Ireland’s Health Products Regulatory Authority (HPRA) has updated two guidances, on good distribution practices (GDP) and wholesaling of medicinal products for human use. Read more “Ireland’s HPRA revise two guidances”
Category: Regulation
Regulatory news and updates
The impact of the orphan and paediatric regulations
The European Commission (EC) has published results from an evaluation of the EU orphan and paediatric regulations. Read more “The impact of the orphan and paediatric regulations”
European Commission proposes relaxation of GMO regulations
The proposal to relax regulation of genetically modified organisms (GMO) would allow GMO-containing COVID-19 candidate vaccines and therapeutics to proceed with clinical trials. Read more “European Commission proposes relaxation of GMO regulations”
FDA releases policy for ANDA conversion after patent infringement
What is the US Food and Drug Administration (FDA) procedure for the conversion of an abbreviated new drug application (ANDA) status from final to tentative approval, following a court order for patent infringement? Read more “FDA releases policy for ANDA conversion after patent infringement”
Transitioning devices with ancillary substances to MDR
A guidance recently published by the Medical Device Coordination Group (MDCG) explains the process for transitioning CE certificates for devices containing an ancillary substance under the Medical Device Regulation (MDR). Read more “Transitioning devices with ancillary substances to MDR”
The latest update on the MDR, IVDR implementation timeline
The European Commission (EC) has updated its rolling plan for adopting implementing acts ahead of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Read more “The latest update on the MDR, IVDR implementation timeline”
EMA update pre- and post-authorisation procedural advice for centralised procedures
Below is a summary of the updated Q&A documents released by the European Medicines Agency (EMA) for users of the centralised procedure. Read more “EMA update pre- and post-authorisation procedural advice for centralised procedures”
EMA checklist for initial notifications for parallel distribution
The European Medicines Agency (EMA) has released guidance for industry with a checklist for use in advance of submission of initial notifications for parallel distribution. Read more “EMA checklist for initial notifications for parallel distribution”
The potential impact of COVID-19 on MRP and DCP applications
The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has released a question and answer guidance outlining how regulatory flexibilities will affect these application procedures due to the pandemic. Read more “The potential impact of COVID-19 on MRP and DCP applications”
MDCG publishes five new guidances
The European Commission’s (EC) Medical Device Coordination group (MDCG) has posted five new guidances on clinical evidence for legacy devices, regulatory requirements for ventilators, post-market clinical follow-up (PMCF) plan and evaluation report templates, and clinical evaluation of equivalence to existing devices. Read more “MDCG publishes five new guidances”