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    Home > Active Ingredient News > Drugs Articles > Three years later, perhaps a group of pidomode delisted?

    Three years later, perhaps a group of pidomode delisted?

    • Last Update: 2018-03-21
    • Source: Internet
    • Author: User
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    [policies and regulations of China Pharmaceutical network] on March 20, 2018, the State Food and Drug Administration issued two consecutive documents on pidomode One is sfjgh [2018] No 31 notice of the General Administration on the initiation of clinical effectiveness test of pidomode oral liquid, and the other is sfjgh [2018] No 32 notice of the General Administration on matters related to pidomode preparation One of the two documents is for domestic production, the other is for import In general, the General Administration of food and drug administration has responded to the strong response of some doctors in the medical field and the public, urged the production enterprises of pidomode preparation or oral liquid to comply with the relevant provisions of the drug administration law of the people's Republic of China, started the clinical effectiveness test as soon as possible, and reported the evaluation results to the drug evaluation center of the State Food and drug administration within three years Seeing this result, I feel relieved Before that, the public opinion about pidomode, the "paediatric drug", was well known The reason is that in December 2017, pharmacist Ji Lianmei published an article, "please let go of the Chinese children, who sell 4 billion pidomode a year!" Ji Lianmei pointed out in the article that pidomode is still in the stage of mice in foreign medical clinical trials, and the efficacy is not clear, but it has become an expensive "God drug" in China It is abused in pediatrics in various hospitals, and the sales volume is expected to reach 4 billion yuan She suggested that the relevant departments reevaluate the clinical efficacy of pidomode This article broke the hearts of parents, the effectiveness and safety of pidomode can not be proved? Can the doctor and manufacturer who prescribes the medicine give a statement? Since then, the "magic medicine" pidomode has been in constant trouble Before long, the pidomode manufacturer responded The company issued a media statement saying that the effectiveness and safety of drugs have been proved and will be further explained for the Chinese market The strong reflection of the society soon attracted the attention of the general administration The author's knock on the blackboard! This paediatric "magic medicine" is forbidden for children under 3 years old! 》According to the article, on March 9 of this year, the State Food and Drug Administration issued a notice on Revising the instructions of pidomode preparation (No 30, 2018) According to Announcement No 9, in order to further ensure the safety of drug use by the public, the State Food and drug administration has decided to revise the instructions of pidomode preparations (including pidomode tablets, pidomode powder, pidomode dispersible tablets, pidomode oral solution, pidomode oral solution, pidomode capsule and pidomode granules) It is pointed out in the announcement that all pidomode preparation manufacturers shall, in accordance with the measures for the administration of drug registration and other relevant regulations, submit supplementary applications for the revision of pidomode preparation specification template, and report to the provincial food and drug regulatory authorities for filing before April 30, 2018 At the same time, it is pointed out that if the revised contents involve drug labels, they shall be revised together; other contents of the instructions and labels shall be consistent with the original approved contents Replace all drug instructions and labels that have been delivered within 6 months after the supplementary application is filed From the announcement of the revision of the instructions of pidomode preparation to the present, the supervision and production enterprises have conducted and submitted the effectiveness test within three years The industry said that three years later, there may be a number of pidomode delisting In addition, in the Circular of the General Administration of the people's Republic of China on matters related to pidomode preparation (sfjgh [2018] No 32), the list of pidomode preparation varieties (made in China) is attached The attachment is as follows:
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