Flag-map_of_the_People's_Republic_of_China clinical trial dataChina announced earlier this month that it will begin accepting clinical trial data from other countries, Outsourcing-Pharma.com reports. The new guideline, issued by the General Office of the Communisty Party of China Central Committee and the General Office of the State Council, is part of China’s move to reform the country’s management of clinical trials. In an online post, the State Council explained the guideline intends to promote “the adjustment of industrial structure and technological innovation in the sector of drugs and medical devices, improving industrial competitiveness, and meeting the public’s clinical needs.”1

In the post, the State Council goes on to explain that “the management of clinical trial will be reformed through record-filing management of clinical trial institutes, encouraging social forces to invest in clinical trial institutes, and supporting medical organizations, research institutes and colleges to conduct clinical trial.”1 Importing clinical trial data from outside the country could lead to broadened eligibility of Chinese based sites to conduct clinical trials,  more standardized regulatory requirements, and shorten approval times, Outsourcing-Pharma notes.

As for the United States, FDA currently accepts clinical data from studies conducted at sites outside of the US for products manufactured in the U.S. and imported into the country. However, studies must be conducted in accordance with accepted ethical standards and good clinical practices (GCPs), which are outlined in U.S. and international regulations and guidances.1

If you intend to begin clinical trials in the near future but need help writing a study protocol, consent form, or need IRB approval of your completed protocol, contact us today for support.

 

1https://www.outsourcing-pharma.com/Article/2017/10/11/China-accepting-clinical-trial-data-from-other-countries?utm_source=newsletter_weekly&utm_medium=email&utm_campaign=From%2006-Oct-2017%20to%2013-Oct-2017&c=nscr0mx%2F7rclH4KMfn25z5JonraY%2Bfj0&p22=