The SFDA requires the public disclosure of the components of toxic decoction pieces

According to the voice of China News vertical and horizontal report, "attacking poison with poison" is one of the important means of treating diseases in traditional Chinese medicine, but the "toxic side effects" caused by the same toxic ingredients have also been criticized There has been a long-standing dispute over whether toxic ingredients can be used and whether they should be noted Neither side of the debate can persuade the other Recently, the State Administration of food and Drug Administration issued the notice on Revising the specifications of Chinese patent medicines containing toxic Chinese herbal pieces, which requires that the warning words of toxic Chinese herbal pieces must be added, and the varieties of Chinese patent medicines involving state secret technology cannot be spared After the notice was issued, it caused a wide discussion in the industry Compared with the shock of the new regulations on public opinion, both drug companies and regulatory departments have shown extraordinary calm In fact, this is not the first time that "toxic ingredients" have to be written in black and white, the head of the Department of pharmaceutical and chemical supervision of the food and Drug Administration explained to voice of China Person in charge: the first is that the prescription contains 28 pieces of Chinese herbal medicine made of toxic herbs collected in the order No 23 of the State Council of that year (measures for the administration of toxic drugs for medical use), including the processed products containing toxicity For this type of Chinese patent medicine, the name of the toxic pieces of Chinese herbal medicine is required to be marked under the "composition" in the manual, and the corresponding position is highlighted to increase the police Sign language It's not the first time we've asked for a sign, it's just that we've emphasized it here In 2006, when order 24 was implemented, it was clear that the ingredients should be marked The "Order No 24" issued by the drug regulatory department is the "Regulations on the administration of drug instructions and labels" implemented since 2006 The second chapter of the provisions specifies that the drug description shall list all the active ingredients or all the traditional Chinese medicine taste in the formula; if there are ingredients or auxiliary materials that may cause serious adverse reactions in the drug prescription, they shall be explained; the drug description shall fully contain the adverse reaction information and specify the adverse reactions in detail In other words, order 24 requires that all ingredients of the drug be listed, which is further upgraded in the amendment notice Person in charge: This is related to the safety of traditional Chinese medicine, including the further understanding of the safety In order to better remind the medical workers and patients, this piece has made such a requirement, which is actually an emphasis Zhao Xianhong, head of brand Department of Tongrentang Group, has more experience in the changes brought by the new and old regulations Zhao Xianhong: at the time of order 24, all the adverse reactions were marked clearly (for the unclear ones), you can write "not clear yet" This time, it's really a specific and detailed regulation The State Administration of food and drug administration also said that "indication of instructions" is only the first step In the future, enterprises will also be required to actively track the drug safety situation and update the instructions Person in charge: (drug manufacturer) shall actively track the safety of drug clinical application, and timely supplement and improve the instructions including "precautions" and a series of safety contents according to the adverse reaction monitoring data and relevant safety data reported in the literature The understanding of the toxicity of traditional Chinese medicine is constantly improving The manual needs to be overhauled, and may need to be repaired constantly For traditional Chinese medicine enterprises, this is almost a change in the rules of the game Under the pressure, Tongrentang shows a sense of relief Zhao Xianhong: it's necessary You know better In the first half of this year, these things have been going on for many days It is necessary for the State Food and drug administration to issue this regulation Since these ingredients are contained in traditional Chinese medicine, some of them were not labeled in the past, it is necessary to ensure that patients know about them or use them more safely and reasonably Zhao said Tongrentang has started to prepare the revision of the manual The acceptance date of this big test is December 31 this year Zhao Xianhong: we are studying the implementation plan There are six articles in the notice issued by the State Administration of food and drug administration, of which the third one is only one sentence, but it is particularly striking: the specifications of Chinese patent medicines involving state secret technology shall be revised in accordance with the above requirements "Secret" and "traditional Chinese medicine", many people turn their eyes to Yunnan Baiyao Like Tongrentang, Yunnan Baiyao has long been one of the biggest targets in the industry Similarly, Li Jin, technical quality director of Yunnan Baiyao group, is far less active Li Jin: the relevant national regulations and requirements are complied with by the company Specifically, we are doing according to the corresponding requirements There is a special article in it: the specifications of Chinese patent medicines involving state secret technology shall also be revised according to the requirements Will this be more difficult for our enterprise? Li Jin: as I said just now, we must comply with the regulations of relevant government departments Famous Chinese medicine enterprises have been shot this year because of the production of Chinese patent medicines containing toxic decoction pieces, but the ingredients of toxic decoction pieces have not been informed In the face of notification requirements, whether the attitude of each pharmaceutical enterprise is positive or not can not affect the change of rules Industry insiders pointed out that the State Administration of food and drug requires the modification of the specification of Chinese patent medicine containing poison, which can calm the misunderstanding of Chinese patent medicine containing poison in the international community on the one hand, and remind such enterprises to pay close attention to the adverse reactions of Chinese patent medicine containing poison on the other hand In the interpretation of the new regulations by public opinion, the most prominent one is that the toxic side effects "are not clear yet" will become history In this regard, sun Jianning, a member of the National Pharmacopoeia Committee and the leader of the key disciplines of pharmacology of traditional Chinese Medicine issued by the State Administration of traditional Chinese medicine, said that it was unfair to identify the unspecified side effects as the commonness of all traditional Chinese medicines and proprietary Chinese medicines Sun Jianning: in general, the old instructions are not available, but in case of an event, such as Houttuynia, at that time, the 2 ml intramuscular injection of Houttuynia was first closed and then opened, and the instructions that came out at this time all have warning words After labeling "toxic ingredients", whether the drug users will equate "toxic" with "harmful" is a hidden worry that the Chinese medicine enterprises have not said to export In the field of traditional Chinese medicine, this is an incredible problem Sun Jianning: it must be so There are more than 70 toxic traditional Chinese medicines in our Pharmacopoeia, but they are very commonly used in clinic In addition, many drugs use its toxic components to produce specific pharmacological effects, which may not necessarily be "toxic" or unnecessary This is not the case A similar view was expressed by the head of the Department of pharmaceutical and chemical supervision of the food and drug administration Person in charge: it doesn't mean that the toxic component is the harmful component It has its positive side and may have some side effects We make such a request based on the current monitoring results of adverse reactions Now that it can stand scrutiny, why not just write down all the possible side effects in the manual? Sun Jianning: Generally speaking, we need to publish the adverse reactions of drugs and have a formal report, and the report identification must be caused by this drug The situation of traditional Chinese medicine is very complex It is different from chemical medicine Chemical medicine has a single structure and clear code There are many cases now, but I don't know if they are caused by this drug In the absence of clear evidence, they are all written as "not clear yet" But slowly, "adverse reactions" should include some adverse reaction reports provided by clinical and adverse reaction center, and this work is being done gradually.