On June 5, Hong Kong’s Department of Health (DH) announced the establishment of the Preparatory Office for the Hong Kong Centre for Medical Products Regulation (CMPR). This initiative seeks to enhance the regulatory and approval processes for pharmaceuticals and medical devices in... Read More
The Health Science Authority (HSA) of Singapore has released a new guideline to streamline the approval process for next-generation medical devices, which allows manufacturers to leverage data from previously registered devices. Medical devices often undergo enhancements based on real-world feedback and share... Read More
Vietnam’s Ministry of Health (MoH) has promulgated Circular 05/2024/TT-BYT, which details guidelines for acquiring pharmaceuticals, medical devices, and testing equipment through price negotiations. This move follows the 2023 Law on Tendering, effective since January 2024. Over 600 drugs and 4 medical devices... Read More
As noted in previous news briefs, there has been a drug lag in Japan which the Japanese government is trying to shorten. In an effort to improve the overall drug market, the Japanese MHLW has called for an increase in the number... Read More
In response to the outcomes of the MDA-CAB 2024 Workshop held on March 1, 2024, significant changes are underway in the medical device certification/registration process in Malaysia. According to an email from the Medical Device Authority (MDA) dated April 1, 2024, new... Read More
In an attempt to help innovative drug developers get payback for their R&D efforts to bring new innovative drugs to the market and get compensated fairly, both Japan and China have initiated some new innovative drug pricing plans. In late May, the... Read More
Last Fall, the Indian CDSCO said that high risk Class C and D medical devices could not be sold without an import/manufacturing license after September 30. Risky Class C and D products included – surgical robotic devices, linear accelerators, imaging equipment, etc.... Read More
In late March, Singapore’s HSA promulgated a number of updates for the registration of drugs. First, from April 2024, the HSA will look at a pilot program to use e-labeling for pharmacy-only and generally listed therapeutic products – in addition to RX... Read More
Importers who purchase and bring into Thailand foreign drugs need to get those imported drugs registered in Thailand before they can be sold. One of the requirements for Thai drug registration is foreign drug facilities must meet GMP standards. Recently, the Thai... Read More
Recently, India’s Department of Pharmaceuticals (DOP) has set up a new five-person committee to further discuss drug and device prices. While Indian drug price caps have been in place for a while, only a few device price controls (out of 6,200 devices)... Read More