China: China's FDA Reform Will Encourage Life Science Innovation

Last Updated: 21 November 2017
Article by Katherine Wang and Silvia Mo

The China Food and Drug Administration Office (CFDA) continues to reform the current review and approval system for drugs and devices, according to a circular entitled the Opinions Regarding Strengthening the Review and Approval System Reform to Encourage Innovation of Drugs and Medical Devices (opinions). The opinions outline a series of robust reform initiatives, and reflect the Chinese government's unprecedented determination to accelerate drug and device approvals and encourage innovation.

The opinions were finalized based on four draft reform proposals issued by the CFDA this May. Compared with the CFDA's draft proposals, the opinions introduce a few new initiatives: a pilot program to grant compensatory patent term extensions to certain new drugs, and calling the CFDA to accelerate the early launch of generic drugs, biosimilars and follow-on drug-device combination products. On the other hand, the opinions remove details of the patent linkage system, the protection period for regulatory data and the pre-IND submission consultation meetings.

The opinions will create a level playground for R&D-focused drug and device companies, at home and abroad. Launches of imported innovative drugs and devices in China have historically been much later than the first launches in the country of origin, because the conduct of clinical studies requires the CFDA's advance approval on a phase-by-phase basis, and in-country clinical study data derived from Chinese patients is typically required to prove safety and efficacy. The shortage of CFDA-qualified clinical study sites limits the infrastructure for clinical development, and increases study costs. Moreover, the CFDA typically requires NDA applicants to complete all three phases of clinical studies before filing for the NDA. The opinions propose the following key measures to address these challenges.

Deregulating the Conduct of Clinical Studies on Drugs and Devices

  • Admission of foreign study data: Foreign clinical data can be used to support the marketing applications for drugs and devices in China, as long as the data comply with Chinese regulations. For any drug and device applied for marketing approvals in China for the first time, the applicants must provide clinical data to prove if there are no ethnicity differences.
  • Clinical trial approval process: The clinical trial approval process will be streamlined greatly. Companies can conduct a study immediately after a 60-day waiting period expires, if the Center of Drug Review (CDE) or Center of Medical Device Review (CMDE) does not object to the filing or issue a deficiency notice.
  • Clinical sites management: the opinions revoke the current clinical site qualification system. Any institutions that have the necessary infrastructure may become qualified clinical sites after filing for record with the CFDA.
  • Ethics committee review process: the opinions encourage mutual recognition of ethics committee (EC) approvals through a unified EC review platform. In the event of multi-center studies, the participating sites must directly endorse the EC approval of the lead site, without repetitive reviews.
  • Expanded access to investigational products: Patients not enrolled in a clinical study may have access to investigational products, if they give informed consent and the investigational product is intended for treating life-threatening diseases with no effective treatments. The safety data generated from the expanded use can be used to support marketing authorization applications.

Accelerating the Drug and Device Approval Process

  • Expedited reviews for urgently needed therapies: If drugs and devices offer new solutions for treating life-threatening diseases or address critical unmet medical needs, they can be eligible for conditional approvals, as long as early and mid-stage study data indicate their efficacy and predict their clinical value.
  • Supportive regime for rare disease cures: The national health authorities will publish a catalogue of rare diseases and establish a rare disease patient registry. Drugs and devices approved outside China that offer new solutions for treating rare diseases will be eligible for conditional approvals.

The opinions also attempt to strike a balance between innovative drug and device manufacturers and manufacturers of follow-on products. Exclusivity entitlements for innovative products will enhance, but first-to-market follow-on products will also enjoy certain exclusivity and market access benefits. A combination of initiatives will be rolled out to promote pharmaceutical innovation and the growth of generics.

  • "China Orange Book": The CFDA will publish a "China Orange Book" listing all approved drugs in China. The listing will contain the registration category of the approved drugs and their active ingredients, dosage forms, specifications, marketing authorization holder (MAH), and other regulatory exclusivity entitlements (i.e., patents, and regulatory data protection periods).
  • Patent linkage system: Generic drug applicants must describe the status and ownership for patents that relate to the drug and must inform the originator/patentee about the generic filing within the time limit. The CDE will continue the technical review, even if there is an on-going drug patent dispute. However, the CFDA will base its marketing approval on court decisions on patent disputes. If the court fails to reach a timely decision, the CFDA can issue marketing approvals directly.
  • Compensatory patent term extensions pilot program: The authority will grant compensatory patent term extensions to certain new drugs whose launches were delayed due to the review and approval process.
  • Improved regulatory data protection system: NDA applicants can apply for regulatory data protection along with their submissions. First-to-market generics will also enjoy a certain period of regulatory data protection. The CDE will not approve marketing authorizations for the same drugs during the protection period, except if the applicants can prove that they generate their data independently or obtain an approval from the original data owner.
  • Market access benefits: Hospitals will be encouraged to use new drugs that are effective and reasonably priced. The government will support inclusion of innovative drugs in the basic medical insurance scheme, and the reimbursable drug list will be updated more frequently.

Notably, the CFDA will shift its regulatory philosophy from the focus of pre-approval administration to post-approval enforcement. MAHs are expected to ensure compliance throughout product life cycles, and they need to supervise the activities of their contracted research organizations, manufacturers and distributors. The CFDA and local FDAs will continue to ensure good clinical practice (GCP), good manufacturing practice (GMP) and good storage practice (GSP) (collectively, GxP) compliance through rigorous inspections. Medical representatives are allowed to conduct only academic promotion and technical consultation when interacting with physicians and are prohibited from engaging in drug sales. MAHs must register their medical representatives with local FDAs, and their registration will be timely published.

The CFDA will strengthen its infrastructure to effectively respond to the new regulatory paradigm. The agency plans to contract qualified third parties to conduct drug and device reviews, and it will establish an electronic common technical document (eCTD) system to standardize the format of electronic submissions of drug and device applications. Technical reviews for new drugs and devices will be led by a team of cross-disciplinary reviewers. The CFDA and local FDAs will strengthen risk-based, on-site inspections and for-cause inspections for GxP compliance through the product's life cycle, and build a professional team of inspectors through recruiting and training initiatives. Finally, the agency will step up its efforts to harmonize international technical standards and achieve mutual recognition of review and approval decisions.

The opinions will likely transform the competitive dynamics in China's life sciences industry and considerably impact multinational pharmaceutical and device companies' strategy on the Chinese market. While the opinions set forth only general principles, the CFDA will announce more detailed implementation measures and other administrative authorities. R&D-based pharmaceutical and medical device manufacturers should carefully study the opinions, monitor the follow-on implementation measures and analyze their impacts on business operations in China.

This article by partners Katherine Wang and associate Silvia Mo was published by Law360 on November 15, 2017.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
CMS Cameron McKenna Nabarro Olswang LLP
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Similar Articles
Relevancy Powered by MondaqAI
CMS Cameron McKenna Nabarro Olswang LLP
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions