medicines-medical devices-regulatory affairs
Last updated: 1 February 2024 See updates at the end of the post. Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Here, you can view the track changed (September 2023) and clean…
Last updated: 31 January 2024 See updates at the end of the post. Report and minutes from the CMDh meeting held on 12-14 December 2023 The reports from the CMDh meetings (also called press releases) reflect highlights/important outcomes of each…
In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in a number of medicinal products, including antihypertensives in the sartans class. Trace amounts of nitrosamine impurities were also subsequently detected in other medicinal products.Swissmedic evaluates and oversees…
This post concerns a recent court case in which an EU Supplementary Protection Certificate manufacturing waiver was put to the test in a Munich court. About Supplementary Protection Certificate (SPC) manufacturing waivers With the entry into force of Regulation (EU) 2019/933 on…
This post is an attempt to present some of the salient information from Case C-473/22 concerning Mylan vs Gilead on potential Supplementary Protection Certificate (SPC) infringement. The information provided below is by no means exhaustive. In order to develop a…
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…
The UK MHRA has developed a process to share operational information with health system partners across the UK. This applies to medicines applications submitted via National and International Recognition regulatory routes. For the purposes of operational information sharing, what is…
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and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…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…