Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to authorities, the National Medical Products Administration (NMPA) announced in August. The periodic risk assessment reports, which outline... 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 the wake of a 2019 antibiotic shortage which cast light on the country’s dependence on overseas suppliers of the essential drugs, Japan’s Ministry of Health, Labor and Welfare is proposing a series of measures to ensure stability in its supplies of... Read More
South Korea is pushing to standardize international regulations on medical devices fueled by artificial intelligence technologies and to eliminate structural barriers to marketing those and other innovative medical device technologies. In July, Eui-Kyung Lee, who heads Korea’s Ministry of Food and Drug Safety, pushed... 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
Chemical and biologic drugs are required to be classified into new categories for registration in China under new guidance issued by the Center for Drug Evaluation of National Medical Products Administration. Under the new classification system, which went into effect on... 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
One year after China strengthened regulations on the use of human genetic materials in clinical trials, new reporting requirements would make the regulations even more stringent – and more challenging for multinational pharmaceutical and medical device companies conducting such trials in China.... Read More
Medical devices that pose the highest risk to patients’ health would face stricter clinical trial mandates in China under regulations newly drafted by China’s National Medical Products Administration (NMPA). The draft regulations affect Class III medical devices with life support to sustenance... Read More
With the COVID-19 pandemic cutting deeply into revenues of healthcare providers across Japan, health authorities are considering postponing cuts to prices for pharmaceuticals offered by the country’s nationalized health insurance system scheduled to go into effect next April. The scheduled price cuts... Read More