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…)

Draft Guidance on Implementing GDUFA II By FDA

The US FDA revised draft guidance on the generic drug user fee program (GDUFA II) which serves the new fee structure and types of fees will be assessed. (more…)

MHRA Offers Guidance on Comparator products in BE/TE studies after Brexit

MHRA provides No-Deal Brexit Guidance on Comparator Products for Generic Drug Studies. This guidance provides further information on comparator products used in studies supporting abridged marketing authorisation applications in a no-deal Brexit. (more…)