|
Updated: IPEC Position Paper on Role of Excipients in Determining N-Nitrosamine Risks for Drug Products
|
|
3
|
1263
|
March 7, 2024
|
|
New ICH Guideline Q14
|
|
0
|
517
|
February 12, 2024
|
|
Nitrosamine requirements for probiotics
|
|
4
|
372
|
February 12, 2024
|
|
Top 10 deficiencies observed in new CEP applications for chemical purity assessed in 2023
|
|
1
|
657
|
February 9, 2024
|
|
Notifying FDA of a Discontinuance or Interruption in Manufacturing
|
|
0
|
273
|
February 7, 2024
|
|
🇪🇺 EMA/409815/2020 Rev.20
|
|
7
|
5796
|
January 31, 2024
|
|
Sixth Nitrosamine Implementation Oversight Group (NIOG) - meeting with pharmaceutical industry
|
|
4
|
666
|
January 30, 2024
|
|
🇬🇧 Medicines: MAH' submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing
|
|
2
|
1088
|
January 23, 2024
|
|
European Pharmacopeia - Open for comments 'N-Nitrosamines in active substance and medicinal products'
|
|
0
|
714
|
December 19, 2023
|
|
Health Canada updates guidance(incorrect post)
|
|
2
|
507
|
January 14, 2024
|
|
EDQM - European Pharmacopeia - Feedback Nitrosamines
|
|
3
|
1117
|
January 12, 2024
|
|
N Nitroso Vildagliptin amide
|
|
4
|
1500
|
December 18, 2023
|
|
🇰🇷 Korea Drug Review Briefing session on Nitrosamines
|
|
0
|
518
|
December 12, 2023
|
|
NDSRI/ Guidance
|
|
2
|
486
|
December 12, 2023
|
|
Deadline for reporting changes
|
|
2
|
507
|
December 5, 2023
|
|
EMA Q&A Appendix 1 update posted Sept 28,2023
|
|
13
|
1943
|
November 22, 2023
|
|
🇨🇭 Swiss Medic Guidelines
|
|
7
|
1750
|
November 20, 2023
|
|
🇪🇺 EMA - Enhanced AMES test conditions
|
|
0
|
823
|
November 15, 2023
|
|
EMA Q&A Rev. 19 (EMA/409815/2020 Rev.19)
|
|
0
|
1766
|
November 13, 2023
|
|
Revised guidance for J-CTN
|
|
3
|
427
|
November 9, 2023
|
|
Nitrosamine Guidance for Cream and Ophthalmic Solutions
|
|
4
|
783
|
November 3, 2023
|
|
🇦🇺 Australia / Nitrosamine impurities in medicines updates
|
|
0
|
750
|
November 2, 2023
|
|
Review of nitrosamine drug substance related impurities (ndsri) in pharmaceutical drugs
|
|
1
|
767
|
October 31, 2023
|
|
🇨🇦 Health Canada Nitrosamine Guide update
|
|
5
|
2228
|
October 27, 2023
|
|
Investigation of experiences in handling N-nitrosamine impurities among ZaZiBoNa participating countries -Pub
|
|
0
|
532
|
October 16, 2023
|
|
🇨🇦 Health Canada extended deadline?
|
|
4
|
777
|
October 23, 2023
|
|
Reflections on the Impact of Nitrosamine Drug Substance Related Impurities
|
|
0
|
505
|
October 20, 2023
|
|
CPCA is now included in the updated version of Health Canada’s Guidance on nitrosamine impurities
|
|
15
|
2694
|
October 13, 2023
|
|
🇪🇺 EMA Q&A Rev. 18 EMA/409815/2020 - Deadlines
|
|
2
|
1391
|
October 3, 2023
|
|
🇺🇸 FDA - Recommended Acceptable Intake Limits for NDSRIs Guidance for Industry
|
|
47
|
7651
|
September 20, 2023
|