The TGA has published answers to FAQ’s relating to the pharmacovigilance obligations of sponsors of medicines on the ARTG. The aim is to support understanding of the pharmacovigilance responsibilities of medicine sponsors. The following topics are covered in the FAQ: Collecting and reporting adverse drug reactions. Post-registration studies and post-marketing …
On 30-October-2020, EMA had released detailed guidance on ICSRs in the context of COVID 19 – validity and coding of ICSRs. This detailed guidance document provides recommendations relevant to the processing and submission of Individual Case Safety Reports (ICSRs) associated with medicinal products used for the treatment or prevention of …
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements for submission of pharmacovigilance data at the end of the Brexit Transition period, as well as guidance on the qualified person responsible for pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF). Summary …
The FDA has retired its MedWatch to Manufacturer Program as of July 31, 2020, in favor of the FDA Adverse Event Reporting System (FAERS). Created in 1993, the program had allowed participating drug and biologic manufacturers to receive information from the FDA on serious adverse event reports submitted directly to …
A new guidance finalised by the US Food and Drug Administration (FDA) outlines the framework for electronic submissions for medical devices. The guidance clarifies submissions which can be made electronically: Premarket notifications (501k) Evaluation of automatic class III designation request (De Novos) submissions (513(f)(2)) Premarket approval applications (PMAs) including transitional …
Medicines regulatory authorities from around the world have published a report on Thursday highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The report describes the regulatory positions agreed by the meeting participants on …
As the medical and scientific community work tirelessly to find suitable treatments for COVID-19, pharmacovigilance research is essential to understanding the safety and efficacy of treatment alternatives. To collect sufficient information about the efficacy and adverse drug reactions of treatments used against COVID-19, it’s crucial that all adverse events are …
Reporting of adverse events is a mainstay of pharmacovigilance, and an ongoing challenge for the field is how to ensure more reports of higher quality to provide more comprehensive information. A simple app is now being deployed by Uppsala Monitoring Centre (UMC), internationally to boost both the quantity and quality …
Recently EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). This statement is intended for all stakeholders, patients, investigators, researchers, academia, regulators, and the pharmaceutical industry. Refer below link to read Statement issued by ICMRA: http://icmra.info/drupal/news/statement_on_clinical_trials Medicines …
