Continuing to refine its nascent laws regulating the sale of medical devices and IVDs, Vietnam’s Ministry of Health in March drafted new legal parameters that tighten controls on classifying, testing, and conducting clinical trials of medical devices. As drafted, the new regulations... Read More
More than two dozen medical devices with documented track records of safety are now exempt from the clinical trials previously required of the Chinese authorities, saving manufacturers of the devices the expense of conducting the costly trials in order to be approved... Read More
The combination of a relatively low–cost workforce and increasingly reliable quality and ethical standards is turning the Asia-Pacific region into a hub for clinical trials. With pharmaceutical firms under growing pressure to provide innovative new products at reasonable prices, the region is becoming more... Read More
In a push to speed drug approval times amid the coronavirus pandemic, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is finalizing plans to permit drug companies to supplement or replace their own clinical trials with data from patients who have taken the... Read More
Globally, there has been a trend toward using more real-world data in the development of drugs and devices. Japan’s MHLW is also taking note and has drafted 2 new guidelines – 1. A basic policy on using registry data in registration submissions... Read More
China’s Center for Drug Evaluation has clarified its requirements for how pharmaceuticals manufactured outside its borders are tested in clinical trials. Under the new requirements, China’s Center for Drug Evaluation (CDE) will continue to permit the importing of drugs successfully evaluated in... Read More
Introduction to China’s Drug Market Everyone has been talking about opportunities in China’s drug market the last 5 years. While the size of the drug market in China varies, we estimate it at about $140 billion dollars now and growing about 10%... Read More
Changes to pharmaceutical registration regulations in China that went into effect July 1 make clear that Market Authorization Holders designated by the country’s regulatory authority to market or distribute a product are responsible for the safety, quality, and efficacy of that product... Read More
In a bid to better standardize its assessment of medical devices, China’s Center for Medical Device Evaluation has published revised catalogs of medical devices and in vitro diagnostic reagents that are exempt from clinical trials. The “New and Revised Catalogue of Medical... Read More
Seeking to align Taiwan’s pharmaceutical clinical practice methods with international standards, the nation’s top health safety agency is strengthening its protocols for review and approval of new drugs. Starting July 1, 2021, Taiwan’s Food and Drug Administration (FDA) will require that... Read More