As China’s regulatory plans for drugs and medical devices for 2025 take shape, a recently released document provides a helpful blueprint for further reform from 2027 to 2035.  The “Opinions on Comprehensively Deepening the Regulatory Reform of Drugs and Medical Devices to Promote the High-Quality Development of the Pharmaceutical Industry” (hereinafter referred to as the “Opinions”) outlines 24 reform measures across five priority areas:  (1) supporting the research and development (R&D) and innovation, (2) enhancing the quality and efficiency of drug and medical device registration review and approval processes, (3) improving regulatory compliance standards for medical products, and (4) promoting greater openness and international collaboration in the pharmaceutical industry.  All of these areas are ones that China has previously endorsed (and stepped back from) at times in the past.  The Opinions may show renewed commitment going forward.

The Opinions propose several measures to bolster innovation, notably:

  • For drugs and devices that China determines to be innovative and that achieve a significant scientific breakthrough or meet an urgent clinical need, regulatory authorities would provide additional support prior to and throughout the research and development process and into marketing approval.   This increase in agency consultation resources for the applicant appears to be similar to the type of support that is provided through other expedited pathways in China, such as the Innovative Medical Device pathway.
  • Regarding intellectual property protection, the Opinions state that China would provide data protection and marketing exclusivity for innovative drugs and devices, noting that Article 34 of the current Regulations on the Implementation of the Drug Administration Law protects original and undisclosed research data submitted by drug applicants for products containing new chemical entities.  The Opinions propose to expand the scope of data protection, but do not go into detail about the applicability and length of the protection period(s).  The Opinions also propose to grant marketing exclusivity to drugs for rare diseases, pediatric drugs, first small molecule generics, and varieties of traditional Chinese medicine exclusive to the applicant.  The amendment to the Drug Administration Law Implementing Rules from 2022 that contained similar proposals has not been finalized, and China has not yet released drafts of other implementing rules related to these goals.

Regarding the goal of enhancing the efficiency of the drug and device registration process, the Opinions propose the following policies related to drugs and devices that are in urgent clinical demand or highly innovative:

  • The Opinions propose to expand the scope of existing priority review and approval pathways and further reduce the processing time.  Drugs eligible for this priority review may include urgently needed cell and gene therapies, drugs that are marketed overseas, certain vaccines, radiopharmaceuticals, and some rare and endangered medicinal herb substitutes.  On the device side, this category may include advanced medical equipment such as medical robots and imaging devices.  The timeframe for the priority review pathway would be reduced from 60 to 30 business days.
  • The review and approval process for supplements to drug registrations, e.g., for manufacturing or labeling changes, would be streamlined.  Pilot reforms in some regions have already decreased the review time for supplementary applications requiring verification and inspection from 200 working days to 60 working days.
  • The Opinions propose to simplify registration testing of drugs and medical devices by reducing the number of tests required for each batch from three to two.  A green channel for priority testing of innovative drugs and devices would be established, allowing for expedited testing for that are in urgent clinical demand.
  • The Opinions propose to exempt innovative drugs and devices for rare diseases from clinical trials in China altogether, reduce the registration test batches for drug products from three to one, and decrease the required quantity of each batch by about a one-third.  Although additional detail is not offered, these reforms would allow applicants to rely on foreign data (if possible) and to avoid what typically can be lengthy testing delays during the marketing authorization process.
  • Special importation of unapproved drugs and devices that treat rare diseases and are in urgent clinical demand by designated medical institutions would be explored.  China has permitted unapproved drugs and devices to be imported into medical tourism zones and more recently individual hospitals.

To promote the pharmaceutical industry’s openness to the global market, the Opinions propose the following types of measures:

  • Importation of commercial-scale batches of products manufactured before obtaining market approval would be allowed, provided that these products meet corresponding regulatory requirements.  Requiring products to be produced after the date of registration approval can create delays in supplying the market.
  • The process for transferring pharmaceutical and medical devices produced overseas that have been marketed in China to domestic production would be streamlined.  The Opinions also propose to support foreign-invested enterprises in producing originator drugs and high-end medical equipment locally.
  • The Opinions propose to explore a segmented production model for biological products. Provincial drug regulatory authorities could submit applications to the NMPA to pilot segmented production processes for biologics, focusing on antibody-drug conjugates and multivalent vaccines.  Qualified overseas drug marketing authorization holders would be encouraged to engage in cross-border segmented production under a unified drug quality management system.  Whereas Chinas has required most manufacturing (except some repackaging) to take place outside of China for a product to be considered imported (and vice-versa for domestic products), recent pilots have begun to permit some contract manufacturing of products by overseas marketing authorization holders to facilities in China.

The full text of the Opinions is available here: https://www.gov.cn/zhengce/content/202501/content_6996115.htm

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 Muyun Hu Muyun Hu

Muyun Hu advises multinational and Chinese companies on a range of regulatory, policy, transactional, and litigation matters. Her work focuses on the life science industry, particularly with regard to food, drug, medical device, cosmetic, and other regulated products.

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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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