Although the latest implementing details classify many aspects of human genetic resource handling and transfer, foreign entities are severely restricted from developing gene and gene-editing therapies in China. Legal experts say the changes combined with data transfer and recent cybersecurity legislation pose additional challenges to life science companies operating in the country.
From BGI Genomics Co Ltd. to AstraZeneca PLC to WuXi AppTec, six large health sector heavyweights were fined by the Chinese Ministry of Science and Technology (MOST) for violating human genome resources administration regulations, according to a high-profile announcement in late 2018.
Since then, the Chinese regulatory agency has significantly beefed up its oversight of the area. Beijing has strengthened data transfer...
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
China’s top drug regulator is implementing a pilot program offering shorter review times for IND applications to improve the quality and efficiency of clinical studies and stimulate the country’s innovative drug sector.
Shanghai issues a new set of policies and financial incentives designed to support and speed up regulatory and commercial activities in the biopharma sector, in a comprehensive stimulus package for companies based in the major Chinese city.
Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.
The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
