• 2026-04-28 02:04:20

The FDA has opened "Fast Track" channel for changes notifications for manufacturers of essential medical devices who face unavoidable supply chain disruptions in raw materials and packaging materials.
These changes notifications can be reviewed more rapidly by officials than standard change notification, to support manufacturers during the crisis.

• 2026-01-30 05:41:43

The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore's Health Sciences Authority (HSA) have created a first‑of‑its‑kind Regulatory Innovation Corridor, launched on 12 December 2025. This coordinated fast‑track pathway allows developers of breakthrough medicines and medical devices to engage both regulators simultaneously. By offering coordinated feedback early in development, it seeks to streamline clinical trials, reduce duplication and accelerate patient access to promising therapies in areas such as cancer, dementia, obesity, rare diseases and advanced diagnostics. Further detail on the new fast track pathway have not yet been published by HSA.

• 2021-06-25 12:32:37

While the channel of distribution of a COVID-19 vaccine under the conditional approval scheme is rigorously controlled by the Thai FDA, a fast-track approval route was launched exclusively for more COVID-19 products even under the implementation of risk-classification regulation.

• 2020-11-26 10:19:14

Japan has introduced a set of changes, aiming to market innovative products as fast as possible to help patients in Japan with deadly diseases. One of the changes implemented is Fast-Track Approval Scheme.