medicines-medical devices-regulatory affairs
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 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 8 May 2020 – 23 September 2021 is covered. On mobile, the table is best…
Last updated: 4 October 2022 See updates at the end of the post. Swissmedic has provided practical interpretation on the requirement of an authorised representative (CH-REP) for drug-device combination products. Swiss authorised representative (CH-REP) The revision of the Medical Devices…
The UK MHRA is seeking views on innovative medicines manufacture at point of care. It has launched a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing. What is POC manufacturing? POC manufacturing refers to the manufacture…
Health Canada is consulting on revised guidance of Post-Notice of Compliance (NOC) Changes – Quality. Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality have been released for stakeholder consultation. Who is the focus of the consultation?…
Last updated: 2 October 2024 See update at the end of the post. The European Medicines Agency (EMA) issued a draft guideline in August for comments, on core Summary of Products Characteristics (SmPC), labelling and package Leaflet for ATMPs containing…
The European Medicines Agency (EMA) has adopted a guideline on quality documentation for medicinal products when used with a medical device. The guideline was adopted on 22 July 2021 and will come into effect on 1 January 2022. What is…