The International Council for Harmonisation (ICH) have released a draft version of their guideline E8(R1) on the general considerations for clinical trials, which is open for public consultation. Read more “ICH opens public consultation on their drafted revised guideline E8(R1) on the general considerations for clinical trials”
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European Commission releases information on what UDI information to provide for Eudamed as part of the MDR and IVDR
The European Commission have released three guidance documents, which include two on the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) and the data from the unique device identifier (UDI) which needs to be included in the Eudamed database of devices and IVDs. The third document concerns the Eudamed device data dictionary. Read more “European Commission releases information on what UDI information to provide for Eudamed as part of the MDR and IVDR”
Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for GMP inspections
Bulgaria and Cyprus have been added to the mutual recognition agreement for good manufacturing practice (GMP) inspections between the United States (US) Food and Drug Administration (FDA) and the European Union (EU) member states. The FDA can now recognise inspections carried out by regulators from Bulgaria and Cyprus. Read more “Bulgaria and Cyprus to benefit from EU-US mutual recognition agreement for GMP inspections”
Highlights from the April CHMP meeting
From their meeting in April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting the CHMP announced recommendations for thirteen medicines for approval. Read more “Highlights from the April CHMP meeting”
FDA further delays compliance date for postmarketing safety reporting requirements for combination products
After pushing back the date by which combination product companies must comply with certain postmarketing safety reporting (PMSR) requirements, the United States (US) Food and Drug Administration (FDA) have further delayed the compliance deadline by a year. Read more “FDA further delays compliance date for postmarketing safety reporting requirements for combination products”
MHRA updates its “final determinations on borderline products”
MHRA has published an updated list of final determinations issued by the Borderline division within the agency. Details of the product names, the names of the companies to whom the determination notices were issued and brief details of the reasons for the determination are provided. Read more “MHRA updates its “final determinations on borderline products””
European Commission outlines the data protection requirements of the incoming Clinical Trials Regulation and how it interacts with GDPR
The European Commission have released a document which outlines the interplay between the clinical trial rules and the General Data Protection Regulation (GDPR). The guidance describes the data protection requirements of the new incoming Clinical Trials Regulation (CTR) and how the regulation relates to GDPR. The question and answer (Q&A) document will only be relevant when the CTR is implemented, however question 11 details the current situation under the Clinical Trials Directive. Read more “European Commission outlines the data protection requirements of the incoming Clinical Trials Regulation and how it interacts with GDPR”
EU Medical Device Coordination Group releases Eudamed guidance
The European Union (EU) Medical Device Coordination Group (MDCG) have released two new documents outlining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies have until November 2021 to register device data elements in Eudamed. Read more “EU Medical Device Coordination Group releases Eudamed guidance”
FDA starts taking steps towards a new, tailored regulatory framework for artificial intelligence-based medical devices
The Food and Drug Administration (FDA) have released a discussion paper on their proposed regulatory framework for artificial intelligence-based medical devices. The FDA consultation is open until 3rd June 2019. Read more “FDA starts taking steps towards a new, tailored regulatory framework for artificial intelligence-based medical devices”
Swissmedic updates guidance on orphan drugs and paediatric investigation plans
The Swiss Agency for Therapeutic Products (Swissmedic) has updated their guidance on orphan drugs and paediatric investigation plans (PIPs). Topics addressed include orphan drug fees and the documentation companies need to supply to support European and American PIPs. Read more “Swissmedic updates guidance on orphan drugs and paediatric investigation plans”