China

The National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), is the primary regulatory authority responsible for the oversight of pharmaceuticals, medical devices, diagnostics, and digital health products in China. The principal governing legislation includes the Drug Administration Law (revised 2019), the Regulations on the Supervision and Administration of Medical Devices (revised 2021), and supporting departmental rules issued by NMPA and the National Health Commission (NHC). The general approval process requires product registration, technical review by the Center for Drug Evaluation (CDE) for pharmaceuticals or the Center for Medical Device Evaluation (CMDE) for devices, followed by administrative approval by NMPA. Products are classified by risk tier, with Class III medical devices and innovative drugs subject to the most rigorous pre-market review pathways.

Key submission requirements include the mandatory appointment of a China-domiciled legal agent or local subsidiary as the Marketing Authorization Holder (MAH), a framework formally established under the 2019 Drug Administration Law. Dossiers for pharmaceuticals generally follow the Common Technical Document (CTD) format aligned with ICH guidelines, as China became a full ICH member in 2017 and has progressively adopted ICH E6, M4, and related guidelines. For medical devices, submissions must conform to NMPA-specific technical guidance documents. Notable recent reforms include the accelerated Priority Review and Approval (PRA) pathway for innovative and urgently needed drugs, the Conditional Approval mechanism for rare disease and oncology products, mutual recognition of overseas clinical trial data under defined conditions, and the integration of real-world evidence frameworks to support post-market regulatory decisions.

Public procurement in China operates through a centralized and tiered structure coordinated across national, provincial, and municipal levels. At the national level, the National Healthcare Security Administration (NHSA) governs reimbursement policy and leads the National Centralized Drug Procurement (NCDP) program, commonly referred to as volume-based procurement (VBP) or the '4+7' and subsequent expanded tender rounds. These centralized tenders leverage consolidated demand across provinces to negotiate steep price reductions in exchange for guaranteed volume commitments, and have been extended beyond generic pharmaceuticals to cover medical devices including coronary stents, orthopedic implants, and in-vitro diagnostics. Provincial health commissions and hospital procurement offices manage local tenders for products not yet included in national rounds, while the Government Procurement Law and relevant NHSA regulations govern transparency and competition requirements. Inclusion on the National Reimbursement Drug List (NRDL) or the National Medical Insurance Device Catalog remains a critical gateway for achieving meaningful public-sector market access.

The private healthcare sector in China is substantial and growing, encompassing private hospital chains, retail pharmacy networks, and direct-to-hospital sales channels that operate outside the VBP framework and offer comparatively higher pricing flexibility. Multinational and domestic companies often pursue a dual-track strategy targeting both public procurement lists and private-pay segments. China does not rely significantly on international donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, or USAID for mainstream health products, as it is classified as an upper-middle-income country and largely self-funds its healthcare system. However, select public health programs in areas such as HIV, tuberculosis, and maternal and child health have historically received international support, and Global Fund grants have operated in China, though at reduced scale. The government actively promotes domestic manufacturing through policies such as the 'Made in China 2025' initiative, preferential inclusion of domestically produced devices in government procurement catalogs, and the innovative medical device special approval pathway, creating meaningful market access advantages for locally manufactured or locally partnered products.