Eighteen months after launching a pilot system to improve the tracking of medical devices, Chinese regulators are starting to build the system out, announcing the first group of products that will be required to employ the Unique Medical Device Identification (UDI) system.... Read More
For the first time in twelve years, Chinese regulators are drafting updates to government regulations on therapeutic and diagnostic products that combine drugs and medical devices. The draft updates released by the National Medical Products Administration (NMPA) include eight major changes designed... Read More
A host of rehabilitative technology companies are entering the Asian market in force, driven by the needs of the region’s aging population for exercise and rehab equipment to combat immobility, muscular atrophy, and the epidemics of heart disease, hypertension, stroke, osteoarthritis, and... Read More
Three years after China launched a national drug bulk-buying program to negotiate lower prices from drug manufacturers, competitive pressure continues to grow on multinational pharmaceutical companies seeking to compete in the vast country’s market. The results of the fourth round of the... Read More
Cancer is a high priority in China. Incidence rates are rising quickly with lung, colorectal, stomach, liver, and breast being the most numerous. China’s local biotech companies are now focusing on cancer especially R&D in immune-oncology and cell therapies. More China biotechs... Read More
Basic health insurance plans in China will begin this year to cover the cost of most drugs used to treat rare diseases, according to a National Healthcare Security Administration statement released in December. Under the plan, rare disease drugs that are proven... Read More
Twenty-nine new drugs produced by Chinese pharmaceutical companies were added to the new National Drug Reimbursement List (NRDL) in January, squeezing out foreign competitors, whose offerings were deemed by review panels to be exorbitantly priced. The success of such a relatively large... Read More
China, Korea, Taiwan, and Japan are rapidly becoming world leaders in cell and gene therapy research and innovation, fueled by significant public and private investment and streamlined regulations that are spurring breakthroughs in the field. All three countries have long been leaders... Read More
Chinese regulators are clamping down on sweetheart deals between drug and medical device manufacturers and hospitals, in an effort to deter corruption that they fear undercuts the quality of the country’s healthcare. Among the actions taken in recent months are legal proceedings... Read More
Moving to standardize and improve the quality of medical devices utilized at health care centers throughout China, the country’s National Healthcare Security Administration is establishing a value-based purchasing platform for the submission and purchase of medical devices. The platform, expected to be... Read More