Beijing builds rare disease drug guarantee pilot zone, expected to shorten waiting time for medication
On September 24, a new initiative was announced in Beijing to tackle the pressing needs of patients with rare diseases. The Beijing Municipal Drug Administration, alongside the Municipal Health Commission, Beijing Customs, and the Capital Airport Economic Zone Management Committee, has launched a pilot program aimed at creating a pharmaceutical support zone specifically for rare diseases. This initiative is designed to streamline operational processes and boost the supply chain for rare disease medications, ultimately aiming to minimize patient wait times while ensuring a stable supply of medications with full traceability.
Globally, there are estimated to be between 7,000 and 10,000 recognized rare diseases, with around 780,000 cases reported in China alone. The need for effective treatments is urgent. As a prominent center for quality medical resources, Beijing manages a wide range of complex patient cases that require highly tailored treatment plans and an extensive variety of medications. With new rare disease drugs being continuously developed and approved overseas, some patients have turned to unofficial channels to obtain unapproved medications in China, raising serious concerns about the safety and reliability of these options.
The new plan introduces a “white list” system to facilitate the temporary importation, circulation, and usage of urgently needed rare disease medications. By leveraging the advantages of the Tianzhu Comprehensive Bonded Zone, this model allows medicines to clear customs in one step and be utilized multiple times within the region. This shift is intended to transform the situation from “patients waiting for drugs” to “drugs waiting for patients.” In addition, the approval process for importing urgent medical supplies is being changed from a sequential evaluation to a parallel one, with guidance from the National Health Commission and evaluations conducted by a joint expert group. The plan also aims to simplify the reapplication process for importing specific drugs.
To ensure the safety and traceability of clinical medications and supplies, the Beijing Municipal Drug Administration has introduced new guidelines for developing product traceability systems within pharmaceutical import companies. This initiative is aimed at strengthening regulatory oversight throughout and after the import process, ultimately creating a comprehensive management loop.
Overall, this proactive approach underscores Beijing’s dedication to enhancing healthcare access for patients suffering from rare diseases.
