The FDA has updated its COVID-19 Guidance for Conducting Clinical Trials with a new question regarding the Investigator’s responsibilities in the review of IND safety reports. The FDA has also issued a new guidance document to help assess the benefits of potential treatments on COVID-19-related symptoms during clinical trials.
The FDA has published for comments a new draft guidance document, which is intended to assist applicants in determining the appropriate placement and content of geriatric information in product labeling.
The EMA has published for consultation its draft guideline on registry-based studies to promote the use of such studies as a source of real-world evidence. The EMA has also scheduled a virtual workshop on this draft guideline.
The MHRA has announced a series of free webinars to help understand the guidance recently published on the rules that will apply once Brexit becomes fully effective on 01-Jan-2021.
New PV Guidance in South Africa
The South African Health Products Regulatory Authority (SAHPRA) has issued a revised version of the guideline covering Post-Marketing Safety Reporting, which brings changes to ICSR and PSUR reporting requirements.
Hot topics are taken from Safety Observer Lite 171, October 2020
EU Clinical Trials Regulation
The EMA has announced a webinar to demonstrate the current status of the CTIS (Clinical Trials Information System), which is currently planned to go live in December 2021. A revised version of the draft Q&A Document on the new EU Clinical Trials Regulation has also been published. More Information
New FDA Draft Guidance
The MHRA has published new guidance to describe the requirements that will apply for the UK after the transition period ends, i.e. from 01-Jan-2021. The topics covered include Pharmacovigilance Procedures, QPPV and PSMF.
ANVISA, the Medicines Agency in Brazil, has published 2 final documents, which cover Good Pharmacovigilance Practices for MAHs and the submission of PBRERs to ANVISA.
Hot topics are taken from Safety Observer Lite 170, September 2020