China’s punishing experience with COVID-19 is likely to push forward deep reforms already underway in the nation’s healthcare system, shifting medical diagnosis and treatment away from large hospitals, furthering digitalization and telehealth, etc. That is the conclusion of a new report by... Read More
This article was originally published on FDLI. Introduction China’s drug market has exploded over the last few years, and future growth is estimated at 6-7% over the next five years. Valued at about $140 billion, it is now the second-largest drug market... Read More
As currently drafted, the 2020 Chinese Pharmacopeia, the benchmark publication on the safety and efficacy of pharmaceuticals legally available in China, includes 319 new entries. The publication includes more than 5,500 traditional Chinese and Western medicines. The official compendium of the standards... Read More
A 2016 law that allows the administration of unapproved drugs in Japan when they may aid patients suffering from an otherwise fatal disease may be utilized to test COVID-19 treatments in the country. Known as the “compassionate use” system, the law permits... Read More
With the COVID-19 pandemic impacting clinical trials worldwide, Singapore is among the countries that have issued guidance for sponsors, investigators, and review boards on handling trials that were already in progress. Under the guidance issued by Singapore’s Health Sciences Authority (HSA), sponsors... Read More
Even as the COVID-19 pandemic has hit some regions of China with intensity, clinical trials of investigational drugs have continued, with government authorities instituting strict controls on protocols and methods to ensure patient safety and the efficacy of trial results. Guidance by... Read More
As health care firms in China and Hong Kong race to respond to the challenges of the global COVID-19 pandemic, they are experiencing sustained investment (mostly from China funds and wealthy Chinese investors), and are benefiting from recent regulatory changes and technological... Read More
Earlier in March, the Chinese NMPA issued new regulations for API DMFs in China. Now, DMF manufacturers need to pay the NMPA about $50,000 to get their APIs activated in China whereas there used to be no government fee. Also, more documents are needed. The following documents and samples are required... Read More
Medical institutions in Shanghai that provide online diagnosis and treatment during the COVID-19 outbreak will now be eligible for reimbursement by China’s national health insurance authority. Under a pilot program, services to be covered include online follow-up consultations for common and chronic... Read More
Pharmaceutical companies seeking to deepen penetration of Singapore’s market are coming up against barriers to ensuring their intellectual property is protected and to keeping down costs of conducting clinical trials. The pharma industry is rising in importance in the country’s manufacturing sector.... Read More