medicines-medical devices-regulatory affairs
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and levelof guidance About the guidance 28 Dec 2023 Potency Assurance for Cellular and Gene Therapy Products Draft This draft guidance provides recommendations for developing a science- and risk-based strategy to…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…
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…
On 16 November 2023, the UK MHRA MHRA authorised the world-first gene therapy based on the innovative gene-editing tool CRISPR. This post is an attempt to provide brief information on the product and the CRISPR-Cas9 system. What is the name…
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…