The Ministry of Health, Labor, and Welfare (MHLW) in Japan plans to start a new initiative aimed at boosting the skills of inspectors working under the Good Manufacturing Practice (GMP) guidelines. This initiative will involve sharing inspection reports from across the nation,... Read More
Starting February 14, 2024, the Thai FDA has enhanced its medical device registration requirements. Prior to this new regulation, medical devices generally only required a partial ASEAN Common Submission Dossier Template (CSDT), but now a full CSDT is required. The Thai FDA... Read More
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned into a JIS standard in 2019 and was updated as JIS T62366-1:2022 in February 2022. JIS T 62366-1... Read More
Earlier this year, the Indian government issued a notification upgrading its drug manufacturing requirements. This notification said that large Indian drug manufacturers had 6 months to upgrade their game, smaller Indian drug makers had 12 months. The notification said Indian drug makers... Read More
On January 4th , China’s National Healthcare Security Administration Office promulgated the — Medical Centralized Procurement Platform Service Standards. This legislation follows the National Healthcare Security Administration’s Opinion on Improving and Enhancing the Functions of Medical Centralized Procurement Platform to Support Pharmaceutical... Read More
Starting in July, China’s NMPA will enact its revised policy on quality medical standards for medical operations. The old version issued in 2014 will no longer be in use. The new measures cover a variety of topics for good supply management. For... Read More
On March 1, 2024, new regulations governing drugs imported into Thailand for clinical studies will come into effect, transforming Thailand’s clinical trial landscape. These regulations introduce a detailed framework for the importation of drugs for clinical studies. Notably, while there were no... Read More
The Malaysia Medical Device Authority (MDA) has introduced a landmark guidance document aimed at streamlining post-market surveillance and data exchange across the Association of Southeast Asian Nations (ASEAN). This initiative, outlined in the guidance MDA/GD/0067, is in response to the collective decision... Read More
Japan has always been a good orphan drug market with high reimbursement and oftentimes government financial support for development. However, in the past, it was not flexible on designation unless 3 criteria were met – 1. the drug had to treat fewer... Read More
Everyone knows China is a big medical market. Many large and small healthcare companies are still doing well there. However, for a variety of reasons, the China opportunity is tougher to capitalize on today. For medical devices, China’s policy – Buy China... Read More