Ntroduction to EU/UK Pharmaceutical Regulatory Affairs

1. What is regulatory affairs? ensures medicines are safe, effective + comply with regulations 2. Marketing authorisation: process for approving pharmaceutical products for market distribution 3. What is a common technical standard dossier for marketing authorisation document? application 4. What are quality standards? set criteria for medicine manufacturing, distribution and dispensing, ensuring pharmaceutical products meet safety + efficacy requirements 5. What are post approval changes? modifications made to pharmaceutical products after market approval 6. Medicines Act 1968: established regulations for medicines review + approval in the UK 7. Medicines control agency: regulatory body overseeing medicines licensing in the UK 8. Regulatory authorities responsibilities: tasks include licensing, safety assessment, quality control + monitoring 9. MHRA responsibilities: ensuring the safety, effectiveness + quality of medicines in the UK 10. What are EU legislation types? - regulations - directives - decisions = governing EU pharmaceutical regulations 11. What are directives? - addressed to all member states - requires national legislation compliance 12. What are decisions? issued by council / commission; not of general application 1/4 13. What is marketing authorisa- only applicants in the EU eligible for granting tion holder (MAH)? marketing authorisation 14. What are CTD triangle? comprises modules 1-5 detailing administrative, quality + clinical info for pharmaceutical product registration 15. PIL: info for patients on medication usage, part of the CTD triangle 16. Summary of Product Charac- details therapeutic indications, side effects + teristics (SmPC): administration, part of the CTD triangle 17. What is post-authorisation study? may be imposed after MA approval for safety & effiacy 18. Centralised Procedure (CP): allows EU-wide MA for specific drug types 19. National Procedure (NP): marketing authorisation for individual EU member states 20. Mutual recognition procedure procedure for gaining approval in multiple EU (MRP): states after national approval 21. Decentralised Procedure (DCP): simultaneous marketing authorisations in multiple EU states, for new products 22. Good Manufacturing Practices (GMP): guidelines ensuring pharmaceutical product meets quality + safety 23. GMP (good manufacturing practice) Guidelines ensuring drug safety for human consumption 24. Eudralex Volume 4 EU guidelines covering GMP requirements 25. The Orange Guide: UK Medicines Act (1968) covering GMP (good manufacturing practice) 26. GxP: 2/4 good practice systems like GMP for various areas 27. GLP: Good Laboratory Practice for non-clinical studies in labs 28. GCP: Good Clinical Practice for clinical studies on new drugs 29. GRP: Good Regulatory Practice for managing regulatory commitments 30. GDP: Good Distribution Practice for proper medicinal product distribution 31. GTP: (guidelines for) Good Transport Practice for proper product transportation 32. Pharmacovigilance activites: monitoring + assessing drug safety post-market 33. What is medicines regulation? regulatory oversight of drug manufacturing + distribution 34. What is Variations? changes to marketing authorisation 35. Type 1A: minor changes to a product license submitted after implementation 36. Type IAIN: minor changes needing immediate notification 37. Type IB: minor changes requiring approval before implementation 38. Type II: major changes impacting product quality / safety / efficacy 39. Grandfathering of CAP (cen- automatic conversion of EU licenses to UK trally authorised products): 3/4 40. Managing existing MRP/DCP: options for MA Holders post-transition period 41. Creating new MRP/DCPs: procedures for introducing UK authorisations into EU MRP/DCP 42. What is Access Consortium? regulatory collaboration group for timely access to medicines 43. EC Decision Reliance Proce- procedure for MA approved via centralised dure: EUU route 44. Regulation (EC) No 1901/2006: focuses on medicines for children in the pharmaceutical product lifecycle 45. Directive 2001/83/EC: EU legislation applying to all human medicinal products, with exceptions 46. Project Orbis: program for reviewing + approving cancer treatments 4/4