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
Singapore’s cybersecurity head, Mr. David Koh, said it will increase its cybersecurity approach via a new labeling plan and reinforce its operational technology platforms. Devices that track personal data and have the ability to collect, store, and process such data would be... 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 Korean government for continuing to lower drug prices which hinders the growth of new drug development. The report claims that this government policy only incentivizes drug companies to make... Read More
China is trying to make the transfer of personal healthcare data out of the country 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... 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
On June 16, the Filipino FDA issued circular 2022-0045 named “Establishing Facilitated Registration Pathway for Drug Products”. This circular discussed how Reference Drug Regulatory Agencies (RDRA) can expedite drug, vaccine, and biologic approvals in the Philippines. If an RDRA has approved a... Read More
RWE or real-world data are now becoming more important for drug and medical device approvals and reimbursement in China. Since 2019, when Hainan Island released regulations emphasizing the value of RWE, similar RWE regulations have also been issued by the NMPA for... Read More