A plethora of new and revised regulations in China to regulate drug distribution and storage, the set up of new corporations, administrative appeals, as well as the export of gene editing technology, are set to come into effect in 2024, ushering in more challenges to pharma and life sciences companies operating in the country.
The year of the ox in 2023 brought many uncertainties to the pharma sector in China, but as we move to the year of the dragon in the 12-year Chinese zodiac cycle, the outlook is for multiple further changes in the country's biopharma policy and regulatory environment.
Last year saw a flurry of challenges, ranging from a continuous tightening of rules on the management of human genetic...
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.
