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.
China Briefing is published by Asia Briefing, a subsidiary of Dezan Shira & Associates. We produce material for foreign investors throughout Asia, including ASEAN, India, Indonesia, Russia, the Silk Road, and Vietnam. For editorial matters please contact us here, and for a complimentary subscription to our products, please click here.
Dezan Shira & Associates is a full service practice in China, providing business intelligence, due diligence, legal, tax, IT, HR, payroll, and advisory services throughout the China and Asian region. For assistance with China business issues or investments into China, please contact us at email@example.com or visit us at www.dezshira.com
Dezan Shira & Associates is a pan-Asia, multi-disciplinary professional services firm, providing legal, tax and operational advisory to international corporate investors. Operational throughout China, ASEAN and India, our mission is to guide foreign companies through Asia’s complex regulatory environment and assist them with all aspects of establishing, maintaining and growing their business operations in the region. This brochure provides an overview of the services and expertise Dezan Shira & Associates can provide.
This Dezan Shira & Associates 2017 China guide provides a comprehensive background and details of all aspects of setting up and operating an American business in China, including due diligence and compliance issues, IP protection, corporate establishment options, calculating tax liabilities, as well as discussing on-going operational issues such as managing bookkeeping, accounts, banking, HR, Payroll, annual license renewals, audit, FCPA compliance and consolidation with US standards and Head Office reporting.
China’s foreign investment landscape has experienced pivotal changes this year. In this issue of China Briefing magazine, we examine how foreign investors can capitalize on China’s latest FDI reforms. First, we outline new industry liberalizations in both China’s FTZs and the country at large. We then consider when an FTZ makes sense as an investment location, and what businesses should consider when entering one. Finally, we give an overview of China’s latest pro-business reforms that streamline a wide range of administrative and regulatory measures.