China Looks to Change Import Drug Registration System

The Chinese FDA is proposing to relax restrictions on imported drugs by no longer requiring that foreign drugs be approved abroad, or in late-stage clinical trials, before an international multi-center trial can be started in China to seek an approval.

Under the proposal, a drugmaker can apply to market an imported drug or biologic that has been studied in a multi-center trial in China — without having a prior approval in another country or being evaluated in a Phase II or III clinical trial, according to the law firm Sidley Austin.

The proposal, which does not apply to vaccines, represents a major shift in the country’s import drug registration system, and is intended to speed access to imported drugs, the law firm said.

Previously, an imported drug had to be approved in a foreign market before seeking an approval in China. But that often took several years, and delayed access to treatments not yet approved for marketing in Europe and the United States.