The new drug management law is a social hot spot

August 26, the 12th session of the Standing Committee of the 13th National People's Congress concluded in Beijing, at which it voted to adopt the newly revised Drug Administration Law. The new law will come into effect on 1 December 2019. Subsequently, the General Office of the Standing Committee of the National People's Congress held a press conference to respond to hot issues.The import of drugs from abroad is subject to approval Article 124 of the newly amended Drug Administration Law stipulates that the import of a small number of drugs that have been legally listed abroad without approval may be reduced if the circumstances are less serious; Does this provision respond to the Lu Yong case and the Liaocheng counterfeit drug case?In response, Yuan Jie, director of the Administrative Law Office of the Standing Committee of the National People's Congress, said that imports of drugs from abroad must be approved, as provided for in the newly revised Drug Administration Law. Even medicines that have been legally marketed abroad cannot be imported without approval. This time to modify the scope of counterfeit drugs, the unauthorized import of drugs from the counterfeit drugs out of the separate provisions, in response to the concerns of ordinary people, but does not mean to reduce the penalty, but strictly set legal responsibility. Those who violate the provisions of Article 124 and constitute the production, import or sale of counterfeit or inferior drugs shall still be punished according to the production, import and sale of counterfeit and inferior drugs.In order to explore the internet drug sales leave roomthe newly revised drug management law does not mention whether the network is prohibited from selling prescription drugs, the future of online drug sales how to regulate?In this regard, Yuan Jie said that in the draft law in the process of deliberation and consultation, there are two different views, some think that the direct sale of prescription drugs through the Internet should be prohibited, some suggestions that the internet can be allowed to sell prescription drugs under the premise of enhanced supervision. Comprehensive views from all sides, adhere to the same standards on-line, one-in-one supervision principle, the law on the network sales of drugs made a comparative principle of the provisions, that is, the network sales of drugs to comply with the relevant provisions of drug management, and authorized the State Council drug supervision and administration department in cooperation with the State Council Department of Health and Health and other specific formulation measures, while providing that several types of special management drugs can not be sold online, leaving room for practical exploration.Liu Pei, director of the policy and regulation department of the State Drug Administration, said the measures for the supervision and management of drug network sales are being drafted. The next step will be to speed up the drafting process with health and other sectors.Article 12 of the newly revised Drug Administration Law, which will issue technical standards for drug traceabilitystipulates that the State shall establish a drug traceability system and the drug regulatory department under the State Council shall formulate uniform standards and norms. What is the current state of work at the national level?In this regard, Liu Pei said, drug traceability system refers to the use of information technology to ensure the quality and safety of drug production and operation, to prevent counterfeit drugs, inferior drugs into legal channels, and can achieve drug risk control and accurate recall. The construction of drug traceability system to "one thing one yard, one yard with chase" as the direction, requires drug market license holders to establish a drug traceability system, to achieve the drug minimum packaging unit traceability, verifiability. The general principle of establishing the drug traceability system is that the regulatory authorities set the system, set the standard, allow multi-code co-exist, can be compatible with the original electronic supervision code, but also compatible with other codes commonly used in the international community, give full play to the main role of enterprises.The Drug Administration Law clearly stipulates that listed license holders, production and operation enterprises and medical institutions shall establish and implement a drug traceability system, and each unit shall establish its own traceability system to achieve data interconnection. As required, the State Drug Administration is in the process of establishing a retrospective collaborative platform and a retrospective regulatory platform, and will issue a series of technical standards to enable each department to have a unified traceability system standard specification.Encourage the development and innovation of children's medicinesArticle 16 of the newly revised Law on Drug Administration adds to the expression of effective measures taken by the State to encourage the development and innovation of medicines for children. What effective measures will be taken at the national level to accelerate the development of medicines for children?In this regard, Liu Pei said, because children's drugs are more special, research and development, use of drugs compared to adults are less, in the research and development process, especially to carry out clinical trials and other aspects of the more difficult, low enthusiasm for research and development. Therefore, the Drug Administration Law specifically stipulates that the State should take effective measures to encourage the development and innovation of medicines for children, support the development of new varieties, dosage forms and specifications for children's medicines that meet the physiological characteristics of children, and give priority to the review and approval of medicines for children. Next, the drug regulatory department should study the relevant supporting regulations and policies in the process of implementing the Drug Administration Law, and encourage and promote the development and innovation of children's drug use. (Health Journal)