State Food and Drug Administration: enterprises will stop production if they do not have the ability to extract traditional Chinese Medicine

After nearly 8 months' consultation, the detailed rules on the regulation of Chinese herbal extraction and its supervision were officially released The management regulations focus on three points: the enterprises that produce Chinese patent medicines must have their own extraction workshop and corresponding production capacity; cancel the entrusted processing; the enterprises that record the extracts will no longer issue the drug production license, and the extracts of traditional Chinese medicine will no longer be managed according to the approval number The State Food and Drug Administration said that the extraction and extraction of traditional Chinese medicine is the premise and material basis to ensure the quality of traditional Chinese medicine is controllable, safe and effective Due to the problems in the extraction or outsourcing of traditional Chinese medicine extracts, the quality and safety of traditional Chinese medicine has brought hidden dangers From January 1, 2016, all the production enterprises of traditional Chinese medicine without the extraction capacity of traditional Chinese medicine will stop the production of corresponding varieties At the same time, for the extracts of traditional Chinese medicine that do not belong to the record management, it is required to extract them by themselves An insider from a pharmaceutical company in Shenzhen said that since the entrusted processing is a common phenomenon in the industry, the cancellation of the entrusted processing has a greater impact on the industry "Now the State Administration has stopped the examination and approval of the entrusted processing of traditional Chinese medicine extraction The approved entrusted processing has given a buffer period, which will continue until the end of 2015 In addition to the company (Group), the complete cancellation of entrusted processing is of great significance for product quality control and supervision " It is worth noting that compared with the previous draft, the formal management regulations clearly stated that the extract of traditional Chinese medicine would no longer be managed according to the approval number (except for the effective ingredients and parts of traditional Chinese medicine approved according to new drugs) It is understood that for a long time, some pharmaceutical enterprises have been unable to produce because they do not have the approval number for the production of traditional Chinese medicine extracts Some of them have the number, some have small output, and some do not This also causes the commissioned processing to become a common phenomenon in the industry The release of approval number management can not only encourage the enterprises with ability to extract by themselves, but also alleviate the impact of stopping the entrusted processing.