New Drug Administration Law： Drugs imported without approval are not counterfeit drugs.

　　Beijing Procuratorate Daily, August 26th (Reporter Xie Wenying) "164 votes in favor and 3 abstentions". On the morning of August 26th, the 12th meeting of the 13th the National People’s Congress Standing Committee (NPCSC) voted to pass the newly revised Drug Administration Law. The highlight of the revision is that the scope of counterfeit and inferior drugs has been revised, and drugs imported without approval have not been classified as counterfeit drugs. At the same time, respond to questions such as whether the network can sell prescription drugs.

　　Because China has not implemented compulsory license, some cancer patients are still "illegally" buying foreign generic drugs to save themselves. The experience of Lu Yong, a leukemia patient in Dying to Survive, is a true portrayal of this situation. In order to alleviate the contradiction of "expensive medical treatment" among the people, and let the public use good drugs more quickly and afford good drugs, the State Council requires speeding up the examination and approval of new drugs listed overseas and strengthening the supply guarantee of drugs in short supply, which are all reflected in the newly revised Drug Administration Law.

　　Yuan Jie, director of the Administrative Law Office of the Legal Affairs Committee of the National People’s Congress Standing Committee (NPCSC), said at today’s press conference that the import of drugs from abroad must be approved, which is a rule and principle made by law. Drugs that have not been approved, even those that have been legally listed abroad, cannot be imported. This time, the scope of counterfeit and inferior drugs was revised, and drugs imported without approval were no longer classified as counterfeit drugs, which was a response to the concerns of the people. The newly revised Drug Administration Law stipulates that if the circumstances are minor, the punishment may be reduced or exempted for importing a small amount of drugs legally listed abroad.

　　"It is not the same as reducing the punishment to take drugs imported without approval out of counterfeit drugs and stipulate them separately." Yuan Jie said that the law has strictly set legal responsibilities, and the production, import and sale of counterfeit and inferior drugs without obtaining the drug approval documents are still punished according to the production, import and sale of counterfeit and inferior drugs.

　　To implement the drug administration law well, the responsibility of the regulatory authorities should not be underestimated. Yuan Jie said that in the chapter on supervision and management, it is stipulated that if the drug supervision and administration department finds that a drug violation is suspected of committing a crime, it shall promptly transfer the case to the public security organ. The public security organ, the people’s procuratorate and the people’s court shall promptly transfer the case to the pharmaceutical supervisory and administrative department if there is no need to pursue criminal responsibility or be exempted from criminal punishment according to law, but administrative responsibility should be pursued.

　　There is a high degree of social concern about whether prescription drugs can be sold online. In this regard, the newly revised Drug Administration Law also responded. Liu Pei, director of the Policy and Regulation Department of National Medical Products Administration, said that the current law clearly stipulates that prescription drugs cannot be sold directly to the public through the Internet, and the revised Drug Administration Law stipulates the principle of comparison in selling drugs through the Internet, that is, it requires the drug sales through the Internet to comply with the relevant provisions on drug management, and authorizes the drug supervision and administration department of the State Council to formulate specific measures in conjunction with the health authorities of the State Council and other departments, and stipulates that several types of specially managed drugs cannot be sold online.

　　The newly revised drug administration law will come into effect on December 1 this year.