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China’s National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MHRSS) announced in mid-January the drugs added to the 2022 NRDL. In exchange for drug reimbursement, an average price cut of about 60% was accepted by these... Read More

Since 1999, Japan’s MHLW has had strict restrictions on the disclosure of Japanese drug clinical trial information to non-medical audiences. Information like the name of the investigational drug or the specific clinical trial code was not available. On January 24 this all changed. Now,... Read More

In March 2021, the NMPA promulgated a regulatory notice on device master files. On January 18, 2023, they issued another notice titled – Further Clarity on the Registration and Use of Medical Device Master Files. Device Master Files are used to protect... Read More

On January 13, various members of the Japanese Health ministry met and discussed the need to improve orphan drug designation and approval. Increased funding for orphan drug development was debated. Orphan drug designation (ODD) can be achieved in the West with Phase... Read More

For medical device registration in China, after a dossier is reviewed by the CMDE, additional information is almost always requested during the supplemental submission phase. Requested information can include things like additional supporting documents, more technical information, corrections of translations, etc. In January 2020,... Read More

About 2 years ago, China implemented its patent linkage system. Geared towards helping foreign companies to bring new drugs to China and helping local Chinese generic companies promote their products, to date, about 30 patent linkage cases have been reviewed by the... Read More

While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will... Read More

By March 3, 2023, Singapore’s HSA has requested industry comments on proposed device labeling for cybersecurity. The draft cybersecurity labeling scheme for medical devices (CLSMD) was initiated in late 2022 by the HSA, MOH, and Integrated Health Information Systems. Today, more medical... Read More

In late 2022, the Korean Pharma Association did an evaluation of over 200 drugs that were approved in Korea between 2011 – 2022. Western countries and Japan have been able to reduce the review times for new drug approvals, but during this... Read More