Market News | HKTDC Hong Kong International Medical and Healthcare Fair

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Trade Actions Could Result from Effort to Lower Drug Prices
May 2025

President Trump issued on 12 May an executive order promising “aggressive action” if foreign countries and manufacturers do not lower prices for prescription drugs in the U.S.

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More Unannounced Inspections at Foreign Food and Medical Facilities
May 2025

In a move that the FDA said “marks a new era in FDA enforcement,” the agency has announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for U.S. consumers and patients.

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China Launches Pilot for Use of Imported Calculus Bovis in Production of Proprietary Chinese Medicine
May 2025

On 21 April, the National Medical Products Administration and the General Administration of Customs jointly announced the launch of a pilot programme for the use of imported calculus bovis in the production of proprietary Chinese medicines in 12 provincial-level regions, namely, Beijing, Tianjin, Hebei, Shanghai, Zhejiang, Jiangxi, Shandong, Hunan, Guangdong, Sichuan, Fujian and Guangxi. Under this programme, calculus bovis sourced from countries or regions not subject to mad cow disease import bans and compliant with China’s customs quarantine and pharmaceutical quality inspection requirements will be permitted for trial use in the manufacturing of proprietary Chinese medicines. The programme will continue for two years and the use of imported calculus bovis will be progressively expanded nationwide after two years upon evaluation. Applicants for the import of calculus bovis should be drug marketing authorisation holders for proprietary Chinese medicines containing calculus bovis. Detailed requirements are outlined to ensure the quality and safety of calculus bovis, the traceability of imports, and the integrity of processing and production procedures.

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Trump Announces Additional Actions Involving Medicines, Biological Research and Movies
May 2025

President Trump on 5 May issued two executive orders aimed at promoting the domestic production of critical medicines and improving the safety and security of biological research. In addition, the president has instructed senior officials to immediately begin the process of instituting a 100 percent tariff on foreign movies.

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Shenzhen Entrusted to Exercise Provincial-Level Administrative Duties in Hetao Shenzhen Park
May 2025

In order to speed up the development of the Shenzhen Park area of the Hetao Shenzhen-Hong Kong Science and Technology Innovation Co-operation Zone (Hetao Shenzhen Park) into an “international high ground” for science and technology innovation, the Guangdong provincial government announced on 18 April its decision to entrust Shenzhen to exercise eight provincial-level administrative duties in relation to the Hetao Shenzhen Park. The administrative duties that will be undertaken by competent departments in Shenzhen include approvals for the purchase of narcotic drugs, psychotropic drug preparations, and standard and reference materials for teaching and research purposes; filings for internet information services for drugs and medical devices; issuance of free sales certificates for Category II and Category III medical devices; issuance of free sales certificates for drugs; filings for patent attorney practices; filings for branches of patent agencies; permits for auctioning business; and professional qualification certification for registered architects (for change of registration and deregistration of Class 1 registered architects only).

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China Issues Registration Requirements for Traditional Chinese Medicines from Hong Kong and Macao
May 2025

On 18 April, the National Medical Products Administration’s Center for Drug Evaluation issued an announcement on reporting and technical requirements for registration on the Mainland, under streamlined procedures, of Hong Kong and Macao-registered proprietary Chinese medicines for oral use. According to the announcement, which took immediate effect, documentation to be submitted by applicants include administrative documents, pharmaceutical information, documents supporting the marketing of the drug, inserts and packaging labels. Administrative documents include explanatory statements, application forms, materials for the approval of generic drug names, certification documents for medicine ingredients, pharmaceutical excipients and packaging materials, patent information and certificates, approvals for the marketing and sale of drugs, and the credentials of applicants/manufacturers in the Hong Kong and Macao Special Administrative Regions. Pharmaceutical information includes details of medicinal ingredients used, assessment of medicinal resources and techniques for the concoction and preparation of medicines, information on the quality of pharmaceutical preparations, and details on packaging, storage and the validity period of the drugs concerned.

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Mexico Updates Good Manufacturing Practices for Medical Devices
May 2025

Mexico has updated its mandatory standard on good manufacturing practices for medical devices, with the new requirements effective from 30 November.

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Guangdong Rolls Out 30 Tax Measures to Facilitate Modern Industrial Development
Apr 2025

On 21 March, the Guangdong Provincial Tax Service unveiled 30 tax measures geared towards facilitating a modern industrial system. The measures aim to stimulate the drive for science and technology innovation through implementing preferential tax policies such as a lower income tax rate for high-tech enterprises and value added tax refunds for the purchase of domestic-made equipment by R&D institutions. They are also designed to strengthen emerging future industries and give rise to taxation systems and collection and administration measures suited to various industries. Qualifying modern service enterprises in Hengqin and Nansha are eligible for a reduced enterprise income tax rate of 15%. Traditional industries will also be helped to undergo transformation and upgrading. Steps will be taken to enhance the alignment of tax regulations in Guangdong, Hong Kong and Macao in a bid to optimise the regional industrial structure. Industrial openness and co-operation will be deepened by helping “going out” businesses and individuals to better understand the tax policies of their investment destinations and implementing “refund-upon-departure” measures for cross-border e-commerce exports to overseas warehouses. Preferential tax policies and services will also be offered to attract high-calibre talents.

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China Optimises QR Code Information Management for Drug Production Licences
Apr 2025

On 7 April, the National Medical Products Administration (NMPA) unveiled measures for the optimisation of QR Code information management for drug production licences. As stipulated by the NMPA, original and duplicate copies of Drug Production Licences issued after 1 July 2025, whether in paper or electronic form, must include the corresponding QR codes. Information regarding production authorisations, changes, commissioning/acceptance of commission, and other related details, must be uploaded to the NMPA’s Drug Production Licence management module within five working days after completion of the relevant tasks. Starting from 1 January 2026, basic information about companies, their workshop and production line status, commissioning data, changes to their records, and other relevant information should be accurately displayed upon scanning of their QR codes. Furthermore, the information shown must be updated in a timely manner to ensure accuracy. Except for first-time licence applications, paper copies, both original and duplicate, no longer require repeated updates, provided that such updated information can be accessed through QR code scanning.

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Shenzhen Rolls Out 32 Measures for Development of Drugs and Medical Devices
Apr 2025

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.

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