medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The UK based company GenomeKey has a rapid diagnostic test for sepsis is in progress. Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is awarding GenomeKey up to $3 million in non-dilutive funding to develop a rapid diagnostic for sepsis. GenomeKey is…
The Medical Device Coordination Group (MDCG) has published a Q & A on the Medical Devices Regulation (EU) 2017/745/ (MDR) regarding clinical investigation. The document MDCG 2021-6 is entitled ‘Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation’. Who…
CMDh Minutes for the meeting on 23-25 March 2021 The minutes from this meeting are available here. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product The updated list is available here. RMS Validation…
The Medical Device Coordination Group (MDCG) has published MDCG 2018-1 Rev.4 to the guidance on Basic UDI-DI and changes to UDI-DI. A previous post covered the UDI in some detail. The main change of note is the addition of Point…
About PIC/S The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any authority having…
The EMA has published a Q&A on the principles of GMP for the manufacturing of startingmaterials of biological origin used to transfer genetic material for the manufacturing ofAdvance Therapy Medicinal Products (ATMPs). Is a GMP certificate required for manufacturing and…
The HPRA, Ireland has posted the following updates on its website: Regulatory submission query form for human medicines This is a new form and it is available here. Application form to Withdraw an Authorisation Licence Approval or Registration The updated…
Following a consultation in Jan 2021, the EU has adopted the parallel application for EU-M4all (Article 58) opinion and Centralised Marketing Authorisation procedure on 13 April 2021. You can read more about EU-M4All and the consultation here.
The TGA Australia has published three separate updates to guidance on the eligibility criteria for provisional or priority determination of medicines or orphan drug designation. All three updates are minor and concern an update to currency of data required for…
The EU Clinical Trials Information System (CTIS) has reached a major milestone towards go-live and application of the Clinical Trials Regulation. The European Medicine Agency’s Management Board confirmed that the clinical trial EU Portal and Database, one of the main deliverables of the Clinical Trials…