Latest report November 2022
ICH E19 Guideline on optimization of Safety Data Collection finalised and subsequently adopted by EMA for Europe.
ICH has announced that the ICH E19 Guideline on optimization of Safety Data Collection has now been finalised and the EMA subsequently adopted the guideline for Europe.
Further to the introduction of the combined review process, the British HRA has updated its Safety Reporting guidance for Clinical Trials conducted in the UK.
The FDA has published a new draft guidance to address the processing of Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.
TransCelerate has published new material resulting from its Pharmacovigilance Agreements Optimization (PVAO) Initiative.
Several authorities have published information related to Pharmacovigilance Inspections. This includes a new Risk Assessment Survey that companies should submit to the Australian TGA.
The FDA has published the final guidance entitled “Submitting Documents Using Real-World Data (RWD) and Real-World Evidence (RWE) to FDA for Drugs and Biological Products”.
The EMA has published for consultation a Good Practice Guide for the use of the catalogue of data sources that will replace the currently available ENCePP catalogue.
The Tanzania Medicines and Medical Devices Authority (TMDA) has published instructions for the required notification regarding the Qualified Person for PharmacoVigilance (QPPV).
In the latest “Drug Safety Matters” podcast episode, the Uppsala Monitoring Centre (UMC) explores the advantages and challenges of Identification of Medicinal Products (IDMP) standards.
CIOMS has published Version 2.0 of its Cumulative Glossary with a focus on Pharmacovigilance.
CIOMS has announced the publication of its latest report on “Patient involvement in the development, regulation and safe use of medicines”. The topics covered include Safety Communication, Additional Risk Minimisation, etc.
The ICH M12 draft Guideline on Drug Interaction Studies has entered the consultation period and multiple authorities are now calling for comments, including the US FDA and the EMA.
The FDA has published a new draft guidance for comments, which covers “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies”. Once FAERS enhancements are activated, generic sponsors will be able to transmit these reports in E2B format.
The MHRA has announced that the eSUSAR website will be decommissioned on 30-Sep-2022. Subsequently, SUSARs will only be accepted via the ICSR Submissions portal.
The Drug Regulatory Authority of Pakistan (DRAP) has published for consultation the draft of the 2nd Edition of National Pharmacovigilance Guidelines.
The EMA recently hosted a workshop to discuss the pathophysiology of thrombosis with thrombocytopenia syndrome (TTS), which has been associated with adenovirus-based COVID-19 vaccines.
The EMA has published a list of metadata describing real-world data sources and studies in a move intended to help researchers identify and use this information.
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) has issued the tenth revision of its guide on methodological standards in Pharmacoepidemiology.
The Australian Therapeutic Goods Administration (TGA) has announced the launch of a Beta version of the Database of Adverse Event Notifications (DAEN).