In China, the market access process begins with the default requirement for obtaining marketing authorisation for a drug – conducting a clinical trial. Once completed, an application can be submitted to the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for marketing authorisation.
A new medicine can only be reimbursed when it is selected by the National Healthcare Security Administration (NHSA) to be included in the National Reimbursement Drug List (NRDL), or by the provincial level healthcare security administration to be included in the Provincial Reimbursement Drug List (NRDL). The NHSA annually updates the NRDL through a negotiation process with manufacturers.
The price of medicines on the reimbursement list is determined by negotiation of reimbursement rates. For certain types of drugs, such as narcotic drugs and psychotropic drugs, prices are set or guided by the government. For other drugs, prices may be freely set by the manufacturers and retailers, provided that they accurately reflect costs.
Despite efforts to establish a standardised health technology assessment (HTA) process in China, nothing has been published at the moment and this remains in development.
Complex sharing of responsibility
When navigating the regulatory bodies for pharmaceuticals in China, one of the challenges is understanding the complex sharing of responsibility. Although the NMPA is the primary agency for approval, others also play important roles in the regulatory framework. The NMPA is the Chinese counterpart of the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, but it belongs to the State Administration for Market Regulation (SAMR), a department of the central government that regulates market competition, monopolies, intellectual property and drug safety. The National Health Commission (NHC) is similar to the Department of Health and Social Care in the UK in some respects. It is a ministry department of the central government that oversees all aspects of the medical profession and hospitals. It plays a part in determining the National Essential Drug List which provides the basis for the formulation of the NRDL. Other organisations are responsible for pricing and reimbursement (NHSA), granting patents (China National Intellectual Property Administration) and imported medicines (China Customs Administration), creating a complex web of responsibilities.
Changing legislation environment
Chinese legislation features generality and flexibility. To execute laws there are usually many administrative rules and guidance notes issued by each administration. The primary statute regulating medicines is the Drug Administration Law (DAL), which was enacted in 1984 and substantially amended in 2001 and 2019. Under the DAL, the NMPA administers several agency rules to govern activities such as registration, manufacturing and marketing of medicines. The CDE of NMPA also issues its own rules and guidance to implement the DAL, in relation to medicine development and registration and priority pathways.
The core regulations governing clinical trials and small molecule medicine and biologic registration are the Drug Registration Regulations (DRR), for which the NMPA finalised a substantial amendment in 2020. Reform of the NMPA's rules and guidelines on various aspects of medicines continues on a regular basis.
This sharing of responsibility among government bodies creates a complex system in many respects, and the frequent changes to the legislative environment due to the ongoing healthcare reform make it challenging to gain market access in China. Successful access to the Chinese market requires an in-depth knowledge of relevant laws and regulations.
On the other hand, the ongoing reform also indicates a shift in the environment from an opaque system to a transparent and predictable direction, which may make market access in China less perplexing in the future.
For example, since 2019 companies have been allowed to make an application for their products to be included on the NRDL via an online portal, where previously they were not entitled to apply for selection at all. The update of the NRDL has moved from an irregular occurrence to a regular procedure on an annual basis. This is a promising sign that the NHSA has become more proficient at managing the NRDL, a positive indication for accelerating market access in China.
We have recently launched MAP Online China with a wealth of resources and regularly updated details to support you when navigating the complex environment in China. Please contact our Member Support team with any questions you have, including if you would like to book a navigational tour.
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