China’s National Medical Products Administration (“NMPA”) recently issued the Draft Announcement on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (the “Draft Announcement”) for public comment.  The Draft Announcement proposes to accelerate clinical trial reviews by shortening the timeline for certain innovative drugs from 60 business days to 30 business days.  The Draft Announcement follows the Notice on the Issuance of the Pilot Work Program for Optimizing the Review and Approval of Innovative Drug Clinical Trials (“Pilot Work Program”) issued in July 2024 (see here for our blog post discussing the Pilot Work Program).  These changes are intended to increase the efficiency of the drug clinical trial review and approval processes. 

Key features of the Draft Announcement are as follows:

  • Application Scope: The Draft Announcement broadens the application scope of the Pilot Work Program.  It applies to all Registration Category I innovative drugs (i.e., new to the world innovative drugs), including chemical drugs, biologics, and traditional Chinese medicines.  It also extends the 30-day review nationwide, removing the prior limitation to Beijing and Shanghai under the Pilot Work Program.
  • Drug Requirements: To qualify, drugs must meet one of three conditions: (i) designation as a nationally prioritized innovative drug receiving comprehensive policy support; (ii) inclusion in the CDE’s pediatric-focused “Spark Program” (星光计划, a pilot program to support anti-tumor drug R&D for kids launched by CDE in May 2025) or “Rare Disease Care Program”; or (iii) be a globally synchronized investigational product, where the application is for a Phase I, II, or III international multi-center trial.
  • Applicant Requirements: Applicants must submit materials demonstrating thorough review on the lead trial institution’s ethics compliance and the principal investigator qualifications.  The Draft Announcement also states that the materials must demonstrate “regulatory compliance circumstances,” but does not further explain this requirement.  Importantly, applicants must collaborate with trial sites to synchronize project approval and ethics review prior to submission of the clinical trial application with NMPA.  Applicants are further required to possess risk assessment capabilities proportionate to the complexity of the drug’s R&D program and commit to initiating trials (which are considered to commence on the first subject’s signature of the informed consent form) within 12 weeks of approval.
  • Application Materials: The Draft Announcement provides that a list of required application materials for this special pathway will be separately formulated and published by the CDE.

Once finalized, the Draft Announcement will extend eligibility for 30-day reviews to all Registration Category I innovative drug applicants nationwide that meet the conditions above.  If CDE’s review of these applications cannot be completed within 30 business days due to technical reasons, such as the need to consult with experts, the review shall follow the normal application timeline of 60 business days.

Stakeholders must submit comments to NMPA by July 16, 2025.

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 Kexin Yang Kexin Yang

Kexin Yang focuses on government and internal investigations, as well as regulatory work related to food, drugs, and medical devices in China. She has experience advising multinational companies on highly sensitive investigations in China and other countries in Asia, particularly in the areas…

Kexin Yang focuses on government and internal investigations, as well as regulatory work related to food, drugs, and medical devices in China. She has experience advising multinational companies on highly sensitive investigations in China and other countries in Asia, particularly in the areas of FCPA and export controls. In the regulatory sphere, Kexin advises companies in the food, pharmaceutical, biotechnology, medical device, and cosmetics sectors, as well as trade associations, on compliance with Chinese regulations. She has also supported life sciences transactions by evaluating regulatory and compliance risks and advising on commercial agreements.

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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 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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