medicines-medical devices-regulatory affairs
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 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…
The FDA has recently updated its information on possible mitigation strategies to reduce the risk of nitrosamine drug-substance related impurities in drug products (NDSRIs). Guidance for industry on nitrosamine was published in September 2020 and updated in February 2021. A…
Hologic has launched its Artificial Intelligence (AI) based Genius Digital Diagnostics system in Europe, for cervical cancer screening. The burden of cervical cancer in Europe According to a study by the EPF in 2020: Current estimates indicate that every year, 61,072…
Health Canada has published an update on Update on the Implementation of ICH’s Q12 Guideline and Pilot Programs. What is the ICH 12 guideline about? The ICH guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” (ICH Q12)…
The FDA CDER Export Certificate Program is being modernised, with a move soon to electronic Certificate of a Pharmaceutical Product (eCPPs). Who are the end users of CPPs? Manufacturers exporting products from the U.S. are often asked by foreign customers…
The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers. The following items are addressed: On-going…
The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation. This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an…