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Blog - MHRA Inspectorate
MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers
The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.

FDA new COVID-19 Guidance

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.

New FDA Draft Labelling Guidance

The FDA has published for comments a new draft guidance document, which is intended to assist applicants in determining the appropriate placement and content of geriatric information in product labeling.

EMA consults on Registry Studies

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.

MHRA to run free Brexit webinars

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New FDA Draft Guidance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 US FDA has issued new guidance documents on Pregnancy & Lactation Labeling, and on the assessment of Drug-Drug Interactions for Therapeutic Proteins

MHRA Post-Brexit 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.

GPvP in Brazil

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.

CIOMS Guides

CIOMS has published new information regarding the recent consensus report on Drug-Induced Liver Injury (DILI). Additionally, Vaccine Safety Guides are now available for free on the CIOMS website.

Hot topics are taken from Safety Observer Lite 170, September 2020