Introduction to China’s Drug Market Everyone has been talking about opportunities in China’s drug market the last 5 years. While the size of the drug market in China varies, we estimate it at about $140 billion dollars now and growing about 10%... Read More
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 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
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
Moving to increase the provision of critical healthcare services throughout its vast territory, China’s National Health Commission plans to convert hundreds of community health clinics around the country into hospitals. Under the plan, the community health centers will continue to serve... Read More
This article was originally published on Medtech Intelligence Some Asian countries are racing to ease import restrictions for needed goods that could save lives. Also, the Asian private sector is unveiling a raft of new artificial intelligence, telehealth and data privacy technologies,... 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
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