Swissmedic and MFDS-Korea sign an agreement on Mutual Recognition for GMP Inspections

Swissmedic and the Korean regulatory authority extend their cooperation in the area of therapeutic products by recognizing each other for GMP Inspections. (more…)

EU Medical Agencies Defines Key principles for the use of electronic product information (ePI)

The European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and the European Commission (EC) have published Key principles outlining a harmonised approach to develop and use of ePI – electronic product information. (more…)

Guidelines for The Pre-Accession Procedure to Join PIC/S

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has introduced new guideline to The Pre-Accession Procedure to Join PIC/S for competent authorities who interested to join the inspection program. (more…)

Draft Policy on Designating Regulators as Listed Authorities (WHO-Listed Authority) by WHO

The World Health Organization’s vision towards strengthening the regulation of medical products in underserved regions, the WHO published a draft policy on Designating Regulators as Listed Authorities (WHO-Listed Authority) to establish a framework for ensuring certain medical product regulators can be globally recognized as meeting WHO and other international standards and practices. (more…)

TGA List Out Comparable Overseas Bodies (COBs) For Complementary Medicines

The TGA makes use of assessments from comparable overseas bodies (COBs), where possible, in evaluations for complementary medicines and listed OTC medicines. COBs in the European Union and US are among the organizations to have met the criteria established by TGA. (more…)