To accelerate the introduction of effective and innovative drugs from overseas and fill unmet clinical needs of domestic patients, in addition to new drugs for major and rare diseases, urgently needed drugs already marketed overseas for the treatment of chronic and geriatric diseases can now be included in the priority review and approval scope of the National Medical Products Administration (NMPA). Furthermore, for eligible generic drugs already marketed overseas, clinical trials may be waived, allowing pharmaceutical companies to directly submit applications for marketing authorization.

On January 7, the National Medical Products Administration (NMPA) issued the "Announcement on Further Optimizing the Review and Approval of Clinically Urgent Drugs Already Marketed Overseas" (hereinafter referred to as the "Announcement"). The Announcement reiterated the principle of "adhering to clinical value as the guiding principle and encouraging applicants to conduct simultaneous global research and development and apply for market approval in China," while clarifying that "original drugs and generic drugs already marketed overseas that are clinically urgent are encouraged to apply for approval in China, and those that meet the requirements can be included in the priority review and approval scope."

More than seven years ago, the National Medical Products Administration and the National Health Commission jointly issued the "Announcement on Matters Related to the Review and Approval of Clinically Urgent Overseas New Drugs" (No. 79 of 2018) (hereinafter referred to as "Announcement No. 79") in 2018, which proposed to "include clinically urgent overseas marketed new drugs in the scope of priority review and approval." However, at that time, the scope of drugs that could be included in the special channel for review and approval mainly consisted of three types of new drugs that were "marketed in the United States, the European Union, or Japan in the past ten years but not in my country." Specifically, these included drugs for the treatment of rare diseases, drugs for the prevention and treatment of serious life-threatening diseases for which there are no effective treatments or preventive measures, and drugs for the prevention and treatment of serious life-threatening diseases for which there are obvious clinical advantages.

Following the issuance of Announcement No. 79, the National Medical Products Administration (NMPA) has released three batches of lists of urgently needed overseas new drugs, covering a total of 81 varieties. According to the latest statistics from the NMPA, 55 of these varieties have already been approved for marketing in China through the priority review and approval process.

"In recent years, with the deepening of reforms and the increasing demand for medicines from the public, the industry has called for further expanding the scope of the current priority review and approval process, so that more effective drugs already marketed overseas can be quickly introduced into China," the National Medical Products Administration (NMPA) stated in its announcement interpretation document. Against this backdrop, the NMPA cited examples such as urgently needed drugs for treating chronic diseases and geriatric conditions that are already marketed overseas but not yet in China, which could also be included in the priority review and approval scope.

This announcement further expands the scope of priority review and approval for drugs already marketed overseas to include "original drugs and generic drugs." The National Medical Products Administration also stated that it will not limit the scope of priority review and approval by "publishing a list of urgently needed overseas marketed drugs."

"The current method of publishing a list of drug varieties 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, which involves enterprise applications, review by the Center for Drug Evaluation of the National Medical Products Administration, and necessary expert assessments to adapt to the ever-changing clinical needs," the National Medical Products Administration stated.

To expedite the review process, the announcement also states that research data from overseas drug registration and marketing (including all clinical data and necessary pharmaceutical, non-clinical, and other research data), post-marketing clinical application and safety monitoring reports, benefit-risk assessment analyses for cross-ethnic/regional applications, and post-marketing risk control plans (including post-marketing clinical research plans) can all support domestic drug marketing applicants in applying for Category I communication and exchange, in conjunction with priority review and approval procedures and conditional applications. Furthermore, applicants are encouraged to submit data from international multicenter drug clinical trials conducted in China.

Among these, there are differences regarding whether clinical trials were conducted for generic drugs already marketed overseas. The National Medical Products Administration (NMPA) has clarified that "applications submitted according to this announcement, which meet the requirements after evaluation, may be exempt from clinical trials." This exemption means that applicants can directly submit their drug marketing authorization applications.

The issue of rare disease patients having access to medications abroad but not in China is also a key focus of this announcement.

According to Article 6 of the "Instructions for Import Inspection and Submission," "Under normal circumstances, the sample quantity should be three times the amount used for one inspection," and batch-by-batch inspection should be implemented. Research shows that due to the extremely small number of patients with rare disease drugs, the import volume is low and the prices are expensive. The sampling rate for some rare disease drugs reaches 42%, or even exceeds 50%, placing a significant economic burden on enterprises.

In July 2025, the China National Institutes for Food and Drug Control released the "Procedures and Technical Requirements for Drug Registration Inspection (2025 Revised Edition)," which proposed measures to facilitate enterprises, such as reducing the inspection volume of each batch of drug registration inspection from 3 times to 2 times, and allowing applicants to use the retained samples from the first inspection for registration inspections requested during the review process.

This announcement further clarifies and improves the testing system to reflect the characteristics of different drug varieties. For rare disease drugs that are urgently needed clinically but are marketed overseas but not domestically, the sample quantity required for registration testing is one batch of commercially produced drugs, and the sample quantity for each batch is twice the quantity required for the quality standard testing items. For rare disease drugs with extremely low single-batch production, the applicant may work with the testing institution to determine the minimum sample quantity required for the registration testing items.

In addition, the announcement also stated that the temporary import channels for urgently needed clinical drugs will be kept open. The temporary import pathway for rare diseases will be optimized to further accelerate and improve efficiency, meeting the urgent clinical needs of medical institutions for rare disease drugs.

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