Pharmacovigilance During Pre-Approval Phases -Comparison of ICH E2E, CIOMS VI, FDA, EMEA/CHMP and CDSCO Risk Management Guidelines
Keywords:Pharmacovigilance risk management, Pre-marketing Pharmacovigilance, FDA, CDSCO, ICH E2E.
To compare Pharmacovigilance planning ICH-E2E, managing safety information from clinical trials (CIOMS-VI), FDA, EMEA/CHMP) and CDSCO risk management guidelines involved in Pharmacovigilance during the pre-approval phases and to find out the differences and similarities between the guidelines (Safety parameters). Systematic search was conducted using different search engines such as Google, Pub med, Web MD, Cochrane, Medline and PLOS-ONE to identify and download the various regulatory guidelines. Safety parameters assessed across regulatory body guidelines were selected for comparison. The similarities and differences between safety parameters of the said regulatory bodies were presented in appropriate manner and opinion was provided on drug safety implications. CIOMS’s Serious Adverse Event (SAE) reporting form is known as Universal SAE reporting form. The purpose of Investigational new drug annual report (IND AR) of FDA is to submit the progress report while that of annual safety report (ASR) of EMEA is to provide a benefit-risk evaluation for the clinical trial concerned. ICH has produced harmonized toxicity guidelines and same have been implemented by FDA and EMEA. Various forms and guidelines required for reporting safety parameters during preapproval phases are harmonized. Animal toxicity studies required by CDSCO are longer in duration when compared to FDA and EMEA.
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