Two years after Japan began employing a cost-effectiveness evaluation system to determine the efficiency and allocation of health resources, it is preparing for the first time to adjust prices of pharmaceuticals and medical devices based on such assessments. Japan’s Central Social Insurance... 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
With the COVID-19 pandemic making it unsafe to conduct most on-site inspections, regulatory authorities in Malaysia are permitting remote assessments of some pharmaceutical manufacturing facilities outside the country. Malaysia’s Guidance Document on Foreign GMP Inspection, 7th edition, March 2021, published by Malaysia’s... 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
A decades-long push by Japan to spur innovation in its pharmaceutical industry is expected to get new life this year, with government health agencies planning to release by this summer a new set of goals for speeding clinical trials and encouraging the... 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
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