I. What is the background for the issuance of this policy?

Since the implementation of the drug review and approval system reform in 2015, the National Medical Products Administration (NMPA) has continuously optimized the review and approval processes, taking multiple measures to promote the simultaneous research and marketing of overseas new drugs. In July 2020, the Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Trial) was released and implemented, improving the priority review and approval system for drugs. It explicitly stipulated that six categories of drugs, including innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases, could be included in the scope of priority review and approval.

In 2018, NMPA and the National Health Commission jointly issued the Announcement on Issues Pertaining to the Review and Approval of Overseas New Drugs Catering to Clinical Urgent Need (No. 79, 2018), clearly including overseas-marketed drugs in clinical urgent need into the scope of priority review and approval. After the release of Announcement No. 79, three lists of overseas new drugs in clinical urgent need were published, comprising 81 products in total. To date, 55 products have been approved for marketing through the priority review and approval process, effectively promoting the introduction of overseas-marketed drugs in clinical urgent need and playing a positive role in meeting clinical medication needs.

In recent years, with the continuous deepening of reforms and the increasing needs for medication among the public, there have been calls from the industry to further expand the scope of the current priority review and approval process, enabling more good overseas-marketed drugs to be quickly introduced to China. For example, clinically urgent drugs for the treatment of chronic diseases, elderly diseases, etc., which are marketed overseas but not yet available in China, may also be included in the scope of priority review and approval.

In order to further encourage more overseas-marketed drugs in clinical urgent need to enter the Chinese market and benefit domestic patients, NMPA has researched and drafted the Announcement of NMPA on Matters Concerning Further Optimizing Review and Approval of Overseas-marketed Drugs in Clinical Urgent Need (hereinafter referred to as the Announcement). This Announcement takes comprehensive measures such as expanding the scope of priority review and approval, fully utilizing domestic and international clinical research data, optimizing testing processes, and improving registration inspections to promote the entry of more overseas-marketed drugs into China in clinical urgent need.

II. What is the relationship between this Announcement and Announcement No. 79?

Announcement No. 79 played a positive role in rapidly introducing overseas-marketed drugs in clinical urgent need. Its procedures have been incorporated and encompassed into the 2020 Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Trial). The three batches of product lists selected by No. 79 remain valid, and applicants can continue to apply for the products on these lists, which can still be included in the current priority review and approval scope. For products not included in the three product lists, starting from the issuance of this Announcement, applicants may submit applications, and those meeting the requirements may be included in the priority review and approval scope. Therefore, this Announcement and Announcement No. 79 are complementary and do not conflict.

III. Will a catalog of overseas-marketed products in clinical urgent need be released?

The method of publishing a catalog of products is difficult to adapt to the rapid changes in drug research and development, innovation, and clinical needs. Therefore, this Announcement adopts a flexible working mechanism. Through enterprise applications, review by the Center for Drug Evaluation (CDE) of NMPA, and necessary expert evaluations, it adapts to the constantly changing clinical demands.

IV. Do generic drugs need to conduct clinical trials?

For overseas-marketed generic drug products, there are differences in whether clinical trials have been conducted when they were marketed overseas. Applications submitted in accordance with this Announcement that, after evaluation, meet the requirements may be exempted from clinical trials.

V. How will the testing of overseas-marketed drugs in clinical urgent need be optimized?

In July 2025, the National Institutes for Food and Drug Control (NIFDC) issued the Drug Registration Inspection Work Procedures and Technical Requirements Specification (2025 Revised Edition), introducing several measures to facilitate enterprises, such as reducing the required test quantity per batch of drug registration testing from 3 times to 2 times, and allowing applicants to use the reserved samples from the initial test for registration testing in response to supplementation during review. For overseas-marketed drugs in clinical urgent need included in the priority review and approval scope, testing institutions shall implement a priority testing process, shortening the testing timeline by 10 working days.

For overseas-marketed rare disease drugs with a short shelf life, extremely low batch production, and clinical urgency, import testing institutions will optimize the import testing strategy. Based on the product's full self-inspection report, only key quality control items and indicators that may be affected during storage and transportation will be tested, and full-item testing will not be conducted. The specific quantity and testing items will be jointly determined by the NIFDC or the port inspection institution and the applicant.

VI. What specific measures are included to optimize the temporary import channels?

To optimize the temporary import pathway for rare diseases and further accelerate efficiency, NMPA, in collaboration with the National Health Commission, will optimize relevant procedures in the pilot work zone for rare disease drug guarantees in Beijing. The city has already issued relevant implementation measures. By adopting measures such as changing the expert evaluation process from serial to parallel and allowing multiple uses of the same customs clearance, the clinical urgent medication needs of rare disease patients can be met more quickly.