Last summer, the Japanese MHLW issued guidelines saying the PMDA and the prefectural authorities should do surprise GMP inspections on factories that have had many previous problems. The surprise GMP inspections were to stop factories from covering up sensitive issues before inspections.... Read More
On March 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical... Read More
On March 31, the Japanese MHLW issued a notification allowing CDxs to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs that have identical indications. ... Read More
In an effort to accelerate the medical device registration process, the Taiwan Food and Drug Administration (TFDA) has launched in January the TFDA Medical Device Pre-Market E-Submission System, which enables manufacturers to submit documents for their pre-market applications and renew licenses digitally. The new online... Read More
Singapore’s Health Science Authority (HSA) recently announced regulatory updates pertaining to the two Special Access Routes GN-26 and GN-27. GN-26 allows licensed healthcare providers to import unregistered medical devices to use on their patients. GN-27 allows licensed importers to import unregistered medical... Read More
The China NMPA recently announced that the updated China Good Clinical Practice (GCP) for Medical Devices will come into effect on May 1, 2022. The GCP was promulgated in 2016 in order to ensure the quality of medical device clinical trial management,... Read More
The Filipino FDA is now circulating a document that will allow abridged processing of device applications in the Philippines if the device has already been approved in another ASEAN country. Abridge processing refers to a quicker evaluation with respect to AMDD-CSDT requirements.... Read More
Global regulators are increasing their watch on antitrust issues, pricing issues, IP, patent laws, etc. China’s regulators are doing the same and earlier this year issued 2 policy reports – The Fourteenth Five Year Modernization of Market Regulation Plan and the Fourteenth... Read More
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) announced that it will implement a new good pharmacovigilance (GVP) inspection program at the beginning of 2023 with a voluntary phase. These inspections ensure that manufacturers of pharmaceutical products and their affiliates conform to the... Read More
Reimbursement for medical devices in Japan is determined by functional pricing and foreign reference pricing. Every 2 years the Japanese government issues new medical device pricing in April. This year, the reimbursement for their foreign reference pricing formula will be reduced as... Read More