Beijing Implements New Policies to Facilitate Import of Orphan Drugs and Clinically Urgent Medical Products

September 20,Six Departments, Including the Beijing Municipal Medical Products Administration, Release the "Implementation Plan for Promoting the Construction of a Pilot Zone for Rare Disease Drug Security in Beijing (Trial)"(hereinafter referred to as the “Implementation Plan for Rare Disease Drug Assurance”). The Implementation Plan for Rare Disease Drugs establishes a “white list” system in the pilot zone and optimizes the import procedure of “one-time customs clearance for multiple exits and uses,” thereby enabling one-time customs clearance and repeated use of rare disease drugs, and facilitating the transition from “patients waiting for drugs” to “drugs awaiting patients.”

On the same day,Four Departments, Including the Beijing Municipal Medical Products Administration, Issue the "Implementation Plan for Promoting Temporary Import of Clinically Urgent Drugs and Medical Devices in Beijing (Trial)"(hereinafter referred to as the “Implementation Plan for Temporary Import of Clinically Urgent Drugs and Medical Devices”). The Implementation Plan will streamline the assessment for non-first-time imports and optimize the approval workflow for the temporary import of clinically urgent drugs and medical devices, thereby supporting the establishment in Beijing of a green channel for approving such imports. This initiative aims to facilitate the temporary import of clinically urgent drugs and medical devices (hereinafter referred to as “drugs and medical devices”) into Beijing, better serving clinical needs.

To help the public understand the policies at the earliest opportunity, the Information Office of the Beijing Municipal People’s Government held a press conference at 3:00 p.m. on September 20 to update on the progress of tasks in the pharmaceutical and health sectors under the “Two Zones” initiative. Key officials from the Municipal Medical Products Administration, the Municipal Science and Technology Commission, the Zhongguancun Administrative Committee, the Municipal Health Commission, Beijing Customs, and the Shunyi District People’s Government provided policy interpretations via live online broadcast.

Rare diseases refer to conditions with extremely low incidence rates, encompassing a wide variety of disorders. Currently, there are more than 7,000 recognized rare diseases worldwide, yet only approximately 5% have available treatments. Moreover, over half of these therapeutic drugs have not been launched in the Chinese market. In the past, the treatment of rare diseases in China faced the dilemma of “drugs being available abroad but inaccessible domestically,” leaving many patients with rare diseases in a state of inadequate medical care and drug shortages.

In recent years, the Chinese government has attached great importance to patients with rare diseases, making concerted efforts to strengthen research on rare diseases and ensure access to medications. To further enhance the capacity for drug supply assurance and meet the public’s urgent clinical needs for specific medications, the National Medical Products Administration (NMPA) and the National Health Commission jointly issued the Work Plan for Temporary Import of Clinically Urgent Drugs and the Work Plan for Temporary Import of Clobazam in June 2022. On November 23, 2023, the State Council issued the Reply of the State Council on the Work Plan for Supporting Beijing in Deepening the Construction of the Comprehensive Demonstration Zone for Expanded Opening-up of the Service Sector, proposing to “support the establishment of a pilot zone for rare disease drug assurance in the Beijing Tianzhu Comprehensive Bonded Zone, explore the importation of rare disease drugs not yet registered and marketed in China, and have designated medical institutions guide the use of such drugs.”

At this point,Beijing Tianzhu Pilot Zone Becomes China’s Third Region for Special Access to Overseas New Drugs for Rare Diseases, Following Hainan Boao Pilot Zone and the Guangdong-Hong Kong-Macao Greater Bay Area

To support the Beijing Tianzhu Pilot Zone, we aim to explore a “Beijing Model” for rare disease drug coverage characterized by multi-party collaboration, efficiency and convenience, closed-loop management, and full-process traceability, thereby better meeting the clinical medication needs of patients with rare diseases. Meanwhile, we seek to establish a green channel for the import approval of clinically urgent drugs and medical devices that reflects Beijing’s distinctive features and aligns with the capital’s functional positioning, so as to better serve the clinical demand for urgently needed drugs and medical devices.

The Beijing Municipal Medical Products Administration took the lead in formulating the Implementation Plan for Advancing the Construction of a Pilot Zone for Rare Disease Drug Assurance (Beijing) (Trial) (Draft for Comments) and the Implementation Plan for Facilitating the Temporary Import of Clinically Urgent Drugs and Medical Devices (Beijing) (Trial) (Draft for Comments), and solicited public comments from August 7, 2024, to August 13, 2024.

Today, the Beijing Municipal Medical Products Administration officially released the Implementation Plan for Promoting the Construction of a Pilot Zone for Rare Disease Drug Security (Trial) and the Implementation Plan for Facilitating the Temporary Import of Clinically Urgent Drugs and Medical Devices (Trial), and has begun to promote the implementation of these policies.

Regarding the guarantee of orphan drugs, the Implementation Plan for Orphan Drug Guarantee proposes the establishment of a “white list” system in the pilot zone, primarily comprising three white lists: medical institutions, clinically urgent orphan drugs, and drug import enterprises. The “white list” covers the entire process of importation, distribution, and utilization for the supply guarantee of orphan drugs. Meanwhile, by leveraging information technology, it ensures that the sources of clinically urgent orphan drugs are traceable and their distribution pathways are monitorable.

The "White List" of medical institutions is selected and certified by the Beijing Municipal Health Commission. Medical institutions included in the "White List" may, during the pilot period, conduct comprehensive assessments based on clinical diagnosis and treatment conditions, estimate import volumes, and directly apply to the National Medical Products Administration for the import and use of clinically urgent drugs for rare diseases.

The "White List" of Clinically Urgent Drugs for Rare Diseases is established based on temporary import applications submitted to the National Medical Products Administration (NMPA) by medical institutions included in the list, according to their clinical needs. The Beijing Municipal Medical Products Administration compiles and publishes this list in conjunction with the NMPA's approvals for the import of such drugs. During the pilot period, drugs included in the "White List" may be stored as bonded inventory in the Beijing Tianzhu Comprehensive Bonded Zone. They can obtain Drug Customs Clearance Certificates in batches, allowing for multiple partial write-offs and releases from the zone under a single certificate at the Beijing Tianzhu Port, for use in the approved medical institutions.

The "White List" of pharmaceutical import enterprises is organized, selected, and certified by the Administrative Committee of the Capital Airport Economic Zone. Pharmaceutical import enterprises included in the "White List" are permitted to conduct storage, importation, distribution, and other operations for varieties on the "White List" of clinically urgent drugs for rare diseases under the bonded inventory model.

The "Implementation Plan for the Supply Guarantee of Drugs for Rare Diseases" also optimizes the import procedure of "one-time customs clearance for multiple exits and uses." Medical institutions may, on their own or by entrusting enterprises on the "white list" for drug imports, apply in batches for the "Import Drug Customs Clearance Form" based on the approval issued by the National Medical Products Administration (NMPA). There are no restrictions on the quantity of drugs imported per shipment or on the number of importations, provided that the cumulative total does not exceed the approved aggregate quantity. Customs clearance for clinically urgent drugs for rare diseases is exempt from port-of-entry inspection.

This means that the process for accessing medications will be significantly streamlined, allowing patients with rare diseases in the Beijing Tianzhu Pilot Zone to benefit from a “single application, multiple uses” model, thereby greatly enhancing the continuity of their medication regimens.

The "Implementation Plan for the Guarantee of Rare Disease Drugs" also states that Beijing Customs shall fulfill its customs supervision responsibilities for rare disease drugs in urgent clinical need stored under bond, and implement facilitation measures for customs clearance.

At the press conference, Wang Qing, Deputy Director of the Administrative Committee of the Beijing Capital International Airport Airport Economic Zone, stated, “We have facilitated the establishment of a green channel for the inspection of imported biological products, achieving an integrated service model that includes local acceptance of import drug inspections, synchronized sampling and labeling, and direct delivery of samples for testing. The clearance time for sampling and acceptance in drug inspection has been reduced from 24 hours to 1.5 hours.”

Regarding the temporary import of urgently needed clinical drugs and medical devices, the *Implementation Plan for the Temporary Import of Urgently Needed Clinical Drugs and Medical Devices* aims to optimize the approval workflow for such imports. It seeks to establish a Beijing-specific green channel for approval that is guided by clinical needs, led by healthcare institutions, and supported through coordinated services from relevant government departments, thereby further facilitating the temporary import of urgently needed clinical drugs and medical devices to better serve clinical demands.

To this end, the Implementation Plan for the Temporary Import of Clinically Urgent Drugs and Medical Devices proposes the establishment of a mechanism for guiding the collection of clinical needs and a joint assessment mechanism to enhance approval efficiency. Specifically, healthcare institutions within the administrative area of Beijing that meet the application criteria may, based on actual clinical circumstances, submit requests for the temporary import of clinically urgent drugs to the Beijing Municipal Health Commission (hereinafter referred to as the “Municipal Health Commission”) and requests for the temporary import of clinically urgent medical devices to the Beijing Municipal Drug Administration (hereinafter referred to as the “Municipal Drug Administration”) at any time.

Upon receipt of the application materials from medical and health institutions, the Municipal Health Commission and the Municipal Medical Products Administration, under the guidance of the National Health Commission and the National Medical Products Administration, shall form a joint expert panel to conduct a preliminary assessment. This assessment will evaluate whether the applicant institutions possess the requisite capability for use and management, whether the drugs and medical devices are urgently needed for clinical purposes, and whether the requested quantities are reasonable. A written assessment opinion shall be formulated and submitted to the National Health Commission and the National Medical Products Administration.

In terms of import procedures, the *Implementation Plan for Temporary Import of Clinically Urgent Drugs and Medical Devices* proposes to streamline the assessment for non-initial imports. For healthcare institutions reapplying for temporary import of clinically urgent drugs and medical devices, where there are changes in the applied varieties or the using healthcare institutions, the initial assessment opinion may be adopted, with assessment limited to the declared quantity only when necessary. This will further accelerate and enhance the efficiency of assessment and approval processes.

Furthermore, the "Implementation Plan for the Temporary Import of Clinically Urgent Drugs and Medical Devices" proposes that medical institutions may apply for the "Customs Clearance Certificate for Imported Drugs" in batches based on clinical needs. Such imported drugs are exempt from port-of-entry inspection. By optimizing end-to-end management, the facilitation of drug import customs clearance is enhanced across multiple dimensions.

The “Implementation Plan for the Supply Guarantee of Orphan Drugs” and the “Implementation Plan for the Temporary Import of Clinically Urgent Drugs and Medical Devices” shall both take effect on the date of issuance, with a trial period of two years. Currently, relevant departments—including the Municipal Medical Products Administration, the Municipal Science and Technology Commission, the Zhongguancun Administrative Committee, the Municipal Health Commission, and Beijing Customs—are advancing the implementation of related work in accordance with the conditions and procedures stipulated in the plans.

At the press conference, Wang Qing, Deputy Director of the Administrative Committee of the Capital Airport Economic Zone in Beijing, stated, “The Capital Airport Economic Zone is accelerating efforts to solicit and screen enterprises for inclusion on the white list for imported pharmaceuticals. As a next step, we will collaborate with relevant departments to release the first batch of companies on the white list for imported pharmaceuticals as soon as possible.”

Currently, the Hainan Boao Lecheng International Medical Tourism Pilot Zone, the Guangdong-Hong Kong-Macao Greater Bay Area, and the Beijing Tianzhu Comprehensive Bonded Zone are actively exploring and refining mechanisms to facilitate the import of drugs for rare diseases and clinically urgent medical devices and pharmaceuticals. These efforts aim to further address the disparity where treatments are available abroad but not domestically, thereby continuously improving the accessibility of medical products. In the future, as policies are further refined and effectively implemented, the therapeutic landscape for patients in China will continue to improve, fostering greater development and innovation in the nation’s healthcare sector.