medicines-medical devices-regulatory affairs
The TGA has published new guidance entitled Good Clinical Practice (GCP) inspection program – Guidance for GCP inspection of clinical trial sites for investigational biologicals and medicinal products Clinical trials of medicines and biologicals regulated under the Clinical Trial Notification…
The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 24 September 2021 – 13 April 2022 is covered. On mobile, the table is best viewed by scrolling sideways.…
Title of guidance Type and level of guidance About the guidance Source Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft guidance This guidance: • is intended to assist applicants and holders of an abbreviated new…
Last updated: 28 Sebruary 2022 See updates at the end of the post. The UK MHRA has recently published the Target Development Profile (TDP) Toolkit to accompany the Innovative Licensing and Access Pathway (ILAP) licensing route available since the beginning…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnosticmedical devices (IVDs) This document outlines the general principles of clinical evidence…
Last updated: 16 August 2023 See updates at the end of the post. The MHRA has launched a consultation on the UK clinical trials legislation. It is consulting on a set of far-reaching proposals to improve and strengthen the UK…
The European Directorate for the Quality of Medicines & HealthCare EDQM is working on a project to modernise the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP). About CEPs The manufacturer of a substance will be able…
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number About the guidance MDCG 2021-28 Substantial modification of clinical investigation under Medical Device RegulationIn the absence of the European database on medical devices (EUDAMED), a series of…
The European Commission has published a comprehensive study report on medicines shortages in the EU. A very brief overview of the study is available here. About medicines shortages in the EU Medicine shortages present a growing problem for many EU/EEA…
The European Parliament has adopted a report calling for increased use of off-patent medicines in Europe to improve patient access, highlighting lessons learned during the Covid-19 pandemic and urging the European institutions to address them directly in future healthcare policy…
The TGA, Australia has updated several updated guidance documents on aspects of Australian manufacturing licences and overseas GMP certification. 1) Applying for a manufacturing licence for an Australian manufacturing site This updated step-by-step, 47 page guide (version 2.2, Dec 2021) with…