medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
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 27 September 2021 is covered. On mobile, the table is best viewed by scrolling sideways.…
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…
30 November FDA advisory panel only narrowly endorses Merck’s oral Covid treatment pill An FDA advisory panel narrowly endorsed the use of Merck and Ridgeback Biotherapeutics’ oral Covid treatment pill, despite questions about the drug’s effectiveness, safety and whether it would help…
This post covers international regulatory news in brief. It will be updated on an ad hoc basis. For ease of navigation, a tab has now been added for each region (below). Click on the respective tab to view the news…
Title of guidance Type and level of guidance About the guidance Source Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry Nov 2021 Draft, Level 1 guidance The 21st Century Cures Act signed…
Last updated on: 24 November 2021. See update at the end of the post. TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products. What are Therapeutic Good Orders…
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…
CMDh meeting 9 – 11 November report The report from the above meeting is available here. Items of note include the following: 1) Risk of azido-impurity in losartan-containing medicinal products In September 2021 the CMDh published a letter addressed to…
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…
Last updated: 10 November 2021 See section on updates at the end of the post. The importance of Article 117 of the MDR, for Drug-Device Combination (DDC) products should not be underestimated. Anyone in regulatory affairs working on Drug-Device combination…