China hunts for $88M in vaccines diverted to black market
Chinese authorities have arrested a mother-and-daughter team that is accused of illegally buying nearly $90 million worth of vaccines from producers and selling them on the black market.
Boehringer Ingelheim wins first client for China biologics plan
While other drugmakers were building plants in China to make their own medications, Germany's Boehringer Ingelheim saw an opportunity to build one to cater to Chinese companies working on cell-based products. Boehringer now has its first client.
Most devices will need Chinese clinical trial to secure CFDA approval: Consultant
The China Food and Drug Administration has issued more than 20 guidance documents on medical device regulation over the last two years as it tightens its oversight of the device industry in the fast-growing market. The chief concern and area of uncertainty revolves around the country's clinical trial regime, especially for devices that are not on an "exempt list." Adding to the confusion, some devices on the list may still require a clinical trial, while others not on the list could get registered and approved without a trial.
UPDATED: China FDA on the hunt for illegally sold vaccines in Shandong
A mother-and-daughter team allegedly behind a massive illegal sale of vaccines in Shandong province are under arrest as China FDA moves to track down the potentially harmful supplies by calling for immediate help from manufacturers and distributors.
Reproductive medical services in China sprout post one-child policy
It remains early days after China's move to abandon the one-child policy, but China Daily reports that efforts to provide reproductive services to potential parents are growing with a focus on older couples.
EMA cites another China plant for manufacturing, data flaws
While the FDA has repeatedly run into resistance to beef up its inspectors in China, the European Medicines Agency (EMA) has regularly sidelined plants there. It does this by sharing inspection results from each EU country with all of its members.
China halts track-and-trace project because of complaints against Alibaba
China's FDA has put a moratorium on an electronic drug tracking system after a lawsuit was filed alleging that Hong Kong-listed Alibaba Health Information Technology, or Ali Health, which is designing it, was gaining an unfair trade advantage over other drug sellers.
FDA allows banned China plant to ship chemo API that is in short supply
A Chinese drugmaker has caught a break from the FDA, which needs its help in the face of a shortage of a chemo drug often used to treat AIDS-related Kaposi's sarcoma.
China renews consolidation drive for drug manufacture, wants TCM push
China's leadership renewed a push to winnow out bad quality drug manufacturers and improve safety as part of a State Council meeting that updated on an ambitious program of healthcare reforms calling for access to newer therapies and greater use of traditional Chinese medicines (TCM).
China healthcare exports need marketing, quality push after acquisitions: L.E.K.
Shanghai-founded MicroPort, or fellow China-based Mindray Medical, are not exactly household healthcare names--but along with other players they are China's leading device and healthcare service firms abroad and are a growing competition to multinational and local companies.