The Association of the British Pharmaceutical Industry (ABPI) and the British Healthcare Business Intelligence Association (BHBIA) have produced a revised version of their guidance on collecting adverse events, product complaints and special situation reports during market research programmes (MRPs). The guidance document was first issued in October 2009, and is now version 4, which took effect from the beginning of October 2018. Read more “ABPI revises guidance for Pharmacovigilance in Market Research”
Category: PV
EMA finalises guideline on GVP considerations for paediatric populations
The European Medicines Agency (EMA) has finalised their recently adopted guideline on good pharmacovigilance practices (GVP) module which provides recommendations for pharmacovigilance in paediatric populations. Read more “EMA finalises guideline on GVP considerations for paediatric populations”
TGA opens consultation on use of boxed warnings to highlight safety issues
The Therapeutic Goods Administration (TGA) Australia has opened a consultation on guidance regarding the use of boxed warnings used to highlight serious safety issues. The guidance outlines the objectives for introducing a boxed warning to a Product Information (PI) document, and provides advice on how and when to use a boxed warning. The aim is to ensure consistency across the prescription medicines regulatory framework. Read more “TGA opens consultation on use of boxed warnings to highlight safety issues”
EMA clarifies MAH obligations to record adverse events accessed through EudraVigilance
The European Medicines Agency (EMA) has published a note which clarifies the pharmacovigilance obligations of marketing authorisation holders (MAHs). The note provides information about when MAHs must record information regarding adverse events they access via EudraVigilance. Read more “EMA clarifies MAH obligations to record adverse events accessed through EudraVigilance”
MHRA releases guidance for submission of educational material
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued guidance on how marketing authorisation holders (MAHs) should provide educational materials to the MHRA for assessment and approval prior to launching their products on the United Kingdom (UK) market. Read more “MHRA releases guidance for submission of educational material”
EMA publishes updated Q&A from stakeholders on the launch of the new EudraVigilance system
The European Medicines Agency (EMA) has published an updated question and answer (Q&A) document from stakeholders on the launch of the new EudraVigilance system. The document addresses questions that were received from stakeholders as part of the launch of the new EudraVigilance system, which went live on 22nd November 2017. Read more “EMA publishes updated Q&A from stakeholders on the launch of the new EudraVigilance system”
FDA delays PMSR requirements for combination products
The US Food and Drug Administration (FDA) have delayed the enforcement of post-market safety reporting (PMSR) requirements for combination product manufacturers, which gives affected registrants more time to ensure compliance. Read more “FDA delays PMSR requirements for combination products”
Operation of EudraVigilance and release of 5.0
On 14th February 2018, EudraVigilance release 5.0 was launched in accordance with the EudraVigilance Auditable Requirements project plan, and as announced prior to the go-live of the new and enhanced EudraVigilance system on 22nd November 2017. Read more “Operation of EudraVigilance and release of 5.0”
TGA surveys sponsors to prioritise Pharmacovigilance inspections
The Therapeutic Goods Administration (TGA) Australia has released a Pharmacovigilance Inspection Program (PVIP) risk assessment survey for sponsors to complete. The TGA is surveying sponsors about their Pharmacovigilance (PV) activities to identify high-priority targets for its new inspection program. Read more “TGA surveys sponsors to prioritise Pharmacovigilance inspections”
MHRA GPvP Inspectorate Guide to MAH considerations for agreements with Pharmacovigilance system service providers
The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate has released guidance to Marketing Authorisation Holders (MAHs) with regards to considerations for agreements with Pharmacovigilance (PV) system service providers. Read more “MHRA GPvP Inspectorate Guide to MAH considerations for agreements with Pharmacovigilance system service providers”