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Standard lag
Since November 2001, the National Center for Adverse Drug Reaction Monitoring released a total of 17 "Adverse Drug Reactions Information Bulletins". Ten kinds of proprietary Chinese medicines have been notified of adverse reactions, among which there are 8 kinds of Chinese medicine injections.
According to Li Guoqing, director of the Center for Drug Evaluation of the State Food and Drug Administration, the vast majority of TCM injections were approved before the 1980s. Due to the backwardness of technology and equipment at the time, only the active ingredients could be determined and there were significant risks.
Until December 6, 2007, the State Food and Drug Administration issued the “Basic Technical Requirements for Injectables for Traditional Chinese Medicines and Natural Medicinesâ€, which strictly limits the components, raw materials, and preparation processes of traditional Chinese medicine injections. The evaluation provided the basis.
The State Food and Drug Administration carried out inspections of the production processes and prescriptions of injection drugs from August 2007 and it was basically completed by the end of 2008. According to an insider of the Food and Drug Administration, in the inspection of a pharmaceutical company, the change in the injection production process has reached 100%.
“The production process of pharmaceuticals has been changed beyond recognition by enterprises. This is too dangerous. But if it is actually produced in accordance with the approved process, it cannot be produced at all.†The insider said that re-evaluation of traditional Chinese medicine injections is not only necessary The reassessment of the safety of pharmaceuticals will also review the production process.
"We have compiled a blacklist based on recent reports." The official said that after the re-evaluation work is carried out, strict safety evaluations will be conducted on these drugs. Once unclear adverse reactions are found, companies will be faced with Revoke the fate of the production approval number.
Technical upgrade
Tu Pengfei, deputy director of the Center for the Modernization of Traditional Chinese Medicine at Peking University, believes that traditional Chinese medicine injections, as a major achievement in the modernization of traditional Chinese medicine, have high hopes but they have been unable to go abroad and cannot explain their own ingredients. Many of the ingredients in Chinese herbal medicines have not undergone rigorous pharmacological or toxicological evaluation. Chinese medicine injection directly into the blood, more likely to cause adverse reactions.
A person in charge of a pharmaceutical company stated that because the origin, growing environment, picking time, etc. of Chinese herbal medicines all affect the composition of the finished product, there will be differences in the composition of each batch, which is not entirely controllable by the enterprise in production.
"If we re-evaluate, we will certainly stop some products." The responsible person said that proprietary Chinese medicines are the only category of pharmaceutical exports in China in 2008, and now technology upgrading is the only way for companies. As China has still not introduced the technical specifications for impurities in traditional Chinese medicine injections, if it can identify the unknown ingredients, it will play an active role in the export of proprietary Chinese medicines.
In recent years, safety accidents of traditional Chinese medicine injections have caused a lot of attention. The newspaper recently learned from the State Food and Drug Administration that the Measures for the Administration of Drug Reassessment are expected to be introduced in 2009. The drug administration department will analyze and evaluate the safety of drugs according to monitoring results of adverse drug reactions and research data, and adopt appropriate risk control measures. Traditional Chinese medicine injections will become the focus of attention.