China now accepting clinical trial data from other countries
The new guideline was issued (in Chinese) by the General Office of the Communist Party of China Central Committee and the General Office of the State Council earlier this week.
According to a post by the State Council, the guideline aims 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.”
“Management of clinical trials 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 trials,” according to the post.
A draft of the new policies was released earlier this year at which time Philip Gregory, managing director at George Clinical told us if implemented, the changes would “standardize regulatory requirements, allow for greater use of foreign data broadening eligibility of sites to conduct trials, provide greater transparency of the ethics process, and ultimately shorten approval times.”
The China Food and Drug Administration (CFDA) did not respond to a request for comment
The FDA's position
The FDA accepts clinical data from studies conducted at sites outside of the US for products manufactured in the US and imported into the country.
“The designs of trials carried out in the US and elsewhere are generally similar, following specifications in US regulations and guidance as well as advice in documents developed under the auspices of the ICH, and transmitted to sponsors during drug development,” an FDA spokesperson told us.
However, studies must be conducted in accordance with accepted ethical standards and good clinical practices (GCPs), which are outlined in US and international regulations and guidance.
“As described in FDA guidance, a sponsor of a marketing application should explain how foreign clinical data are applicable to the US population and US medical practice,” the spokesperson added.
Strengthening clinical trial operations
The CFDA has made several changes over the past year as the agency “is trying its best to strengthen clinical trial operations,” Rong Zhang, MS, deputy chief technician at the CFDA said in June at the DIA Annual Meeting.
As part of this, the agency also recently announced membership in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Additionally, a Marketing Authorization Holder (MAH) program is being piloted across ten provinces and municipalities in China. “The pilot allows more stakeholders to be a part of pharmaceutical development,” an US Food and Drug Administration (FDA) spokesperson told us in July.
