ARQonSep 1, 20232 minUSA: FDA Released Guidance for Enhanced Drug Distribution Security Requirement (27 November 2023)FDA published guidance to comply with the requirements of the enhanced drug distribution security, under Section 582(g)(1) of the Federal...
ARQonAug 30, 20232 minChina: CMDE Reworks the Medical Device Classification CatalogueOn 15 August 2023, the State Food and Drug Administration under the Centre for Medical Device Evaluation (CMDE) announced the adjustment...
ARQonAug 29, 20231 minSouth Africa: SAHPRA Appointed as RCORE for Vaccines Regulatory OversightOn 25 August 2023, the South African Health Products Regulatory Authority (SAHPRA) was appointed as the Regional Centre of Regulatory...
ARQonAug 28, 20231 minAustralia: TGA Add-on Reporting Requirements for Medicines Shortages in AustraliaPrior to the changes of the Therapeutic Goods Act 1989 which was enforced in March 2023, sponsors are required to notify the Therapeutic...