Regulatory Blog

Singapore HSA: Safety Alert for Finasteride and Potential Risk of Suicidal iIdeation

EMA Guidance: For Applicants/MAHs involved in GMP and GCP Inspections

Health Canada Recommendations: ICH Q3D(R2) Guideline for Elemental Impurities

SFDA Guide to Good Manufacturing Practice for Medicinal Products

ICH Guidances: Q2(R2) Validation of Analytical Procedures, Q14, M12, E11A, E14 & S7B Updation

SFDA: Guidelines for Stability Testing of API and Finished Pharmaceutical Products

EMA: Updated EudraVigilance Registration Manual

Gilead: First Regulatory Approval of HIV Sunlenca® (Lenacapavir) the Only Twice-Yearly HIV Treatment

USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers

Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

USFDA's Guidance on Hearing Aid Devices, Replacement Reagent & Contact Lens Care Products

UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)

Europe's EDQM: Nitrosamines – Deadline Extension for all CEP Holders - Now 1 October 2023

UK MHRA Guidance on: Manage your authorisation & Report Safety Issues

Colombia's Invima and USP: Memorandum to Strenghthen the Quality of Medicine

USFDA's New WebPage: For Complex Generics

Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes

UK MHRA Guidance: Medicines: How to Reclassify your Product

Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products

USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies