Medical devices marketed and distributed in Singapore have long been subject to strict requirements that mandate any safety hazards associated with their use be reported to government authorities. Now a new online system makes reporting of what is known in Singapore as... Read More
Spurred by the coronavirus crisis, China is moving for the first time to permit first-time medical diagnoses to be conducted online. The move by China’s National Development and Reform Commission (NDRC) is part of a major new push to move many healthcare... Read More
Regulations on in-vitro diagnostic (IVD) products in South Korea that took effect in May establish a broad set of registration requirements as part of a push to improve oversight of their safety and quality. The regulations, the first in South Korea to... Read More
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
Moving to better ensure the safety of medical devices available in China, the National Medical Products Administration (NMPA) in April announced it will implement random inspection regimens on the manufacture, management, distribution, and delivery of such devices already on the market. Under... 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
New regulatory guidelines released by Singapore’s Health Sciences Authority outline specific requirements required to register next-generation sequencing-based in vitro diagnostic tests, known as NGS IVDs, in the country. The new registration regulations are designed to address rapid advances in genomic technology that... 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
Pharmaceuticals produced in Indonesia will be required to contain a higher percentage of domestic materials, under a government mandate under development. The directive from the Indonesian Ministry of Industry is designed to move Indonesia away from its heavy dependence on imported materials,... Read More