Table 2.

Process and Mechanism of Drug Price and National Reimbursement Negotiation in China.

	Stage	Main content
1	Preparation	• NHSA draws up work plans and principles for the new round of negotiation. • NHSA solicits public opinion, and establishes working groups and expert pools.
2	Application	• NHSA release guidelines on the application of NRDL negotiation. • Pharma companies submit applications and materials required by NHSA, mainly including basic information on medicines, safety, effectiveness, economic data, and expected price. • NHSA to review applications and release public notices on applications that passed the formal review process.
3	Expert Review	• NHSA organizes experts in clinical, pharmacy, pharmacoeconomics, and medical insurance to evaluate the candidate medicines from the aspects of effectiveness, safety, economy, and innovation. Furthermore, to determine the list of medicines to enter price negotiation.
4	Negotiation	• NHSA organizes experts for pharmacoeconomics and budget impact to determine a target price for each medicine to be negotiated. • NHSA representatives negotiate with enterprises on site, to confirm the price and payment restriction. • After the negotiation, both parties shall sign the result confirmation letter on-site, regardless of whether they reach an agreement or not.
5	Results	• NHSA announces the negotiation results and updated the NRDL. • NHSA Specifies NRDL management and implementation measures.