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
New rules being considered by South Korea’s Ministry of Food and Drug Safety (MFDS) would make it easier to investigate the safety of high-tech cell therapies and genetic treatments, as well as other biopharmaceutical products, before they are approved. The new screening... Read More
Clinical trials of drugs, drug therapies, vaccines, and diagnostic procedures in China will for the first time be aligned with internationally accepted regulatory practices under standards which went into effect July 1. The standards, under development for some time and first released... Read More
With COVID-19 cases on the rise in the Philippines and around the world, the country’s regulatory authorities are considering temporarily suspending the practice of on-site foreign inspection of pharmaceuticals intended for sale in the country. Under draft guidance released for public comment,... Read More
A new medical insurance payment system piloted in China since October 2019 is being refined to better standardize the way the scheme is carried out, the National Medical Products Administration (NMPA) has announced. The plan, the diagnosis-related group pilot payment system (DRG),... Read More
Showing flexibility in the face of the needs presented by the COVID-19 pandemic, health authorities in Singapore are facilitating the approval of medical devices used to decontaminate respirators. In establishing the provisional authorization pathway for the Class C devices, the Health Sciences... Read More
China’s pharmaceutical regulatory agency has changed the way it categorizes chemical and biologic drugs, according to a series of notifications that went into effect July 1. The new drug registration categories released by the National Medical Products Administration (NMPA) better delineate the... Read More
Moving to further strengthen the safety management of medical devices that are implanted into the human body, the Ministry of Food and Drug Safety is instituting a new tracking system called – “Implanted Medical Device Safety Information Check System” – which will go into... Read More