MHRA and NICE launch an aligned pathway to publish regulatory and health technology assessment decisions simultaneously

The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway. This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce…

Read MoreMHRA and NICE launch an aligned pathway to publish regulatory and health technology assessment decisions simultaneously

New FDA process to facilitate approval of drugs to treat rare diseases in very small patient populations

On 3 September 2025, FDA’s CDER and CBER proposed a new process under Rare Disease Evidence Principles (RDEP) to facilitate the approval of drugs to treat rare diseases with very small patient populations with significant unmet medical need and with…

Read MoreNew FDA process to facilitate approval of drugs to treat rare diseases in very small patient populations

MHRA guidance on medicines MAH submission of nitrosamine risk evaluation, risk assessment and confirmatory testing updated

This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…

Read MoreMHRA guidance on medicines MAH submission of nitrosamine risk evaluation, risk assessment and confirmatory testing updated

Swissmedic updates to guidances on time limits for authorisation applications, formal requirements and product information

In this post, information is provided on the following updated guidance documents: Changes to the guidance document Time limits for authorisation applications Swissmedic is shortening the procedural time limits for applications for new authorisation of medicinal products with known active…

Read MoreSwissmedic updates to guidances on time limits for authorisation applications, formal requirements and product information