The Law of the People's Republic of China on the Administration of Drugs?(hereinafter referred to as the "Drug Administration Law") was revised and passed by the 12th?Session of the 13th?National People's Congress Standing Committee on August 26, 2019 and came into force on December 1, 2019.?The System for Drug Listing Permit Holder?is one of the focuses of this reform and it stipulates:
Any enterprise or drug research institution that holds the drug registration certificate (drug approval number, import drug registration certificate, and pharmaceutical product registration certificate) can be the holder of the drug listing permit and shall strictly fulfill its obligations as the holder of the drug listing permit, and shall be responsible for the safety, effectiveness, and quality controllability of drugs in the whole process of drug research, production, management, and use according to law.
It is understood that the System for Drug Listing Permit Holder?is currently an internationally accepted drug administration system, which has been implemented in developed countries or regions such as the European Union, the United States, Japan, etc. In addition, the system has great policy guiding significance for drug research&development and production.
Hemony Pharmaceutical Co., Ltd.
Hemony Technological Park
On November 29, Hemony holds a special training meeting on System for Drug Listing Permit Holder. Luo Yongqiang, Director of Quality Management Department, is invited to the meeting as the training lecturer. Director Luo explains the content of the system after reform and its impact on the company's business development in detail from the background and significance of the system reform.
Luo Yongqiang, Director of Quality Management Department
Analysis on essentials of System for Drug Listing Permit Holder
1. Subject qualification of drug listing permit holder
According to the provisions of Article 30 of the new Drug Administration Law, an enterprise or drug research institution may apply for the drug listing permit. Therefore, the subject of drug listing permit holder will not be limited to drug production enterprises, and enterprises or drug research institutions without production capacity can also apply for the drug listing permit.
2. Transfer of drug listing permit
According to the provisions of Article 40 of the new Drug Administration Law, with the approval of the drug regulatory department under the State Council, the drug listing permit holder can transfer the drug listing permit. This is the first time in China that the drug listing permit can be transferred as the transaction object.?The drug listing permit holder can transfer drug-related rights and interests through the transfer of assets, which is conducive to the optimal allocation of resources and reduces the duplicate construction.
3. The drug listing permit holder will be responsible for the quality and risk management during the whole life cycle of drugs
According to the provisions of Article 30 of the new Drug Administration Law, drug listing permit holder shall be responsible for non-clinical research, clinical trial, production and operation, post-listing research, adverse reaction monitoring, reporting and handling of drugs in accordance with the provisions of this Law, which puts forward higher requirements on the responsibilities and management capabilities of drug listing permit holder.
According to the current drug regulatory system, China adopts a decentralized multi-link risk prevention?&?control and commitment mechanism for the regulation in drug field, namely that multiple subjects manage drug research, production, sales and other activities in a segmented manner and assume drug responsibilities for their respective corresponding links. After the implementation of the new Drug Administration Law, drug regulation will focus on drug listing permit holder, who will be responsible for the unified management of all links in the whole life cycle of the drugs.
4. Responsibilities and obligations fulfilled by the drug listing permit holder on drug administration
1) Establishment of quality assurance system
2) Rules for public release of drug listing permit holder
3) Drug listing permit holder shall establish the drug traceability system
4) Annual reporting obligations of drug listing permit holder
5) Risk management after drug listing
6) Joint liability of domestic enterprises and holders of overseas drug listing permits
7) Everyone shall perform the drug quality assurance responsibility