Research ArticleResearch
Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1
Cynthia Ban
1Sanofi, Global Regulatory CMC, Toronto, Canada;
Jamie Graham
1Sanofi, Global Regulatory CMC, Toronto, Canada;
Lyne Le Palaire
2Sanofi, Global Regulatory Affairs & Quality, Lyon, France;
Priya Persaud
1Sanofi, Global Regulatory CMC, Toronto, Canada;
Franziska Brehme
3Sanofi, Regulatory Affairs, Berlin, Germany; and
Olivier Faure
2Sanofi, Global Regulatory Affairs & Quality, Lyon, France;
Allison Rameau
2Sanofi, Global Regulatory Affairs & Quality, Lyon, France;
Ana Luisa Silva
4Sanofi, Regulatory Affairs, Sao Paulo, Brazil

References
- 1.↵
- Dellepiane N.,
- Pagliusi S.,
- Akut P.,
- Comellas S.,
- De Clercq N.,
- Ghadge S.,
- Gastineau T.,
- McGoldrick M.,
- Nurnaeni I.,
- Scheppler L.
- 2.↵
- Zerhouni E.,
- Hamburg M.
- 3.↵
- Hoath C.,
- Chang L.,
- Iyer K. R.,
- Kutza J.,
- Murray S.,
- Smith H.,
- Payne R.
- 4.↵
- O’Brien J.,
- Lumsden R. S.,
- Diehl D. H.,
- Macdonald J. C.
- 5.↵
- Rodriguez H.,
- De Lucia M. L.
- 6.↵
- 7.↵World Health Organization. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: With an Updated List of Participating Countries, Rev. 5. World Health Organization, 1997. https://apps.who.int/iris/handle/10665/63547 (accessed February 15, 2024).
- 8.↵The Complex Journey of a Vaccine – Part II: Immunization Supply Chain, Delivery Innovation, and Regulatory Requirements; IFPMA, 2016. https://ifpma.org/wp-content/uploads/2023/01/i2023_IFPMA-ComplexJourney-Part_Two_2016.pdf (accessed May 6, 2024).
- 9.↵
- Gastineau T.,
- Ban C.,
- Basso A.,
- Brehme F.,
- Silva A. L.,
- Faure O.,
- Le Palaire L.,
- Persaud P.,
- Rodriguez H.
- 10.↵World Health Organization. WHO-Listed Authority (WLA). https://www.who.int/initiatives/who-listed-authority-reg-authorities (accessed July 19, 2024).
- 11.↵WHO Expert Committee on Specifications for Pharmaceutical Preparations. Annex 10: Good Reliance Practices in the Regulation of Medical Products: High Level Principles and Considerations; WHO Technical Report Series No.1033; WHO, 2021.
- 12.↵WHO Expert Committee on Biological Standardization. Annex 4: Guidelines on Procedures and Data Requirements for Changes to Approved Vaccines; WHO Technical Report Series No.993; WHO, 2015.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 79, Issue 3
May/June 2025
Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau, Ana Luisa Silva
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: 10.5731/pdajpst.2024-003023.1
Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau, Ana Luisa Silva
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: 10.5731/pdajpst.2024-003023.1
Jump to section
Related Articles
- No related articles found.
Cited By...
- No citing articles found.