medicines-medical devices-regulatory affairs
31 January 2025 The Canada-Switzerland MRA on Medicinal Products: Drug GMP Compliance Certification, Sectoral Annex on GMP has been in force since 2000. The text of the MRA has not yet been revised as this interpretation was possible on the…
This post the following TGA updates on GMP clearance for an overseas manufacturing site: 1. GMP clearance sponsor information dashboard and guidance updates This update concerns sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site…
On 24 May 2022, the European Commission published a notice to stakeholders on the status of the EU-Switzerland mutual recognition agreement (MRA) for IVDs. Accordingly, affected stakeholders (e.g. manufacturers, EU importers and distributors, authorised representatives) are required to act in accordance…