While RWE is fairly prevalent for US and EU drug companies in their home markets, this has not been the case in Japan. However, according to a recent McKinsey article, this will change in the near future and become a more common... Read More
The Korean government plans to increase Korea’s drug and biotechnology markets by adopting more global standards, implementing positive regulatory policies, and increasing investment. The Korean government hopes to develop a super fund to support its vaccine and new drug development. First, Korea... Read More
On June 1, 2022, Japan’s PMDA‘s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest... Read More
During the last round of price cuts, Chinese drug prices have fallen about 45%, and price reductions have affected close to 300 drugs. In mid-June, China’s National Healthcare Security Administration (NHSA) laid out certain new documents which outline its rules for inclusion on... Read More
In the past, Japan has adjusted drug prices every two years. However, in 2022, the Central Social Insurance Medical Council known as Chuikyo had its first off-year re-pricing. In 2023, Chuikyo will have its second off-year repricing which will take effect in... Read More
On May 9, the NMPA outlined new draft drug reforms. In the new draft regulation, a new drug is not described as new in China or new worldwide as previous legislation did, so it may be more challenging to interpret. This could... Read More
A recent report from the Korea Pharmaceutical and Bio-Pharma Manufacturers Association criticizes the government for continuing to lower drug prices in Korea which hinders the growth of new drug development. The report claims that this government policy only incentivizes drug companies to... Read More
China is trying to make the transfer of personal healthcare data out of China more regulated and formal. Unlike other Asian markets, tissue and blood samples cannot be sent outside of China for analysis. However, personal healthcare data can be sent overseas... Read More
On July 8, the Indian government issued new legislation to get shareholders’ feedback. This legislation started in 2016 and is trying to replace the Drugs and Cosmetics Rules of 1945. New definitions for investigational new drugs, medical devices, clinical trials, etc. were included. New severe penalties... Read More
On June 28, the NMPA said it plans to improve services to foreign medical companies. Primarily, this message is to further help foreign drug and medical device companies with more efficient product registration. Their focus will be primarily on the pediatric and rare disease... Read More