Albania Enters as Member State in European Pharmacopoeia

Albania entered in to the member state of European Pharmacopoeia as 39th member on 9 February 2020, making the quality standards for medicines published in the European Pharmacopoeia (Ph. Eur.) legally binding throughout the country. (more…)

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…)