The National Healthcare Security Administration (NHSA) has issued the “Guidelines for Risk Management of In-Shortage Drug Prices,” which call for all localities to temporarily suspend the acceptance of applications for direct online listing of in-shortage drugs before January 1, 2025.
Suspension of Direct Online Listing and Price Increase Requests
The guidelines address the price increase requests related to in-shortage drugs, including those that are prone to shortages with a manufacturer distribution rate lower than 10% for three consecutive months within the same variety in a certain province. For ex-listed drugs with emergency handling requests by the leading department of the linkage mechanism and drugs with their Marketing Authorization Holders (MAHs) leveraging online listing channels in the name of shortage, direct online listing or direct adjusted listing prices can be filed in the provincial pharmaceutical centralized procurement institutions.
Procedures for First Price Increases and Risk Prevention
Provinces witnessing the first price increases are to handle direct listing or direct adjusted listing prices through straight-through processes, filling vacancies in the proper order or conditional approaches. New products from in-shortage drugs and prone-for-shortage drugs that are approved for marketing, as well as drugs first filed for online listing in the pharmaceutical centralized procurement institution, are considered first price increases. Additionally, the newly added dosage form specifications of products already listed online with prices higher than the calculation results of the drug price difference comparison are also deemed as first price increases. The first provincial pharmaceutical centralized procurement institution to accept such filings for review is advised to implement measures to prevent price risks.-Fineline Info & Tech
