The recent arrest of a local Japanese employee of Astellas triggered alarms for pharma firms operating in China, while a newly-expanded and wide-ranging anti-espionage law means that sponsors must pay careful attention to overseas data transfers, especially related to clinical trials, business intelligence and due diligence, as well as other activities.
On 26 April, the Standing Committee of China’s National People’s Congress passed into law the latest expansion of wide-ranging anti-espionage legislation, in the central government's latest move to prioritize national security ahead of economic growth.
The move was especially significant given that in March, major Japanese pharma firm Astellas Pharma, Inc. acknowledged that one...
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.
