China: China FDA Announces Implementation Scheme To Improve The Drug Approval System

Last Updated: 19 November 2015
Article by Katherine Wang

Following the reform of the drug and device approval system by China's State Council in August,1 the China Food and Drug Administration ("CFDA") has finally unveiled its implementation policies regarding improvements to the drug approval system, with the November 11, 2015 release of the Circular Concerning Several Policies on Drug Registration Review and Approval (CFDA Circular [2015] No. 230, the "No. 230 Circular") and several draft implementation measures. These documents set the stage for the transformation of China's drug approval system and include the following changes:

  • Piloting the Marketing Authorization Holder ("MAH") system
    The current legal framework only permits drug manufacturers to obtain regulatory approvals and was perceived as an obstacle to innovation. R&D-based companies must commit to a substantial investment in manufacturing facilities in order to commercialize their assets. To create a more supportive regulatory framework for innovation, the Standing Committee of the National People's Congress authorized the State Council to roll out a three-year pilot program of the MAH system in 10 provinces,2 effective as of December 1, 2015. Under the CFDA's proposed MAH pilot program, domestic drug manufacturers, domestic R&D institutions and research personnel of Chinese nationality can obtain regulatory approvals to commercialize pharmaceuticals in principle,3 and completely outsource the actual manufacture to contract manufacturing organizations. Nevertheless, the MAH applicants must arrange for insurance or financial guarantee to cover product liabilities. 
  • Expanding the fast track approval pathway
    To date, the fast track approval pathway has been mainly available for drugs that have not been marketed anywhere in the world, or those addressing critical or unmet medical needs. The State Council has directed the CFDA to admit more types of drugs to the fast track approval pathway, including pediatric/geriatric drugs, drugs treating China-prevalent diseases, drugs sponsored by national science and technology grants, foreign innovative drugs to be manufactured locally in China, innovative drugs using advanced technology, using innovative treatment methods, or having distinctive clinical benefits, drugs manufactured at a US/EU qualified facility and under review by the USFDA/EMEA for concurrent marketing authorizations. The clinical trial applications and marketing authorizations for drugs addressing urgent clinical needs will also be accelerated. Under this condition, clinical trial applications submitted three years prior to the date of patent expiration or marketing authorization applications submitted one year prior to the date of patent expiration, will be permitted.
  • Changing the classifications for new drugs and generics
    According to the State Council's directive, new drugs refer to those pharmaceutical products that have never been marketed anywhere in the world, or those that represent improved forms of the new drugs. Generics refer to those pharmaceutical products that are consistent with the reference drugs (or originator drugs) quality and efficacy. These definitions are very different from the current definitions under the CFDA's Drug Registration Rules. The CFDA plans to introduce a new classification system that adopts the State Council's definitions and will classify pharmaceutical products that have been marketed outside China but not in China as generics. 
  • Simplifying the approval process for clinical trials
    The CFDA will adopt a one-time umbrella approval procedure, rather than a phase-by-phase approval, for any new drugs' clinical trial application. Furthermore, beginning December 1, 2015, the bioequivalent study of generic drugs will only need to undergo a recordation filing with the CFDA. In the CFDA proposed regulatory framework for the recordation filing, the applicant must obtain an EC approval and sign a clinical study agreement with the clinical site prior to filing the bioequivalent study. The CFDA will designate an information platform to record the bioequivalent study. This platform will generate a filing number once the applicant has submitted the required materials; the applicant can launch the bioequivalent study only after obtaining the filing number. If there is any change to the originally recorded bioequivalent study, the applicant must suspend the original study, enter the changes in the online recordation platform to obtain a new filing number, and only re-launch the study thereafter. 

These initiatives illustrate the Chinese government's clear determination to stimulate innovation and reduce time to market for new drugs. Pharmaceutical companies should adapt their business model to the new regulatory landscape, for example, by exploring early-phase concurrent drug development opportunities for innovative drugs in and outside China, refining the product portfolio to reflect disease demographics and public health priorities in China, revisiting the marketing authorization holder designation for innovative drugs, and leveraging regulatory flexibilities to acquire or spin off assets. Furthermore, foreign pharmaceutical manufacturers should look into the feasibility of localizing the research, development and/or manufacturing of their innovative assets in China, as the degree of localization may also affect time-to-market under the new drug approval system. 

1 See our alert dated August 21, 2015.
2 Beijing City, Tianjin City, Hebei Province, Shanghai City, Jiangsu Province, Zhejiang Province, Fujian Province, Shandong Province, Guangdong Province, and Sichuan Province.
3 Narcotic, psychopathic, toxic, radioactive, a biological prophylactic, or blood products will be excluded from this pilot program.

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”

Mondaq Advice Centre (MACs)
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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.


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.