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
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
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
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
Being a local agent for medical device products in China is going to get significantly more rigorous. Some of the new requirements now in draft form, will be implemented soon. According to the new regulations, the NMPA organized the drafting of “Measures... Read More
China is drafting plans to increase penalties on pharmaceutical companies that manipulate prices, sell counterfeit drugs or otherwise violate pharmaceutical laws. The plans include a credit rating system to incentivize drug firms to lower prices in exchange for access to China’s vast... Read More
Aging populations and increased incidences of chronic diseases across the Asia-Pacific region are spurring rapid growth in demand for in-vitro diagnostic (IVD) testing. That presents major marketing opportunities for the diagnostics industry in China, India, Southeast Asia, Japan, South Korea, and Indonesia. ... Read More
The COVID-19 pandemic is hampering the initiation and progress of clinical trials in Asia and around the world. Few patients are entering studies, and trials of new treatments are on hold. In Korea, the number of new patients enrolling in clinical... Read More
China is increasingly emerging as a global leader in cell and gene therapy innovation, with the government granting thousands of patents in the field, and Chinese laboratories already conducting or scheduled to begin more than 1,000 clinical trials over the next two... Read More
Driven by the needs of its aging population, demand in China for rehabilitation services and institutions is growing rapidly. From treatments for strokes, brain damage, spinal cord injuries and other neurological disorders to post-operative rehabilitation for orthopedic and cardiac patients, the need... Read More