In Brexit Transition UK MHRA Escape as ‘Leading Authority’ for Drugs

UK MHRA will not act as ‘leading authority’ for medicines during the Brexit transaction period as per Article 123 of the draft Withdrawal Agreement. In which UK MHRA will not act as leading authority for risk assessments, examinations, approvals and authorisations at the level of the Union or of Member States. (more…)

Implementation of Clinical Trials Regulatory Activities in eCTD Format Begins by Health Canada

After successful Clinical Trial regulatory activities in electronic Common Technical Document (eCTD) format in the pilot in August 2019, Health Canada begins implementation of Clinical Trials regulatory activities in eCTD format. (more…)

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…)

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…)