medicines-medical devices-regulatory affairs
The table below details changes to five guidance documents (listed in column 1 below) for the authorisation of human medicinal products. Updated guidance document Document (plus form where applicable) What the document concerns Changes to the document Sections of the…
Date Title of guidance and link to document Type and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…
Guidance No. About the guidance MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR – December 2023 This guidance is intended to clarify the exemptions from the requirement to perform clinical investigations…
Last updated: 21 December 2023 See updates at the end of the post. The parties involved in the case The parties involved in this case were Pharmaceutical Works Polpharma S.A versus the European Medicines Agency (Case T-611/18) supported by the…
Last updated: 21 December 2023 See updates at the end of the post. Meeting with Interested Parties – 15 November 2023 These meetings appear not to have any minutes published which would be very useful. Instead, the individual presentations from…
This post the following TGA updates on GMP clearance for an overseas manufacturing site: 1. GMP clearance sponsor information dashboard and guidance updates This update concerns sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site…
Last updated: 6 December 2023 See updates at the end of the post. The FDA has partnered with Health Canada to launch a joint eSTAR pilot. What is eSTAR? Electronic Submission Template And Resource or eSTAR is an interactive PDF…
Last updated: 28 November 2023 See updates at the end of the post. In September 2021, the European Medicines Agency (EMA) provided final feedback to the European Commission (EC) on its request to evaluate the impact of the removal of…
Last updated: 28 November 2023 See updates at the end of the post. The European Medicines Agency (EMA) has published technical and procedural guidance on the replacement/removal of titanium dioxide (TiO2) in medicines. You can view it on this page.…
Last updated: 28 March 2025 To view updates click on the ‘+’ sign below: Artificial Intelligence (AI) is slowly but inexorably creeping into our lives in everything that we do. Not a day goes by without new stories in the…
This blog post provides basic information on decentralised clinical trials and links to guidance/resources available in various countries/region(s). What is decentralisation? Clinical trials on Investigational Medicinal Products are increasingly using procedures conducted outside the traditional ‘clinical trial site’, a concept…
Lost updated: 14 November 2023 See updates at the end of this post. List of safety concerns per approved Risk Management Plan (RMP) of active substances per product This list has been updated and you can download the latest version…