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Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our... Read More

In an effort to improve the quality of medical devices on the Chinese market, the NMPA, led by the National Institutes for Food and Drug Control (NIFDC), will do sampling inspections at various healthcare facilities. Sixty-six product types will be sampled including products... Read More

The Chinese NMPA is very interested in increasing the number of drugs approved in China each year to better serve its citizens. Over the last 8 years, since China joined the ICH and implemented a number of streamlined drug registration regulations, annual drug registrations... Read More

Chinese patients want more drugs to treat their diseases. With over 1.4 billion Chinese people and with more than 350 million people in China’s middle class, there is enough disposable money to pay for them. To get more drugs approved in China,... Read More

Over the last 5 years, getting drugs registered in China and available for sale has become more efficient, easier, and a lot quicker. However, China drug pricing is still a major concern. Two drug price reduction schemes are outlined below.  First, one... Read More

As mentioned last year in our news brief, China initiated a significant corruption crackdown in 2023. This crackdown was escalated again late last year when China’s National People’s Congress promulgated the 12th amendment to its criminal code. Starting last month (March), penalties... Read More

Most drug and medical device executives know that getting Human Genetic Resources (HGR) from China is not an easy task. However, over the last year, China has implemented changes to make this a somewhat easier process. For example, data can be transferred... Read More

As mentioned last year in our news brief, more and more Western drug companies are looking for new products in China. This trend has continued in 2024 as over 19 transactions valued at more than $18 billion USD were consummated in January... Read More

On February 5th, China’s National Healthcare Security Administration (NHSA) made public a declaration titled – Establishing a Price Formation Mechanism for newly-listed chemical drugs to encourage high-quality innovation. Basically, the Chinese government acknowledged that in its pricing process, highly innovative and less... Read More