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”
Category: Regulation
Regulatory news and updates
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”
Regulatory expectations for medicinal products in the context of COVID-19
The European Commission (EC), European Medicines Agency (EMA) and the European medicines regulatory network have developed a question-and-answer (Q&A) document for stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. Read more “Regulatory expectations for medicinal products in the context of COVID-19”
When is a device exempt from a pre-market clinical consultation?
The Medical Device Coordination Group (MDCG) have issued a revised guidance on the criteria exempting medical devices from pre-market clinical evaluation consultations with expert panels. Read more “When is a device exempt from a pre-market clinical consultation?”