China emerging as global reg leader

China emerging as global reg leader
by Clarivate Analytics – Cortellis Regulatory Intelligence
Life Sciences Connect

It has been made clear: China has become a major worldwide healthcare stakeholder during the last few years. The world’s second-largest market for pharmaceuticals and medical devices, and its leading manufacturer of APIs such as penicillin, has developed its regulatory infrastructure at an incredible pace to support its booming medical products market. During the 10th DIA China Annual Meeting in Beijing in late May, a strong message was communicated through the speeches: Chinese authorities are dedicated to supporting innovation as well as to improving the quality and efficiency of the nation’s reviewing process. This article will look at three developments through which China is expected to take a leadership role in the global healthcare regulatory environment.


The world’s second-largest market for pharmaceuticals and medical devices, and its leading manufacturer of APIs such as penicillin, has developed its regulatory infrastructure at an incredible pace to support its booming medical products market.”


The CNDA and the ICH

The China National Drug Administration (CNDA) became a management member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The CNDA (former CFDA) has had an outstanding path within the ICH: An ICH office has been built up in CNDA with the mission to lead the implementation of the ICH guidelines in China. The Chinese GCP issued in 2003 were inspired from ICH E6 guidelines. In 2010, the CFDA released ICH common technical document (CTD) guidelines. In June 2017, CFDA became a regulatory member of ICH. Then, the application of secondary guidelines was officially announced with a clear plan outlined (Announcement 2018/10, published on January 25, 2018):



Some modalities remain to be set, but the reactivity and progress that Chinese authorities have shown this past year are clear. These efforts seemed to have been recognized, as CNDA was elected to the ICH Management Committee in early June at the ICH conference in Kobe, Japan. CNDA is engaged in strengthening its international cooperation for policy and technical exchanges on drug and medical device supervision. This clearly indicates that China does not just want to follow the most recent and updated international regulatory trends, but has the ambition to lead and influence the global healthcare regulatory landscape.


A focus on innovation and urgent medical need

Chinese authorities intend to put effort into supporting innovation and fostering access to drugs and devices with a high medical need, while continuing to improve the quality and safety of the products released into the market. Last October, China’s State Council announced its willingness to deepen reform around drugs and devices. This announcement stated, notably, the intention to:

  • establish a more efficient review and approval process (e.g., acceptance of clinical data from abroad in certain conditions);
  • enable a fast-track approval process for medical products with an urgent clinical need as well as drugs and devices for rare diseases;
  • continue to emphasize safety and effectiveness of products that enter the Chinese market;
  • enhance protection of innovations with a patent linkage system and protection of data.

Concrete measures to continue to implement these development efforts are expected in the near future. They would be great regulatory catalysts to drive China toward the top among healthcare innovating countries.


The MAH program to be extended

A drug Marketing Authorization Holder (MAH) pilot program was implemented in 2016, which allowed research organizations and individuals in China to hold marketing authorization for drugs, while subcontracting manufacturing through a contract manufacturing organization (CMO). The pilot program has been approved for implementation by the National People’s Congress Standing Committee (NPCSC) in 10 provinces and has been applied to the field of medical devices in Shanghai. This program is intended to enhance innovation in the country, notably by allowing doctors – who are in direct contact with patients and, thus, acutely aware of clinical needs – to drive the innovation of efficient products. This MAH program is now expected to be extended to the whole country.

It is clear that Chinese authorities envision that the country will no longer to be considered as a follower, but as a leader and influencer of the global regulatory environment. The next few months/years will demonstrate how these efforts by Chinese regulators to support innovation will propel the Chinese drug and medical devices industries forward worldwide.

Stay informed as the global regulatory landscape continues to shift and evolve. Learn more about Cortellis Regulatory Intelligence.




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