How to gain access for performing submissions to the MHRA from 1 January 2021

 The following groups will need to take access to MHRA Submissions in order to start submissions from 1 January 2021: All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activitiesAll medicines...

Read More

Marketing Authorization Holders (MAH) should know these 10 things from BREXIT- MHRA Guidance on Pharmacovigilance Procedures

 MHRA has published updated guidance on pharmacovigilance procedures on 01 September 2020 and new rules will be effective from January 2021 (post-Brexit transition period comes to an end this year). 1. General Approach to the operation of pharmacovigilance This document outlines the submission...

Read More

Therapeutic Good Administration (TGA) safety advisory on the increased risk of non-melanoma skin cancers for medicines containing hydrochlorothiazide (HCTZ)

Hydrochlorothiazide (HCTZ) is used to treat high blood pressure (hypertension), generally in combination with other blood pressure-lowering medicines like Angiotensin Receptor Blockers (ARBs), Calcium Channel Blockers, Beta Blockers etc.Recently on 24 August 2020, Australian Health Authority- Therapeutic...

Read More