The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance covering the licensing of biological medicinal products (biosimilars) in the United Kingdom (UK). Read more “Licensing of biosimilars in the UK”
News
Latest HPRA Medical Devices newsletter provides key updates on MDR and IVDR
Ireland’s Health Products Regulatory Authority (HPRA) has released issue 53 of its Medical Devices newsletter which is focussed on preparing manufacturers for the European Union (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read more “Latest HPRA Medical Devices newsletter provides key updates on MDR and IVDR”
Updated PIC/S GMP guide for ATMPs and biological substances
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published revisions to its good manufacturing practice (GMP) guide for advanced therapy medicinal products (ATMPs) and biological medicinal substances. Read more “Updated PIC/S GMP guide for ATMPs and biological substances”
Class I medical devices factsheet
A factsheet for manufacturers released by the European Commission (EC) outlines the regulation of Class I medical devices following the implementation of the European Union (EU) Medical Device Regulation (MDR). Read more “Class I medical devices factsheet”
Updated MDCG guidance on UDI-DI
The implementation of the European Union (EU) Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) sees the introduction of a Unique Device Identification (UDI) system for medical devices. A UDI guidance document from the Medical Device Coordination Group (MDCG) has recently been updated with a new section covering devices with a maximum number of reuses. Read more “Updated MDCG guidance on UDI-DI”
EMA guidance on the application of GMP to ATMP starting materials
The European Medicines Agency (EMA) has recently issued a Q&A guidance document detailing how the principles of good manufacturing practice (GMP) should be applied to the manufacture of starting materials of biological origin for advanced therapy medicinal products (ATMPs). Read more “EMA guidance on the application of GMP to ATMP starting materials”
FDA removes certain software functions from device classifications
The US Food and Drug Administration (FDA) has published a ruling in the Federal Register removing certain software functions from its device classification regulations. Published on April 19 2021, the ruling is effective immediately from this date. Read more “FDA removes certain software functions from device classifications”
MDCG releases Q&A for sponsors of clinical investigations of medical devices
A Q&A document for sponsors of clinical investigations of medical devices under the European Union (EU) Medical Device Regulation (MDR) has been released by the Medical Device Coordination Group (MDCG). Read more “MDCG releases Q&A for sponsors of clinical investigations of medical devices”
CTIS declared fully functional
The European Medicines Agency (EMA) has confirmed that the European Union (EU) clinical trial portal and database are fully functional. This sets the stage for the launch of the EU Clinical Trial Information System (CTIS) and the resultant application of the EU Clinical Trial Regulation from 31 January 2022. Read more “CTIS declared fully functional”
Extended licencing of implantable devices and imaging equipment in India
India’s Central Drugs Standard Control Organisation (CDSCO) has released a notice concerning the regulation of certain medical devices. Read more “Extended licencing of implantable devices and imaging equipment in India”