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