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New plans unveiled to legally import unapproved lifesaving drugs

By Wang Xiaoyu | | Updated: 2022-06-29 17:19
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China has formulated a plan to facilitate the import of Clobazam, an unapproved epilepsy drug, to address acute medical demand, the National Health Commission said on Wednesday.

Along with the National Medical Products Administration, the commission has also released a guideline that applies to all medications approved abroad, but which are currently unavailable in China, and which are in need in small quantities.

"The two plans will help resolve the special medical demands of some patients, and will also help guide their proper clinical use and ensure drug safety," the commission said in a statement explaining the documents.

It added that it encourages domestic pharmaceutical manufacturers to accelerate plans to make generic versions of these drugs, and supports foreign drugmakers applying for market approval.

China lists Clobazam as a second category psychotropic drug, meaning that it is potentially addictive and must be strictly controlled.

Clobazam has drawn widespread attention since November last year when families of some 1,000 child sufferers of epileptic encephalopathy — a rare and severe brain disorder that often occurs at an early age — pled in an open letter for expanding access to the lifesaving drug.

Parents had previously procured Clobazam from abroad via shopping agents or online orders, but months of crackdowns on the flow of drugs via mail cut off their only access to the medicine.

In November, a mother in Zhengzhou, Henan province was investigated by local public security officials for drug-trafficking after receiving a package containing Clobazam.

The commission said that it has worked with other government departments since 2019 to create a mechanism to ensure sufficient supplies of drugs. Widespread, long-term shortages of certain medicines are increasingly rare in China.

However, the country's massive population and complicated disease profiles have made securing sufficient supplies of drugs more challenging in recent years, the commission said.

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