The most stringent "Drug Administration Law" will come into effect on December 1st! Counterfeit and inferior drugs are redefined by "4+7"

On July 1, 2018, the movie "I'm not the God of medicine" was released In the movie, "the God of medicine" seeks "fake medicine" for cancer patients What's the crime? Trigger all kinds of nerves After 20 days, Zhai Yiping, who suffered from liver disease, bought anticancer drugs from Germany, sold to domestic patients through QQ and other channels, was sentenced to three years' imprisonment, three years' probation and a fine of 30000 yuan In February 2019, Chen Zongxiang, chief physician of Liaocheng Tumor Hospital, recommended "cabotinib" for cancer patient Wang Da Ye, who was not approved for listing in China After the patient died, his family members had disputes with the hospital Among them, the definition of "cabotinib" and "fake medicine" caused extensive discussion in the society All the controversies focus on the collision between reality and law in purchasing anti-cancer drugs on behalf of others In response to social concerns, on August 26, 2019, the newly revised Drug Administration Law of the people's Republic of China was voted and adopted at the 12th meeting of the Standing Committee of the 13th National People's Congress, in which the definition of fake drugs and substandard drugs was redefined At the same time, the punishment for fake drugs was also increased unprecedentedly The new law will be formally implemented on December 1, 2019 Fake drugs and substandard drugs are redefined by "4 + 7" In the new drug administration law, "fake drugs" are defined as four situations of small weight loss and seven situations of substandard drugs becoming plump Shao Rong, a professor at China Pharmaceutical University, summed up in an interview In the new drug administration law, Article 98 of Chapter 10 redefines fake drugs and substandard drugs: production (including preparation, the same below), sale and use of fake drugs and substandard drugs are prohibited Under any of the following circumstances, it is a fake drug: (1) the ingredients contained in the drug do not conform to the ingredients specified in the national drug standards; (2) the drug is passed off as a non drug or another drug; (3) the drug is deteriorated; (4) the indications or functional indications indicated in the drug are beyond the specified range Comparison of the new and old version of drug regulatory law (source: GMP Office) Note: the blue font is the deleted part, and the red font is the added part Highlight analysis: compared with the new version and the old version of the drug administration law, we can see that there are two cases in which the old version is defined as the nature of fake drugs; in addition, there are six cases that are treated as fake drugs, while the new version cancels the six cases in which the old version was treated as "fake drugs", of which two cases directly rise to the nature of "fake drugs" Under any of the following circumstances, it shall be considered as inferior drug: (1) the content of drug ingredients does not conform to the national drug standards; (2) the contaminated drug; (3) the drug that does not indicate or change the period of validity; (4) the drug that does not indicate or change the batch number of the product; (5) the drug that exceeds the period of validity; (6) the drug that adds preservatives or auxiliary materials without authorization; （7） Other drugs that do not meet the drug standards At the same time, it is prohibited to produce or import drugs without obtaining drug approval certificates; it is prohibited to use APIs, packaging materials and containers that are not reviewed and approved in accordance with regulations to produce drugs Comparison of the new and old version of drug regulatory law (source: GMP Office) Note: the blue font is the deleted part, and the red font is the added part It can be seen that after the redefinition of fake drugs and substandard drugs, the drugs that have not been approved for import are no longer listed as fake drugs In addition, Article 124 of the newly revised Drug Administration Law stipulates that for a small number of drugs that have not been approved for import and are legally listed abroad, if the circumstances are relatively minor, they can be mitigated or exempted from punishment This means that many cases like "I am not the God of medicine" will not need to be put on criminal record The most stringent regulatory law in history "although the law separately regulates the drugs imported without approval from fake drugs, it does not mean that the punishment is reduced, but the legal liability is strictly set." Liu Pei, director of the Department of policies and regulations of the State Food and drug administration, stressed at a press conference that "the import of drugs from abroad must be approved, which is a rule and principle Without approval, even drugs that have been legally marketed abroad cannot be imported " The newly revised Drug Administration Law is also known as the most severe punishment law in history, which is mainly reflected in the following aspects: improving the range of property punishment The amount of fine for the production of counterfeit drugs has increased from two to five times the value of the original illegal production and sale of drugs, to 15 to 30 times the value of the original illegal production and sale of drugs, and it is stipulated that if the value of the goods is less than 100000, it shall be calculated as 100000; that is to say, the minimum fine is 1.5 million yuan The fine for the illegal act of producing and selling inferior drugs has also increased from one to three times the value of the goods to ten to twenty times the value of the goods The strength of qualification punishment has been increased The qualification penalty for the person responsible for the illegal act of fake and inferior drugs has been raised from ten-year prohibition to life-long prohibition The enterprises whose production and sales of fake drugs have their licenses revoked will not accept their corresponding applications within ten years Increase the means of free punishment On the basis of traditional punishments such as warning, fine, confiscation, suspension of production and business, revocation of license and prohibition of employment, administrative detention is introduced as a personal freedom punishment The enterprises that violate the law seriously shall be punished to people The implementation of the "double punishment system" will further strengthen the punishment of the legal representative, the main person in charge, the directly responsible person in charge and other responsible personnel of the enterprise on the basis of the punishment of the illegal enterprise The methods of punishment include forbidding employment, confiscating the illegal income, imposing a fine, revoking the practice certificate, etc Emphasis on regulatory responsibility Governments at all levels, drug supervision and administration departments, and competent departments of health and health shall cooperate in accordance with the division of responsibilities If the supervision department has dereliction of duty and dereliction of duty in investigating and punishing the illegal acts of fake and substandard drugs, the competent department directly responsible and other responsible personnel shall be given heavier punishment according to law Improve the civil liability system The victim may demand punitive compensation for an enterprise that produces fake medicines or knowingly sells and uses fake medicines "The former" fake drugs "were determined by whether the drugs had been approved, but ordinary people often judge whether the drugs are true or false, whether they can cure the disease and save people, and whether they have any effect." Lu Yong, the prototype of the movie "I am not the God of medicine", said in an interview that the new law seamlessly connects ordinary people's understanding of "fake medicine" with the judicial definition of "fake medicine", which makes him feel that the revision of the law is serious and conform to the public opinion And the most severe punishment law let us see the determination of the state to safeguard people's life and health, let us feel the awe of "law" and "life" In the view of Professor Shaorong of China Pharmaceutical University, enterprise production and operation should consider the plot and consequences in the administrative responsibility Only in the high-voltage line, more "self-discipline and compliance", can the industry be more standardized, and can the industry be a hundred years old Surnames provide safer and more reliable medicines Article reference: 1 GMP office "drug management law" old and new version comparison, and official interpretation!!! 2 Exclusive interview with Chinese businessmen: Lu Yong's law revised several years ago, I am not the God of medicine will not be released 3 Where are the "four strictest" reflected in the newly revised Drug Management Law reported by the people's court? 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