China

China is Emerald Clinical’s largest hub outside the head office of Singapore, offering full CRO services and a site network that spans the country.

With its large potential for patient recruitment and a rapidly growing pharmaceutical market, China – currently the second largest in the world – is an obvious choice for many when entering the Asian market.

The Chinese healthcare delivery system consists of public hospitals and community healthcare centers, with an increasingly private care system. Recent NMPA (CFDA) changes in the regulatory environment have reinforced the need for quality data to be both verifiable and transparent with an increasing acceptance of ICH GCP standards. A complete overhaul of the regulatory process in July 2018 was undertaken to encourage innovation and shorten CTA approval times to 3 months. Additionally, truly innovative molecules may also apply for expedited approval shortening CTA approval times to as little as 2 months. A similar overhaul of the registration process has also been undertaken for medical devices and IVD products. These changes are significant and make China an increasingly attractive destination for trials.

Emerald Clinical has been conducting clinical trials in China since 2007 with an extensive network of over 360 trial centers in 60 cities for Phase I‑IV trials.