Registration of Drugs and Medical Devices Adjusted, Supply Chain Innovation Promoted – China Regulatory Brief
China to adjust registration management for drugs and medical devices
To promote the adjustment of industrial structure and technological innovation in the drug and medical device sector, the Communist Party of China’s Central Committee and the State Council jointly released a guideline on the reform of the review and approval system, which came into effect on October 8, 2017.
The guideline lays out several primary objectives. These include overhauling the management of clinical trials, accelerating the drug and medical device approval process, promoting drug innovation and the development of generic drugs, enhancing the administration of drug and medical devices throughout the product life cycles, and improving technical review infrastructure for greater transparency and oversight.
Notably, the guideline stipulates that qualified overseas clinical trial data can now be used in the drug and medical device registration and approval process. In the face of a grave threat to public health, drug and medical device registration approvals shall be fast-tracked. In addition, a rare disease catalogue will be set up and new products that can treat these rare diseases could be eligible for reduced trials.
The guideline was based on the China Food and Drug Administration (CFDA)’s policy proposal published in May 2017. Following the release of this guideline, the CFDA released a decision to adjust the registration of imported drugs, explicitly permitting phase I clinical trials to be carried out in China. Previous requirements that imported drugs used in the clinical trials must be registered abroad or have been used in the phase II or III trials have been scrapped.
With more measures on drug and medical device registration reform coming out, such as the new Medical Device Classification Catalogue, China’s life science industry is expected to grow more competitive and dynamic in the near future.
State Council promotes supply chain innovations and application
China’s State Council recently issued the Guideline on Promoting Supply Chain Innovations and Application.
According to the guideline, China aims to develop new supply chain technologies and models to form an “intelligent” supply chain network that will cover all key industries. And by 2020, China will support and foster around 100 leading supply chain companies that are competitive in the world.
To achieve this, the guideline sets out six measures: establishing an agricultural supply chain system by setting up tracing mechanism for key products; developing collaborative manufacturing and service-oriented manufacturing to make supply chains transparent and intelligent; using advanced theories and technologies to improve the efficiency of the supply chain; providing financial services for supply chains; promoting green manufacturing in supply chains; and adapting China’s supply chain system to the global supply chain network.
The guideline also puts forward solutions to problems in supply chain development, such as talent shortages and a patchy regulatory system. A series of supply chain innovation pilot programs are expected to be established during the reform process.
China to further develop its foreign-related legal service sector
To implement the Opinions on Developing the Industry of Foreign-related Legal Services released in January 2017, China’s Ministry of Justice recently issued a notice to launch a pilot program allowing domestic law firms to hire foreign legal counsels.
According to the notice, law firms in Beijing, Shanghai, and Guangdong can apply to participate in the pilot program by meeting certain qualifications, including having operated in China for at least three years, having more than 20 full-time practicing lawyers on staff, and having received no administrative penalties in the last three years.
The notice also laid out the requirements for the legal counsels. Generally, foreign counsels should be non-Chinese citizens who have been practicing law outside of China for at least three years. The foreign counsels should have no criminal record and have never been punished for violation of profession ethics. Further, the foreign counsels must comply with the visa requirements for foreign employees.
After a record-filing process initiated by the qualified domestic law firm, the foreign counsels can provide consulting services and agent services (except litigation) on application of foreign laws. To be noted, however, foreign counsels are still not allowed to practice Chinese law or be the partners in the law firm. In addition, representatives of foreign law firms’ representative offices in China cannot apply the pilot foreign counsel program.
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