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...

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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...

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A brief summary from MHRA Pharmacovigilance Inspection Metrics Report: April-2018 - March 2019

During the period 01 April 2018 to 31 March 2019, the MHRA’s Good Pharmacovigilance Practice (GPvP) inspectorate conducted 18 inspections of marketing authorisation holders (MAHs). The MHRA has recently published their...

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PSUR submission summary in the United Kingdom (UK) about a possible no-deal Brexit

Periodic Safety Update Reports (PSURs):-A. PSURs submitted after exit daya. MHRA will continue to accept EU version of PSURsb. MHRA specific request for information needs to be included in specific annexurec. MHRA has developed its own submission requirements and develop a list of...

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Service Level Agreement (SLA) in Pharmacovigilance perspective

Service Level Agreement (SLA) is generally mutual commitment between service provider and a client. In pharmacovigilance industry, pharmacovigilance service provider and pharmaceutical company (client) come together in agreement for various PV activities. This could be single PV activity or End...

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Article 31 -EMA to review ranitidine medicines following detection of NDMA

      Under Article 31 of Directive 2001/80/EC, the review of ranitidine containing medicines was initiated at the request to the European Commission. This review will be carried out by the Committee for Medicinal Products for Human Use (CHMP). The CHMP opinion will then be forwarded...

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Pharmacovigilance Abbreviations / Acronyms

Term Description ADCO Addendum to Clinical Overview ADRs Adverse Drug Reactions AE Adverse Event AERS Adverse Event Reporting System ANDA Abbreviated New Drug Application ATC Anatomical Therapeutic Chemical  (in Anatomical Therapeutic  Chemical ...

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