On January 7, 2026, China’s National Medical Products Administration (“NMPA”) released an Announcement on Further Optimizing the Review and Approval of Drugs Marketed Overseas That Are Urgently Needed in Clinical Practice (“Announcement”).[1]  NMPA published the draft announcement for comment in June 2024.[2]  The Announcement is part of series of measures that NMPA has put in place to encourage pharmaceutical innovation in China.[3]  The Announcement is significant in that it applies policies that are often reserved for drugs or indications that have not been approved anywhere in the world to those that are already marketed overseas.

The Announcement does not define the term “urgently needed” or limit the scope of drugs that can obtain the benefit of these policies.  While similar policies have limited eligibility to drugs that are on lists complied by the Center for Drug Evaluation (“CDE”),[4] with this Announcement NMPA has chosen not to compile lists of such drugs, because a static list would not accommodate changing clinical needs.[5]  Instead, any applicant with a drug marketed overseas may apply for such status and make a case for the urgent clinical demand of their product in China.  CDE will designate drugs as urgently needed in clinical practice based on expert review.

The Announcement offers the following key benefits:

  • Applications for urgently needed drugs could be included under NMPA’s priority review pathway, if unspecified “eligibility criteria are met.”  This pathway significantly reduces the technical review time for an application.
  • Applicants are encouraged to communicate with CDE prior to and during application.  If the applicant and CDE reach alignment that a clinical trial in China is needed, CDE will determine within 30 days (NMPA has recently reduced the timeline for clinical trial applications for certain innovative drugs from 60 to 30 days, see our prior post here) whether the trial may proceed.  In some cases, CDE may waive the need for a clinical trial in China altogether.
  • The timeline for registration testing for orphan drugs that are marketed overseas and urgently needed in clinical practice has been shortened.  The Announcement confirms that only samples from one batch of commercial production is needed for registration testing for orphan drugs urgently needed in clinical practice, which is a reduction from the usual three required batches.  NMPA may further reduce the quantity of samples needed, if the amount produced in each batch for an orphan drug is exceedingly low.
  • The specific mechanism for pre-registration quality system verification for drugs in the priority review pathway will be based on a risk assessment by the regulator, and could be combined with post-marketing inspections or be remote inspections as opposed on on-site.  This measure should also reduce the timeline for approval.
  • NMPA also committed to maintaining the emergency import channel for drugs not yet approved in China but urgently needed in clinical practice.  Applications for these drugs are submitted by healthcare institutions in different localities in China.

All of these policies will likely require additional guidelines from NMPA or CDE to implement.  Applicants should continue to monitor for related developments.

[1] NMPA, Announcement on Further Optimizing the Review and Approval of Overseas Marketed Drugs That Are Urgently Needed in Clinical Practice (Jan. 7, 2026), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260107152912184.html.

[2] NMPA, Announcement on Further Optimizing the Review and Approval of Overseas Marketed Drugs That Are Urgently Needed in Clinical Practice (Draft for Comment) (June 25, 2024), https://www.nmpa.gov.cn/xxgk/zhqyj/zhqyjyp/20240625142147136.html?type=pc&m=.

[3] State Council, Opinions on Further Optimizing the Foreign Investment Environment and Increasing Efforts to Attract Foreign Investment (Aug. 13, 2023), https://wzs.mofcom.gov.cn/zcfb/art/2023/art_ea98a53e1e7245158ee5cd373d867877.html (committing to optimizing application procedures for marketing authorization of drugs manufactured abroad that are being transferred to domestic production).

[4] NMPA, Announcement on the Review and Approval of Overseas Marketed Drugs That Are Urgently Needed in Clinical Practice (Oct. 30, 2018), https://www.nmpa.gov.cn/zhuanti/ypqxgg/ggzhcfg/20181030171201646.html?type=pc&m=.

[5] NMPA, Policy Interpretation on Announcement on Further Optimizing the Review and Approval of Overseas Marketed Drugs That Are Urgently Needed in Clinical Practice (Jan. 7, 2026), https://www.nmpa.gov.cn/xxgk/ggtg/ypggtg/ypqtggtg/20260107152912184.html.

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For further information or inquiries relating to this post, please email APACRegBlog@cov.com.

Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.

Photo of John Balzano John Balzano

John has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA)…

John has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China and APAC, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, implementing product recalls, and supporting virtual and onsite overseas quality inspections. John also has significant experience designing strategies to handle professional consumer litigation for companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

He is the author of the book, China Food and Drug Law: Policy, Practice, and Future Directions (Springer 2024).

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Photo of Kaixin Fan Kaixin Fan

Kaixin Fan is a member of the Food, Drug, and Device Practice Group. She advises pharmaceutical, biotechnology, and medical device companies as well as trade associations in regulatory matters. She has experience in matters relating to FDA informed consent requirements, advertising and promotion…

Kaixin Fan is a member of the Food, Drug, and Device Practice Group. She advises pharmaceutical, biotechnology, and medical device companies as well as trade associations in regulatory matters. She has experience in matters relating to FDA informed consent requirements, advertising and promotion issues, and other aspects of U.S. federal and state regulation of pharmaceuticals, biologics, and medical devices. Kaixin also assists clients in navigating complex regulatory matters in China, and works closely with local counsel in other Asia-Pacific jurisdictions. She has supported life science transactions by evaluating regulatory compliance of companies and advising on commercial agreements.

Kaixin maintains an active pro bono practice, with experience in the areas of housing, reproductive rights, and gender-based violence.

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Photo of Julia Post Julia Post

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development…

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.

Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.

Prior to joining the Food, Drug, and Device practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.

Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.

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