Key Contact: Ronan Dunne – Partner | Marie Kinsella – Partner
Welcome to the latest update from the Philip Lee Healthcare, Pharmaceutical and Life Science group in respect of the fourth quarter of 2022.
This update covers a range of topics:
General Regulatory – Ireland
1. Guidance issued by the HPRA on appeals under Cosmetic Products Regulation 2013
General Regulatory – EU
2. European Commission adopts Report on implementation of the Organ Transplantation Directive
3. Common Specifications have been introduced for Devices without an Intended Medical Purpose
4. Regulation on European Centre for disease prevention and control published in Official Journal
5. Regulation on serious cross border threats to health published in the Official Journal
6. Reclassification of Certain devices without an Intended Medical Purpose
7. Proposal to extend Transitional Deadlines for the Medical Devices Regulation and the In Vitro Diagnostic Devices Regulation
8. New European Commission Expert Group on Public Health
9. European Commission Changed Labelling Requirements for Investigational Medicinal Products
10. Publication of European Commission note on the revision of EU pharmaceutical legislation
Global Insights
11. European Health Data Space
12. Novo Nordisk and Microsoft announce collaboration to accelerate drug discovery
13. Report on EU Covid-19 Vaccine Procurement Performance
14. European Commission Work Programme 2023: Life Sciences Initiative
15. Transformation of the General Product Safety Directive 2001
16. Publication of “Health at a Glance: Europe 2022” by the European Commission and the OECD
17. Quality Innovation Expert Group established by EMA
Data Protection
18. Public Consultations launched by the EMA on data quality and real-world data sources
19. Public Consultations launched by the EMA on data quality and real-world data sources
Healthcare
20. EMA publishes ICH guideline E19 on selective safety data collection in specified clinical trials
21. Highlights of fifth bilateral meeting between EMA and Medicines for Europe
22. Positive Opinion issued by the EMA on second adapted Spikevax Vaccine
23. Cominarty and Spikevax vaccines recommended by EMA for children from six months
24. CJEU makes preliminary ruling on M2Beautè
25. Updated guidance on applications for orphan designation published by the European Commission
26. European Commission proposes new EU Global Health Strategy to improve global health security
27. Joint European Commission and World Health Organisation announcement on global health co-operation
28. Council Recommendation on a new EU approach on cancer screening published in Official Journal
To read the full update see: Philip Lee – Healthcare Newsletter Q4 2022.
For further information in relation to this article please contact Ronan Dunne or Marie Kinsella.
