China

The National Medical Products Administration (NMPA), formerly known as the China Food and Drug Administration (CFDA), is the primary authority responsible for the regulation 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 a suite of NMPA-issued technical guidelines. The general approval process involves preclinical and clinical evaluation, dossier submission to the NMPA (or its provincial counterparts for lower-risk products), technical review by the Center for Drug Evaluation (CDE) for pharmaceuticals or the Center for Medical Device Evaluation (CMDE) for devices, and final administrative approval. Products are classified by risk level, with higher-risk Class III medical devices and novel pharmaceuticals subject to the most rigorous national-level review.

China requires a China-based legal agent or representative for all foreign applicants, and local clinical data have historically been mandatory, though significant reforms have relaxed this requirement for priority and innovative products. Dossiers generally follow the Common Technical Document (CTD) format for pharmaceuticals, adapted to NMPA requirements, while medical device submissions follow NMPA-specific technical file standards aligned in part with IMDRF frameworks. Key recent reforms include the 2017 accession to the International Council for Harmonisation (ICH), accelerated pathways for breakthrough therapies and orphan drugs, conditional approvals, the Medical Device Registration Holder (MDRH) system introduced in 2021, and expanded acceptance of overseas multi-regional clinical trial (MRCT) data. China has also introduced a digital health regulatory framework addressing software as a medical device (SaMD), governed by guidance issued by the NMPA from 2021 onward.

Public procurement of health products in China operates through a centralized and semi-centralized structure overseen by multiple government bodies. The National Healthcare Security Administration (NHSA), established in 2018, plays a pivotal role by administering the national basic medical insurance (BMI) system and driving volume-based procurement (VBP) programs. The National Organized Drug Procurement (NODP), commonly known as the 'group purchase' or centralized procurement program, is coordinated through the Joint Procurement Office and implemented via provincial and municipal procurement platforms. Hospitals, which are the primary purchasers of health products, are required to procure through government-designated platforms, and winning products under VBP rounds benefit from significant volume guarantees in exchange for substantial price reductions. The National Development and Reform Commission (NDRC) and the Ministry of Finance also play roles in price regulation and budget allocation for public health facilities.

The private sector in China represents a substantial and growing procurement channel, encompassing private hospitals, retail pharmacy chains, and direct-to-consumer digital health platforms. Private procurement generally operates outside the VBP framework, offering more flexible pricing but requiring separate commercial distribution agreements. China does not rely significantly on international donor-funded procurement mechanisms such as UNICEF Supply Division, the Global Fund, or USAID-supported channels for most mainstream health products, given its upper-middle-income status and largely self-funded public health system. However, select public health programs addressing HIV, tuberculosis, and malaria may involve coordination with international agencies. Domestic manufacturing is strongly incentivized through government industrial policy, including the 'Made in China 2025' initiative, preferential access in public tenders for locally manufactured products, and government support for domestic innovation, creating meaningful market access advantages for locally produced health technologies over imported alternatives.