- 10
- 20
- 30
On 7 April, Shenzhen’s Development and Reform Commission and three other government departments in the city jointly announced 32 measures to support the development of drugs and medical devices in the city. The measures entered into force on 2 April and will remain active for three years. Efforts will be redoubled to support fundamental research by increasing capital investment in Shenzhen Medical Research Fund projects, and also to speed up the commercialisation of scientific research into start-up projects. The application of artificial intelligence in biomanufacturing and medical device research and development (R&D) will be promoted, while the establishment of Greater Bay Area (GBA) international clinical trial centres will be accelerated. In addition, review and approval guidance services will be strengthened by adding more qualified institutions to the list of designated healthcare institutions that are allowed to use certain Hong Kong/Macao-registered drugs and medical devices. Manufacturing of innovative medical devices and an expansion of the market for such devices will also be supported, and the industry’s international development will be enhanced through assistance to medical device companies in their cross-border technology licence transactions, cross-border R&D efforts, and more.
The U.S. has initiated separate Section 232 investigations on the national security effects of imports of (i) semiconductors and semiconductor manufacturing equipment, as well as their derivative products, and (ii) pharmaceuticals and pharmaceutical ingredients. Additionally, a separate proceeding will soon be launched on processed critical minerals and their derivative products. These investigations could result in the establishment of additional tariffs and other import restrictions on these products.
Hong Kong has the highest life expectancy in the world thanks to its advanced healthcare services. In addition, the city expects to be home to an increasingly aging population, as is the case with many other developed economies, in the years to come. The number of elderly people aged 65 or above is projected to increase from 20% of the total population in 2021 to 32% by 2041.
On 25 March, the National Medical Products Administration announced that the 2025 edition of the Pharmacopoeia of the PRC will enter into force on 1 October. All marketing authorisation holders and all drugs produced and marketed must comply with the publication’s requirements. Assessments must be made on whether or not drug registration standards meet the relevant standards of the pharmacopeia’s new edition. If changes need to be made to the drug registration standards, supplementary paperwork should be submitted before the date of implementation of the new edition so that changes can be made according to requirements. If the changes involve drug prescriptions, production technologies, raw materials, excipients or packaging materials and containers in direct contact with drugs, verification must be carried out in accordance with the requirements of the Measures for the Administration of Drug Registration, the Administrative Measures for Drug Post-Marketing Changes (For Trial Implementation), and relevant technological and quality management specifications. Changes will be implemented after record-filing.
On 20 March, the State Council released guidelines to improve the quality of Chinese medicine and promote the Chinese medicine industry’s high-quality development. These call for greater efforts to protect and utilise Chinese medicine resources, develop systems for ecological planting and breeding, improve circulation and reserves, and accelerate the industry’s transformation and upgrading. These efforts are expected to optimise the overall structure of the Chinese medicine industry, improve the quality of medicines manufactured, and foster high-quality varieties and brands. Efforts will also be made to enhance preparation and usage of Chinese medicine. Science and technology innovation will be promoted to build research and development capacity, strengthen quality control, improve standards and supervision, and promote opening up and development in the industry.
On 18 March, the National Medical Products Administration announced and put into practice a raft of measures to optimise the domestic production of “imported” medical devices. The announcement broadens the eligibility criteria for domestic manufacturing of such devices. Previously, only foreign-invested enterprises directly established by original registrants were eligible. The updated policy now includes “enterprises that share the same actual controller as the original registrant”. Documentation requirements for registration have also been refined. If the applicant and registrant are the “actual controller”, they must explain and provide documentary proof of equity relationships. Furthermore, inspection requirements under the registration system have been optimised. Besides verification of an applicant’s status, attention is paid to the actual equivalence between domestic and imported quality management systems at the time of a product’s design and development. Priority will be given to the registration and issuance of production permits for the domestic manufacture of imported innovative medical devices.
On 26 March, the government of Hainan province and the government of the Hong Kong Special Administrative Region signed a Memorandum of Co-operation in Boao in a move aimed at helping the two places combine their advantages, deepen economic and trade exchanges, and consolidate industrial and supply chains to promote economic and trade integration between China and ASEAN (the Association of Southeast Asian Nations). The two sides agreed to deepen collaboration in areas such as medicine, finance and trade, tourism and culture, and data services. Companies from the Hainan Free Trade Port are encouraged to issue bonds in Hong Kong, while high-quality companies from the Hainan Free Trade Port will be given support in getting listed in Hong Kong. The safe and orderly flow of data will allow the two sides to co-operate in promoting data services. Support will be given to Hainan’s tourism industry to commence joint international marketing efforts and jointly develop products for multi-destination tourism in collaboration with Hong Kong’s travel trade and aviation sector. Under the framework of the CEPA Agreement on Trade in Services, steps will be taken to expand opportunities for Hong Kong’s professional services sector while lifting standards of internationalisation in Hainan’s. Support will also be given to major economic sectors, state-owned enterprises and institutions in the Hainan Free Trade Port to recruit the services of Hong Kong professionals or institutions.
The Key Points and Determination Principles for Clinical Trials of Medical Devices has been revised by the National Medical Products Administration, with a view to better regulating clinical trials and inspections of such devices. Details are available in an announcement issued by the NMPA on 12 March and the updated guidelines will take effect on 1 May.
