Last week, the CFDA began circulating draft proposals for broad-based reforms that will bring China’s drug regulatory system closer to western procedures. Among other changes, the CFDA plans to begin approving INDs automatically if the agency doesn’t issue a ruling within two months -- a much shorter timeline than the current practice. It will also allow conditional access to better treatments for rare diseases after Phase I trials. The agency loosened its controls over China clinical trial sites and improved IP protection of novel drugs. And the National Reimbursable Drug List will be updated continuously (the February update was the first in eight years).
