China: CFDA Solicits Comments On Drug Registration Rules

The China Food and Drug Administration ("CFDA") recently published long-awaited and comprehensive revisions ("Revisions") to the Drug Registration Rules ("DRR"). The Revisions are now open to public comments until August 26, 2016. Since the DRR is the most important regulation for seeking approval of drugs in China, the pharmaceutical industry is advised to review the Revisions carefully and offer feedback on proposed changes.

The Revisions are said to be a response to the State Council's 2015 announcement (See our Alert dated August 21, 2015) on the reform of the drug and device approval system. As a result, the Revisions contain some of the State Council's requested reforms, including simplifying the drug approval process and imposing severe penalties on false data submitted during drug registration.

Overall, key changes proposed in the Revisions can be divided into the following four categories:

1. Changes that may affect Clinical Trials

  • Remove explicit reference to international multicenter studies: Unlike the DRR, the Revisions do not distinguish an international multicenter study from a drug registration study. The China arm of an international multicenter study, if the data of which will eventually be used for applying the marketing approval in China, must be approved by the CFDA in advance. Companies can include China in any stage of the drug development process when conducting an international multicenter study, rather than having to wait until Phase 2 of the clinical study program.
  • Remove the validity term of clinical trial approval: The Revisions would remove the current DRR requirement that a clinical trial must be launched within three years from the approval date. The Revisions do, however, propose that a clinical trial approval will become invalid if the clinical hold issue can't be resolved for more than 18 months.
  • Add procedures for removing a clinical hold: The Revisions propose that, if a suspended clinical trial can resolve the clinical hold issues, the drug applicant must obtain an ethics committee ("EC") approval first, and then submit a written application regarding the removal of clinical hold to the CFDA. The Revisions also add that both the EC and the principal investigator may request to suspend or terminate an ongoing trial, if there are any unexpected serious adverse events.

2. Changes that may affect Drug Regulatory Approval Process

  • Abolish the statutory technical review time limit: Under the DRR, the Center of Drug Evaluation ("CDE") must complete the technical review within a statutory timeline. The Revisions, however, explicitly exclude the technical review timeline from the entire drug registration timeline, as well as the inspection and testing timeline. Furthermore, at the beginning of each year, the Revisions specify the CDE would need to publish a statistical report regarding the technical review, the on-site inspection and registration testing timeline of the preceding calendar year. In addition, the CDE would provide an estimate of the technical review timeline at different stages for the current year.
  • Prohibit any separate API marketing application: Under the Revisions, an active pharmaceutical ingredient ("API") marketing application would have to be bundled with a drug product marketing application. In other words, the CFDA would reject any API marketing application that is submitted separately without identifying the relevant drug product marketing application.
  • Simplify the license renewal procedure: According to the Revisions, a drug approval holder must submit the renewal application no later than three months before the drug registration approval expires. If the CFDA fails to reach a decision prior to the expiration date, the renewal application will be automatically approved.
  • Limit the scope of changes to pending applications: There is no available procedure for making changes to approved clinical trials in the current DRR. In its 2013 draft amendments (See our Alert dated November 18, 2013) to the DRR, the CFDA had proposed that an applicant for an investigational new drug approval could make changes to the approval holder, the manufacturing process, the manufacturing site and the product specification by filing a supplementary application. The Revisions, in contrast, specify that an applicant can make only non-significant changes during the clinical trial process—although the Revisions do not define "non-significant changes." In terms of reviewing the marketing approval application, the Revisions further require that any changes in the conditions of manufacturing, quality control and use must be made through a new application, rather than a supplementary application.

3. Changes that may affect the Administrative Exclusivity

  • Eliminate the linkage between patent protection and the drug approval process: In the current DRR, any applicant must submit a drug application two years prior to the expiration date of any third-party patent in China, and the CFDA cannot approve an application before the patent expires. Under the Revisions, any applicant can submit a marketing authorization application, regardless of the existence of third-party patents. This change is proposed in response to the Bolar Exemption provisions in the PRC Patent Law.
  • Limit the exclusivity scope during the new drug monitoring period: The current DRR prohibits the CFDA from accepting any applications for clinical study authorizations on a new drug during its monitoring period. However, the Revisions limit the exclusivity by only prohibiting the CFDA from accepting any marketing approval application of the same drug. In other words, the Revisions would allow the CFDA to accept and review other clinical trial authorization applications of the same drug during the monitoring period. Additionally, the Revisions would allow the CFDA to approve a third-party marketing approval application during the monitoring period, but only if the new drug has not yet been placed in the market within two years from the start of the monitoring period.
  • Grant administrative exclusivity to approved TCM new drugs: Currently, a traditional Chinese medicine ("TCM") manufacturer can apply for a TCM protection certificate separately from the drug registration procedure. If any TCM obtains a protection status designation, then only the TCM protection certificate holder can manufacture the TCM during the protection period. The Revisions propose that any TCM new drug will be granted a protection designation automatically upon the approval date of such new drug. At the same time, the CFDA will refuse to accept any marketing approval application of the same TCM. 

4. Changes that may affect the Drug Applicant's Rights and Obligations

  • Specify the qualified applicant for CADN application: Any new Chinese Approved Drug Names ("CADN") must be approved by Chinese Pharmacopoeia Commission ("CPC"). However, the Revisions specify that CDE, not the drug applicant, shall submit the CADN proposal regarding the new drug to CPC. Once CPC makes a determination regarding the new CADN, it will notify only the CDE.
  • Impose evaluation requirement for contract research or manufacturing organizations: According to the Revisions, if a drug applicant contracts a third party to provide drug development services or produce drug samples, the drug applicant must conduct an evaluation of the service provider's quality system by itself or another evaluation agency.
  • Outsource drug registration testing to private testing institutions: Currently, only the National Institute for Food and Drug Control and its provincial counterparts can conduct the drug registration tests. The Revisions allow qualified private testing institutions to handle drug registration tests.
  • Appoint a dedicated person for regulatory filings: The Revisions ask the applicants for a dedicated regulatory specialist to handle the registration applications and to communicate with the CFDA on behalf of the applicants. If the CFDA discovers any misrepresentation or falsification of data or samples in the dossiers, the responsible regulatory specialist will be blacklisted.

The Revisions unveiled many material changes to the drug registration system and will significantly impact the future business strategy of pharmaceutical companies in China. It remains unclear whether these changes will be adopted. We recommend that pharmaceutical companies closely monitor the progress of the Revisions and propose their comments by the deadline.

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.

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”

Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

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