China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards

By: Theresa M. Mullin, Ph.D.

Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination.

Group photo from trip to China

FDA’s Theresa Mullin (center) and the FDA delegation engaging in a discussion on ICH and generic drugs with the faculty and students at Yeehong Business School/Shenyang Pharmaceutical University in Beijing China.

I am pleased to have been in China recently, when the China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonisation or ICH). As part of a team of FDA officials whom CFDA invited to share regulatory advancements, we discussed how modernizing regulatory review systems can promote public health.

ICH, first created in 1990 by regulatory agencies and industry associations from the United States, Europe, and Japan, was established to facilitate international collaboration, and has been successful in standardizing and elevating drug development practices throughout the world. ICH’s mission helps to increase patient access to safe, effective, and high quality pharmaceuticals, and to ensure that pharmaceuticals are developed and registered efficiently.

As globalization has evolved, the ICH has kept pace and membership criteria are robust. Among those criteria new members must implement a basic set of regulatory requirements for the manufacture of pharmaceuticals, for the conduct of clinical trials, and for stability testing of pharmaceutical products. In fulfilling these and other criteria, CFDA joins the existing ICH Assembly, which includes eight regulatory authorities and six industry associations from across the globe.

Janet Mullin and CFDA Official

CFDA Minister Bi presents FDA’s Theresa Mullin a congratulatory letter for FDA Commissioner, Scott Gottlieb, personally handwritten with Chinese Calligraphy.

During our trip, we met with the head of CFDA, Minister Bi Jingquan, and some members of his senior leadership team. Our discussions revealed that CFDA faces many of the same challenges that our other ICH partners and we do. China needs to ensure that patients have access to innovative products, and that pharmaceuticals are safe and are held to a consistent quality standard. Minister Bi emphasized that CFDA has implemented reforms to align China’s regulations with global standards to address these public health concerns. CFDA has also reformed its drug review system, dedicated additional resources to carry out its important mission, and implemented ICH Guidelines.

International harmonization of regulatory standards means that pharmaceutical manufacturers and developers will be held to the same standards in different markets, which will make the development and delivery of quality pharmaceuticals to the public more timely and efficient. CFDA’s membership in ICH marks a significant milestone in expanding ICH’s impact and promoting global public health.

Officials from CFDA will visit FDA later this year to continue our conversation on regulatory modernization. FDA congratulates CFDA on their progress towards regulatory modernization and membership in ICH. Additionally, FDA welcomes their future contribution to global regulatory harmonization.

Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research