In a boon to people in China with chronic illnesses, the country’s drug regulator will now consider adding clinical trial exemptions for medicines that aren’t yet available domestically but have proved to be safe and effective in overseas markets.
According to a notice Monday from China’s Center for Drug Evaluation, brand-name drugs that are already accessible overseas can be considered for such exemptions if they’re found to be safe and effective, and to not have adverse effects across different races.
The notice is an attempt to address the urgent need among Chinese patients for certain types of medications. Cancer and rare disease patients, for example, are among those desperately seeking hard-to-find drugs.
For drugs that are already accessible in China, when new usage models or administration routes are approved overseas, Chinese drug regulators may consider exempting them from further clinical trials, depending on the overseas clinical trial data.
According to the notice, for generic versions of drugs accessible abroad but not domestically, new clinical trials may be necessary in China if the complete clinical trial data of the brand-name drug a generic drug is based on can’t be obtained.
“That means there’s no good news for generic drugs in this document, which mostly stands to benefit innovative (brand-name) drugs,” He Xiaobing, CEO of Beijing Memorial Pharmaceutical, a Chinese firm that specializes in coordinating clinical trials between China and India, told Sixth Tone.
Previously, it used to take Chinese authorities at least six years to approve drugs that were already accessible abroad, according to the state-run People’s Daily newspaper. But in October 2017, a major policy change instituted an approval procedure of foreign drugs and medical equipment deemed to be urgently needed in the domestic market. The policy stated that, for the first time, China’s drug regulators could consider overseas clinical trial data when granting new approvals.
“The purpose of this move is to avoid repeated tests, bring down the cost of research, and improve efficiency in making these new drugs accessible to Chinese patients,” an official with the country’s drug regulator explained at the time.
Since then, the number of new drug approvals has increased dramatically. In 2018 and 2019, China greenlighted 61 and 58 imported drugs, respectively, including new uses for previously approved imported drugs, compared with just 13 in 2016.
Editor: David Paulk.
(Header image: People Visual)