMP
In a press conference on June 25th, 2010 China's State Food and Drug Administration (SFDA) spokeswoman Yan Jiangying said that a new version of "Good Manufacturing Practices" (GMP) will soon be issued and implemented.
Ms. Yan said that the new edition of the GMP puts forward specific requirements on raw materials, workshops, equipment, sanitation, personnel training and quality management that are needed for the production of pharmaceuticals.
On June 25th, SFDA also issued the 2009 drug abuse monitoring report. The report shows that the abuse of state-controlled medical narcotics such as heroin decreased, but the abuse of state-controlled psychotropic drugs such as amphetamine grew, and as a result, the overall abuse of state-controlled medical narcotics and psychotropic drugs remained unchanged.
In 1992, China established its drug abuse monitoring system. Now, China has established a drug abuse monitoring network covering the whole country and achieved the real-time and on-line report of monitoring data. The drug abuse monitoring system has set up a drug abuse risk warning report for the use of medical narcotics, psychotropic drugs and non-controlled drugs to prevent the epidemic abuse of these drugs.
Ms. Yan said in the next step, SFDA will expand and adjust the objectives and substance of China's drug abuse monitoring program and refine the evaluation methods for the dependence, abuse potential and abuse risks of medical narcotics and psychotropic drugs.
The 2010 version "Pharmacopoeia of the People's Republic of China" (the Chinese Pharmacopoeia) has been issued by the Chinese Ministry of Health and will take effect on October 1st, 2010. On June 28th, on matters relating to the implementation of the Chinese Pharmacopoeia, SFDA pointed out that if the standards for registered drugs do not meet the requirements of the Chinese Pharmacopoeia, pharmaceutical manufacturers should put forward supplementary applications according to related provisions of "Measures for the Administration of Drug Registration."
Pharmaceutical manufacturers should change specifications and labels of their pharmaceuticals according to the amendments of the Chinese Pharmacopoeia and related regulations and procedures of SFDA. From October 1st, 2010 on, pharmaceuticals makers must use the modified specifications and labels for their drugs. For drugs whose common names have been revised, their original names can be used as former names.
On June 24th, China's National Development and Reform Commission announced the pharmaceutical industry's economic data in the first 5 months of the year. From January through May, the total output value of the pharmaceutical industry was RMB437.28 billion, up 26.41% year on year, among which the output value of chemical drugs was RMB223.08 billion, up 21.57%, and the output value of biological and biochemical products was RMB95.11 billion, up 27.71%; and the export value of chemical drugs was RMB24 billion, up 28.14%, and that of biological and biochemical products was RMB5.998 billion, up 38.92%.