Compliance Concern

In order to better understand the current status of clinical trials for new drug registrations in China; to disclose clinical trial progress information to the public; to provide reference for new drug research and development (R&D), resource allocation, drug review and approval for the industry; and to explore the use of informatization technology to improve the ability of intelligent supervision of drugs, the Center for Drug Evaluation (CDE) has conducted the first comprehensive summary and analysis of clinical drug trials in China according to data from the Drug Clinical Trial Registration and Information Disclosure Platform.

It is our common understanding that the success of a global clinical study depends often on selecting the right country, with considerations of medical infrastructure, research experience and accessible patient population. Korea, recently became a role model for boosting clinical industry, has been recognized as hub of healthcare innovation and the leading clinical trial destination in the Asian region.

While Chinese regulators have been receiving more IND filings for oncology drugs, treatment targets and indications have been jammed into a few choices, such as PD-1/L1 and VEGFR. Regulators are now trying to turn things around with a top-down approach.