Every authority update, matched to the products it touches

Revised EU variations framework applies from 15 January 2026

EU implementation strategy published for ICH E2D(R1) post-approval safety data

EMA publishes revised variation classification examples

MHRA marketing authorisation guidance updated with portal and eCTD expectations

Hungary requests local confirmation for class safety implementation

ANVISA introduces accelerated pathway for biosimilars

PRAC minutes highlight class labeling alignment for sedating antihistamines

MHRA portal maintenance window announced for eCTD submissions

MHRA licensing collection reorganized around route, variation, renewal, and transfer decisions

ANVISA updates renewal checklist for imported medicines

URPL clarifies Braille placement expectations for outer cartons

FDA flags accelerated safety labeling review expectations

FDA draft guidance sets validation expectations for new approach methodologies

Health Canada publishes Annex 13 GMP guide for clinical trial drugs

MHRA updates UK national assessment procedure guidance

ANSM requests accelerated Dear HCP letter alignment

PMDA expands remote GMP inspection document requests

Dutch MEB updates national advice on grouped quality variations

DKMA changes expected detail for medicine shortage mitigation plans

Poland requests affiliate confirmation on DHPC distribution evidence

BfArM updates shortage notification evidence expectations

EMA variations page directs MAHs to use IRIS for post-authorisation variation management

AEMPS validation note calls out common eCTD envelope errors

Health Canada posts new NOC entries in prescription drug register

SUKL flags eCTD validation errors in national variation submissions

PEI updates batch release scheduling note before holiday period

MHRA refreshes ILAP documentation expectations for innovation passports

Hungary posts updated administrative fee references