Short signals on regulatory, pricing and procurement shifts, and what they change.
Council adopted its first reading positions and Parliament referred the file to committee. Nothing is law yet, and the date that matters is 2028.
A petition to drop premarket notification for radiology computer-aided detection and diagnosis devices was refused, not granted.
Circular 32/2026/TT-BYT took effect on 1 October, and the recognised set of regulators is wider than the six usually quoted.
The 100 percent Section 232 tariff extended to all companies on 29 September, and Commerce published the architecture that decides who pays nothing.
International reference pricing enters Medicare Part B by final rule, with a later start and a much shorter list of drugs than proposed.
A 100 percent tariff on imported patented medicines is operative for a first group of companies, and applies to everyone else from 29 September.
WHO and the African Medicines Agency signed a framework to drive regulatory reliance across the continent.
An abbreviated assessment route opens for products already approved by one of six named authorities.
NICE's cost-effectiveness range moved for the first time in two decades, and the Secretary of State can now direct it.
A new GB route recognises US, Canadian and Australian approvals. Not European ones.