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 Under draft guidance released for public comment,...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
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
For this first time since 2018, holders of medical device licenses in Indonesia will be able to apply this year for inclusion in the government’s popular online catalogue, the Indonesia Ministry of Health has announced. The online purchasing system currently lists over... Read More
Medical device manufacturers marketing their products in Malaysia will be required to report to government authorities any events related to their use that could negatively impact patient’s health, under a Medical Device Authority regulation that went into effect on July 1. The... Read More