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China-US Health Regulatory Dialogue In Crosshairs Amid Biden-Xi Summit

PIC/S Membership Meets Political Pressure

 
• By Brian Yang
  
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Beijing’s application to join an international pharma inspections scheme offers a rare opportunity to revitalize a largely downsized US-China dialogue, but domestic pressure and public opinion may jeopardize the opportunity.

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China's PIC/S membership application offers rare US-China health collaboration amid Biden-Xi Summit • Source: Shutterstock

Once hailed as among the first countries to open its doors to the US Food and Drug Administration's inaugural overseas offices, China is now having very little if any communications with the US on health policies. This has worried industry observers, who see the lack of dialogue as unhelpful to resolving the plethora of issues facing the two largest economies in the world.

From fentanyl to opioids and other narcotics, from public health science exchange to funding basic research, from US pharma firms'...

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Coping Strategies For China Industry Amid BIOSECURE Overhang

 
• By Xu Hu

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."

Califf: Not Wise To Create Problems Related to Chinese Pharma Supply Chain Dependence

 
• By Sarah Karlin-Smith

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 Pilots Scheme To Halve IND Review Time For Innovative Drugs

 
• By Dexter Jie Yan

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.

$14m Handout Anyone? Shanghai Offers Raft Of New Biopharma Incentives

 
• By Brian Yang

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.

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Easing Market Entry: Japan’s PMDA Allows Approval Filings In English

 
• By Lisa Takagi

Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.

Akebia’s Vafseo: Japanese Postmarketing Data, Narrowed Indication Eased Liver Toxicity Worries

 
• By Sue Sutter

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.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By Vibha Sharma

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.