Amendment of the Drug Administration Law

  • 16 Sep 2019 3:33 PM
    Message # 7882671

    Decision of the Standing Committee of the National People's Congress on the Amendment of the Drug Administration Law of the People's Republic of China (“the Decision”) was passed at the 12th conference on 26th August of 2019 by the 13th Standing Committee of the National People’s Congress and will be implemented from 1st December of 2019. The Decision has the following major amendments on the <Drugs Administration Law>:

    1. define the permit holder system for drugs administration in respect of drugs market launching. The permit holder is responsible for the safety, effectiveness and quality controllability of the drugs during the development and production, as well as the whole sales transferring process.   

    2. Except vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs and pharmaceutical-grade chemicals usable in making illicit drugs such special managed drugs defined by the state, drugs market permit holder and drugs operation enterprise may sell drugs through network.

    3. Complete drugs traceability system. It is stipulated that market permit holder, enterprises engaged in production and marketing and medical institutions should establish and implement drugs traceability system. They shall build up the traceability system by themselves respectively, providing the data is able to be interconnected. 

    4. Further improve the relevant exam and approval system to increase the exam and approval efficiency. 

    5. The right of exam and approval for the medicine import of small quantity for urgent clinical needs is devolved to provincial government. 

    The new Drugs Administrative Law takes a pragmatic approach according to the current situation but also has consideration for future possibilities. Setting drugs as base point, it upgrades the whole chain and system to give the full power of implementing the four “most” of new Drugs Administrative Law:the most rigorous standard, the strictest supervision, the sternest punishment and the most serious accountability, which further strengthen the legal system that covers the whole chain of drugs development, production, marketing and using.

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