The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA). Read more “What is KASA and how will it affect you? FDA explains plans for the new pharmaceutical quality assessment system.”
Category: Regulation
European Commission releases safety and performance requirements for reprocessing single-use medical devices under the MDR
The European Commission (EC) has outlined the common specifications for the reprocessing of single-use medical devices under the European Union’s (EU’s) medical device regulation (MDR). The common specifications have been issued via a draft implementing regulation in alignment with criteria in Article 17(3) of the MDR. Read more “European Commission releases safety and performance requirements for reprocessing single-use medical devices under the MDR”
European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation
In order to help medicine manufacturers comply with the 2015 European Union (EU) delegated regulation protecting against falsified medicines, which came into force in February 2019, the European Commission has released an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers. Read more “European Commission releases aide-memoire to help medicine manufacturers comply with GMP inspections related to falsified medicines delegated regulation”
UK clinical trial pilot helps companies prepare for the new EU Clinical Trial Regulation
To prepare for the future of clinical trials under the European Union (EU) Clinical Trial Regulation 536/2014, the United Kingdom (UK) has been running a pilot program which aims to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). Read more “UK clinical trial pilot helps companies prepare for the new EU Clinical Trial Regulation”
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”
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”
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”
EMA publishes first series of EU MDR/IVDR guidance
The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR. Read more “EMA publishes first series of EU MDR/IVDR guidance”
European Union advances towards adopting SPC waiver proposal
The European Union (EU) is adopting new rules which aim to increase the competitiveness of EU producers of generic medicines and biosimilar products. The EU’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) advances after EU ambassadors approved a compromise that was reached on 14th February with the European Parliament during a meeting of the Committee of the Permanent Representatives. Read more “European Union advances towards adopting SPC waiver proposal”