Shanghai has introduced 25 measures to support major projects by foreign-invested biopharmaceutical companies, covering manufacturing, research and development, and headquarters operations.

The measures target projects with large investment, strong innovation capacity, and broad industry impact.

One-stop services for major projects

Industrial projects featuring advanced technologies and delivering substantial industry-wide benefits will be included on the municipal list of major foreign-invested projects and recommended for inclusion on the national lists of major and key foreign-invested projects.

Projects on the municipal list will receive coordinated one-stop services covering market access, planning, environmental reviews, land and premises, energy use, construction, foreign exchange, and import and export procedures.

Support for licensing, local production, and faster reviews

Shanghai will promote cooperation between foreign-invested companies and innovative enterprises and facilitate licensing transactions.

The city will provide coordinated support through clinical resources, shared incubator platforms, contract research and manufacturing organizations, industrial parks, and investment and financing services to help licensed projects move into production.

Imported drugs and medical devices transitioning to local production will receive end-to-end support, covering land acquisition, construction, manufacturing change applications, distribution, and sales.

Medical devices that obtain registration certificates from China's drug regulatory authorities may participate in procurement as domestically manufactured products.

The start of clinical trials will be accelerated through parallel reviews of project initiation, ethics, and contracts.

Eligible overseas drug marketing authorization holders will be supported in conducting cross-border segmented manufacturing of biological products.

For already-marketed imported products transitioning to local production, priority will be given to registration sampling and Good Manufacturing Practice compliance inspections. Registration inspections and GMP compliance inspections may be conducted concurrently.

For eligible already-marketed imported Class II medical devices and Class II medical devices transferred to production in Shanghai from other parts of China, the technical review will be completed within five working days. The average review period for first-time registration of Class II medical devices will be reduced to within six months.

Faster customs clearance and broader access

Shanghai will further integrate customs clearance and sampling services for imported drugs while providing 24-hour customs clearance.

Sampling will be carried out within three working days of arrival, and the sample volume required for each batch will be reduced from three times to twice the amount needed for full testing.

The city will also facilitate customs clearance for imported R&D items and the import and export of certain high-risk special items required for the development and production of cell therapies and in vitro diagnostic reagents.

Small quantities of clinically urgent drugs and medical devices that have obtained overseas registration certificates but not domestic registration may be temporarily imported in accordance with the law for specific medical purposes at designated medical institutions.

Eligible high-value drugs and medical devices related to high-level projects may also be supported for inclusion in commercial health insurance coverage, including Huhuibao, Shanghai's city-customized commercial supplementary health insurance plan.

Data flows, financial support, and greater opening-up

Shanghai will implement its citywide negative-list mechanism for outbound data transfers and provide foreign-invested companies with training and guidance on the lawful cross-border transfer of R&D and clinical study data.

Foreign-invested companies are encouraged to establish venture capital, technology commercialization, and private equity funds in Shanghai. They may also partner with government-backed biopharmaceutical and future-industry parent funds to establish sub-funds.

Eligible biopharmaceutical projects invested in by foreign-invested enterprises, or by enterprises in which they have reinvested in China, may qualify for tariff exemptions on imported equipment for their own use.

Foreign investors that directly reinvest distributed profits may also benefit from applicable tax credits and deferral of withholding income tax.

Under the guidance of relevant central government authorities, foreign-invested companies in the China (Shanghai) Pilot Free Trade Zone may develop and apply human stem cell, gene diagnosis, and gene therapy technologies for product registration, marketing authorization, and manufacturing.

The measures took effect upon issuance and will remain valid until June 21, 2029.

*In the event of any discrepancy, the Chinese-language policy shall prevail.

Source: Shanghai Municipal Commission of Science and Technology