China becomes a New Regulatory Member of ICH!


China Food and Drug Administration (CFDA) was accepted as a regulatory member in the International Council for Harmonisation (ICH) whose mission “is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.” According to the ICH, some benefits to membership include:

  • High standards for public health
  • International harmonization
  • Improved communication and relationship building in the clinical research community

In order to maintain membership with ICH, members must meet certain standards, including

  • Regulatory requirements for manufacture of pharmaceuticals
  • Conduct of clinical trials
  • Stability of pharmaceutical products

The head of CFDA Minister Bi Jingquan stated that CFDA has reformed China’s regulations to follow global ICH regulations. Future clinical trials in China will meet the global ICH standards for manufacturing pharmaceutical products and conducting clinical trials.

Because the guidelines for conducting clinical trials are harmonized across different countries who are members of the ICH, the development of new pharmaceutical products should become more efficient, better promote new products making it to market more rapidly, and most importantly, more consistently promoting the quality of clinical trials globally. Not only should China benefit from their new membership in ICH, but the rest of the members in ICH should benefit from the studies that China conducts

-The Clinical Pathways Team and Jennifer Lawyer