medicines-medical devices-regulatory affairs
The US FDA has published a detailed Q & A about the end of the compliance and enforcement policy for certain human cells, tissues or cellular or tissue based products (HCT/Ps). As stated in the guidance, Regulatory Considerations for Human Cells,…
There are currently a couple of EU clinical trials related guidelines under consultation. Both guidelines must be considered in connection with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, which came…
An Artificial Intelligence (AI) powered device able to detect SARS-CoV-2 (the virus that causes COVID-19) within 20 seconds is currently under UK MHRA assessment. What is the test called? The device is called SpectraLIT. Who has developed this test? The SpectraLIT device…
The UK MHRA has issued new guidance on authorisations and procedures required to Import Investigational Medicinal Products (IMPs) from countries on a list, to Great Britain (GB). Information is also provided on the importation of authorised/unathorised: non-investigational medicinal products unmodified…
The UK MHRA and Health Canada have collaborated to publish guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs). The guidance will improve the…
Health monitoring and therapy firm OMRON Healthcare has launched OMRON Complete, its first single-lead electrocardiogram (ECG) and blood pressure (BP) monitor for home use. OMRON complete is designed for the detection of atrial fibrillation (AFib). AFib is the most frequently…
The UK MHRA has published its new Delivery Plan 2021-2023. The plan has one overarching goal which is to deliver for patients and the public. The new plan is designed to bring together and prioritise the MHRAs existing efforts in…
The Clinical Trials Information System (CTIS) newsletter Issue 3 of June 2021 has now been published. This issue includes information on the following topics: Key organisation models in CTIS The organisation-centric approach – is used by authority users (EU Member…
Post last updated on 5 July 2021. The TGA, Australia has created a hub on the Unique Device Identification (UDI) system for medical devices. The hub brings together information about the Australian Unique Device Identification (UDI) system under the following…