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Sea Change: China Joins ICH -- International Harmonization of Drug Rules

publication date: Jun 2, 2017
author/source: Richard Daverman, PhD

China has been accepted as a member of the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use). The ICH is a world-wide organization, originally set up by the US, Europe and Japan in 1990 to standardize global drug regulations (approvals, good manufacturing practices, etc). The news means that China intends to continue reforms that will bring China drug regulation into line with international standards. Because of the acceptance, it should become easier for drugmakers, in China and ex-China, to bring their products across borders. But how much easier and when the reforms will take effect -- those remain open questions.  

Instant China approvals for drugs from multinational pharmas are not likely to happen, any more than a Japan approval currently implies simultaneous acceptance in the US. Nevertheless, the ICH membership will push China to follow international norms, making compliance with China's acceptance and regulatory procedures less cumbersome for foreign companies. The same is true for China's innovative drug sector, which should see less skepticism from ex-China markets, and maybe even more importantly, for the country's generic drug makers, which have not made significant inroads into foreign markets.

Another area of regulatory reform is China's manufacturing of APIs. Currently, API makers must comply with two sets of Good Manufacturing Practices -- China's and those from the target country. The difference between the two sets should diminish as China implements the changes that ICH membership will entail.

China is already moving toward international standards for drug development, manufacturing and IP protection. Last month, the CFDA floated proposals that will speed regulatory response times and improve IP protection (see story). A few years ago, the latest China proposals would have been shockingly revolutionary. Now, they seem more like "pleasantly forward looking." The ICH membership shows China is serious about moving even further ahead -- remember that China wants to be a technological leader, in drugs as in other areas -- and it helps the effort to adopt global standards to compete.

Disclosure: none.

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