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# China Joins ICH Drug Harmonization
- URL: https://www.fdaweb.com/china-joins-ich-drug-harmonization/
- Published: 2017-08-09T12:00:00.000Z
- Updated: 2026-09-14T22:40:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139343

CDER Office of Strategic Programs director **Theresa Mullin** says she was in China recently when that country’s Food and Drug Administration submitted its membership application to the International Council for Harmonization (ICH). That action is important, she writes in an *FDA Voice* blog [post](https://blogs.fda.gov/fdavoice/index.php/2017/08/china-joins-ich-in-pursuit-of-global-harmonization-of-drug-development-standards/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), because drug development is increasingly a global endeavor that 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.

Mullin writes that the ICH requires that new members 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.

During the trip, she says, discussions with Chinese FDA officials revealed that that agency faces many of the challenges faced by the U.S. FDA and other ICH regulators. “China needs to ensure that patients have access to innovative products, and that pharmaceuticals are safe and are held to a consistent quality standard,” she says. “\[CFDA head\] Minister **Bi** **Jingquan** 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.”