Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine

Thierry Gastineau; Cynthia Ban; Ana Basso; Franziska Brehme; Ana Luisa Silva; Olivier Faure; Lyne Le Palaire; Priya Persaud; Heraclio Rodriguez

doi:10.5731/pdajpst.2023.012850

References

1.↵
1. Dellepiane N.,
2. Pagliusi S.,
3. Akut P.,
4. Comellas S.,
5. De Clercq N.,
6. Ghadge S.,
7. Gastineau T.,
8. McGoldrick M.,
9. Nurnaeni I.,
10. Scheppler L.
Alignment in Post-Approval Changes (PAC) Guidelines in Emerging Countries May Increase Timely Access to Vaccines: An Illustrative Assessment by Manufacturers. Vaccine: X 2020, 6, 100075.
OpenUrl
2.↵
1. Zerhouni E.,
2. Hamburg M.
The Need for Global Regulatory Harmonization: A Public Health Imperative. Sci. Transl. Med. 2016, 8 (338), 338ed6.
OpenUrl FREE Full Text
3.↵
1. Hoath C.,
2. Chang L.,
3. Iyer K. R.,
4. Kutza J.,
5. Murray S.,
6. Smith H.,
7. Payne R.
Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture; Regulatory Complexity and Impact. BioProcess Int 2016, 14, 38–43.
OpenUrl
4.↵
1. O’Brien J.,
2. Lumsden R. S.,
3. Diehl D. H.,
4. Macdonald J. C.
Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally. Ther. Innov. Regul. Sci. 2020, 54 (2), 283–292.
OpenUrl
5.↵
1. Rodriguez H.,
2. De Lucia M. L.
A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-Approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines. Front. Med. 2021, 8, 768376.
OpenUrl
6.↵
1. Gastineau T.
What Can Vaccines Learn from Aviation? Vaccine 2020, 38 (33), 5082–5084.
OpenUrl
7.↵
World Health Organization, Division of Drug Management and Policies. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: With an Updated List of Participating Countries, Rev. 5; WHO/Pharm/82.4 Rev. 5; WHO: Geneva, 1997. https://apps.who.int/iris/handle/10665/63547 (Accessed February 15, 2023).
8.↵
Regulation (EC). No 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency (Text with EEA Relevance). Eur-Lex Web site. http://data.europa.eu/eli/reg/2004/726/oj (Accessed February 16, 2023).
9.↵
ICH Current Members and Observers. ICH Web site. https://www.ich.org/page/members-observers.
10.↵
Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S Web site. https://picscheme.org/en/about (Accessed February 16, 2023).
11.↵
International Pharmaceutical Regulators Programme (IPRP). IPRP Web site. https://www.iprp.global/page/mission (Accessed February 16, 2023).
12.↵
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 February 16, 2023).
13.↵
International Conference for Harmonisation. ICH Harmonised Guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH: Geneva, 2019. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf (Accessed February 15, 2023).
14.↵
World Health Organization. Guidelines on Procedures and Data Requirements for Changes to Approved Vaccines, Annex 4; WHO Technical Report Series No. 993; WHO: Geneva, 2015. https://www.who.int/publications/m/item/procedures-and-data-requirements-changes-to-approved-vaccines-annex-4-trs-no-993 (Accessed February 15, 2023).
15.↵
Fifty-fifth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations; WHO Technical Report Series No. 1033; WHO: Geneva, 2021. https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations (Accessed February 15, 2023)
16.↵
Pharmaceutical Quality—Regulatory Collaboration Pilots. Call for Industry Applications. ICMRA Web site. https://icmra.info/drupal/en/strategicinitatives/pqkms/pq_pilots_call_for_industry_applications (Accessed February 16, 2023).
17.↵
Project Orbis: A Framework for Concurrent Submission and Review of Oncology Products. FDA Web site. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis (Accessed February 16, 2023).
18.↵
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium. Therapeutic Goods Administration (TGA) Web site. https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium (Accessed February 16, 2023).
19.↵
EMA COVID-19 Assessments ‘OPEN’ to non-EU Regulators. EMA Web site. https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators (Accessed February 16, 2023).
20.↵
1. Deavin A.,
2. Adam S.,
3. Ausborn S.,
4. Nielsen A. S. B.,
5. Cappellini S.,
6. Colmagne-Poulard I.,
7. Gastineau T.,
8. Gonzalez-Martinez A.,
9. Meillerais S.,
10. Mortazavi C.
Path Forward to Optimise Post-Approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide: Joint Position from EFPIA, IFPMA and Vaccines Europe. Ther. Innov. Regul. Sci. 2023, 57 (1), 7–11.
OpenUrl
21.↵
1. Schofield I.
Why Convergence & Reliance Are Key to Managing the Challenges of CMC Post-Approval Changes. Pink Sheet, 2022. https://pink.pharmaintelligence.informa.com/PS147293/Why-Convergence–Reliance-Are-Key-To-Managing-The-Challenges-Of-CMC-PostApproval-Changes.
22.↵
1. Saint-Raymond A.,
2. Valentin M.,
3. Nakashima N.,
4. Orphanos N.,
5. Santos G.,
6. Balkamos G.,
7. Azatyan S.
Reliance Is Key to Effective Access and Oversight of Medical Products in Case of Public Health Emergencies. Expert Rev. Clin. Pharmacol. 2022, 15 (7), 805–810.
OpenUrl
23.↵
World Health Organization. Collaborative Procedure for Accelerated Registration. WHO Web site. https://extranet.who.int/pqweb/medicines/collaborative-procedure-accelerated-registration (Accessed February 15, 2023).
24.↵
World Health Organization. List of Transitional WLAs. https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/rev-list-of-transitional-wlas.pdf?sfvrsn=1f6c2140_7&download=true.
25.↵
2IFPMA. Points to Consider: The Importance of Sameness of Product in the Context of Regulatory Reliance. IFPMA Web site. https://ifpma.org/publications/points-to-consider-the-importance-of-sameness-of-product-in-the-context-of-regulatory-reliance/ (Accessed February 15, 2023).
26.↵
1. Doerra P.,
2. Valentina M.,
3. Nakashimab N.,
4. Orphanosc N.,
5. Santosd G.,
6. Balkamose G.,
7. Saint-Raymond A.
Reliance: A Smarter Way of Regulating Medical Products – The IPRP Survey. Expert Rev. Clin. Pharmacol. 2021, 14 (2), 173–177.
OpenUrl

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Keywords

[1] 1.↵
Dellepiane N.,
Pagliusi S.,
Akut P.,
Comellas S.,
De Clercq N.,
Ghadge S.,
Gastineau T.,
McGoldrick M.,
Nurnaeni I.,
Scheppler L.
Alignment in Post-Approval Changes (PAC) Guidelines in Emerging Countries May Increase Timely Access to Vaccines: An Illustrative Assessment by Manufacturers. Vaccine: X 2020, 6, 100075.
OpenUrl

[2] Dellepiane N.,

[3] Pagliusi S.,

[4] Akut P.,

[5] Comellas S.,

[6] De Clercq N.,

[7] Ghadge S.,

[8] Gastineau T.,

[9] McGoldrick M.,

[10] Nurnaeni I.,

[11] Scheppler L.

[12] 2.↵
Zerhouni E.,
Hamburg M.
The Need for Global Regulatory Harmonization: A Public Health Imperative. Sci. Transl. Med. 2016, 8 (338), 338ed6.
OpenUrl FREE Full Text

[13] Zerhouni E.,

[14] Hamburg M.

[15] 3.↵
Hoath C.,
Chang L.,
Iyer K. R.,
Kutza J.,
Murray S.,
Smith H.,
Payne R.
Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture; Regulatory Complexity and Impact. BioProcess Int 2016, 14, 38–43.
OpenUrl

[16] Hoath C.,

[17] Chang L.,

[18] Iyer K. R.,

[19] Kutza J.,

[20] Murray S.,

[21] Smith H.,

[22] Payne R.

[23] 4.↵
O’Brien J.,
Lumsden R. S.,
Diehl D. H.,
Macdonald J. C.
Building a Better Approach for the Benefit of Patients: 10 Pillars to Strengthen Regulatory Review Systems Globally. Ther. Innov. Regul. Sci. 2020, 54 (2), 283–292.
OpenUrl

[24] O’Brien J.,

[25] Lumsden R. S.,

[26] Diehl D. H.,

[27] Macdonald J. C.

[28] 5.↵
Rodriguez H.,
De Lucia M. L.
A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-Approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines. Front. Med. 2021, 8, 768376.
OpenUrl

[29] Rodriguez H.,

[30] De Lucia M. L.

[31] 6.↵
Gastineau T.
What Can Vaccines Learn from Aviation? Vaccine 2020, 38 (33), 5082–5084.
OpenUrl

[32] Gastineau T.

[33] 7.↵
World Health Organization, Division of Drug Management and Policies. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce: With an Updated List of Participating Countries, Rev. 5; WHO/Pharm/82.4 Rev. 5; WHO: Geneva, 1997. https://apps.who.int/iris/handle/10665/63547 (Accessed February 15, 2023).

[34] 8.↵
Regulation (EC). No 726/2004 of the European Parliament and of the Council of 31 March 2004 Laying down Community Procedures for the Authorisation and Supervision of Medicinal Products for Human and Veterinary Use and Establishing a European Medicines Agency (Text with EEA Relevance). Eur-Lex Web site. http://data.europa.eu/eli/reg/2004/726/oj (Accessed February 16, 2023).

[35] 9.↵
ICH Current Members and Observers. ICH Web site. https://www.ich.org/page/members-observers.

[36] 10.↵
Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S Web site. https://picscheme.org/en/about (Accessed February 16, 2023).

[37] 11.↵
International Pharmaceutical Regulators Programme (IPRP). IPRP Web site. https://www.iprp.global/page/mission (Accessed February 16, 2023).

[38] 12.↵
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 February 16, 2023).

[39] 13.↵
International Conference for Harmonisation. ICH Harmonised Guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH: Geneva, 2019. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf (Accessed February 15, 2023).

[40] 14.↵
World Health Organization. Guidelines on Procedures and Data Requirements for Changes to Approved Vaccines, Annex 4; WHO Technical Report Series No. 993; WHO: Geneva, 2015. https://www.who.int/publications/m/item/procedures-and-data-requirements-changes-to-approved-vaccines-annex-4-trs-no-993 (Accessed February 15, 2023).

[41] 15.↵
Fifty-fifth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations; WHO Technical Report Series No. 1033; WHO: Geneva, 2021. https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations (Accessed February 15, 2023)

[42] 16.↵
Pharmaceutical Quality—Regulatory Collaboration Pilots. Call for Industry Applications. ICMRA Web site. https://icmra.info/drupal/en/strategicinitatives/pqkms/pq_pilots_call_for_industry_applications (Accessed February 16, 2023).

[43] 17.↵
Project Orbis: A Framework for Concurrent Submission and Review of Oncology Products. FDA Web site. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis (Accessed February 16, 2023).

[44] 18.↵
Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium. Therapeutic Goods Administration (TGA) Web site. https://www.tga.gov.au/international-activities/australia-canada-singapore-switzerland-united-kingdom-access-consortium (Accessed February 16, 2023).

[45] 19.↵
EMA COVID-19 Assessments ‘OPEN’ to non-EU Regulators. EMA Web site. https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators (Accessed February 16, 2023).

[46] 20.↵
Deavin A.,
Adam S.,
Ausborn S.,
Nielsen A. S. B.,
Cappellini S.,
Colmagne-Poulard I.,
Gastineau T.,
Gonzalez-Martinez A.,
Meillerais S.,
Mortazavi C.
Path Forward to Optimise Post-Approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide: Joint Position from EFPIA, IFPMA and Vaccines Europe. Ther. Innov. Regul. Sci. 2023, 57 (1), 7–11.
OpenUrl

[47] Deavin A.,

[48] Adam S.,

[49] Ausborn S.,

[50] Nielsen A. S. B.,

[51] Cappellini S.,

[52] Colmagne-Poulard I.,

[53] Gastineau T.,

[54] Gonzalez-Martinez A.,

[55] Meillerais S.,

[56] Mortazavi C.

[57] 21.↵
Schofield I.
Why Convergence & Reliance Are Key to Managing the Challenges of CMC Post-Approval Changes. Pink Sheet, 2022. https://pink.pharmaintelligence.informa.com/PS147293/Why-Convergence–Reliance-Are-Key-To-Managing-The-Challenges-Of-CMC-PostApproval-Changes.

[58] Schofield I.

[59] 22.↵
Saint-Raymond A.,
Valentin M.,
Nakashima N.,
Orphanos N.,
Santos G.,
Balkamos G.,
Azatyan S.
Reliance Is Key to Effective Access and Oversight of Medical Products in Case of Public Health Emergencies. Expert Rev. Clin. Pharmacol. 2022, 15 (7), 805–810.
OpenUrl

[60] Saint-Raymond A.,

[61] Valentin M.,

[62] Nakashima N.,

[63] Orphanos N.,

[64] Santos G.,

[65] Balkamos G.,

[66] Azatyan S.

[67] 23.↵
World Health Organization. Collaborative Procedure for Accelerated Registration. WHO Web site. https://extranet.who.int/pqweb/medicines/collaborative-procedure-accelerated-registration (Accessed February 15, 2023).

[68] 24.↵
World Health Organization. List of Transitional WLAs. https://cdn.who.int/media/docs/default-source/medicines/regulatory-systems/wla/rev-list-of-transitional-wlas.pdf?sfvrsn=1f6c2140_7&download=true.

[69] 25.↵
2IFPMA. Points to Consider: The Importance of Sameness of Product in the Context of Regulatory Reliance. IFPMA Web site. https://ifpma.org/publications/points-to-consider-the-importance-of-sameness-of-product-in-the-context-of-regulatory-reliance/ (Accessed February 15, 2023).

[70] 26.↵
Doerra P.,
Valentina M.,
Nakashimab N.,
Orphanosc N.,
Santosd G.,
Balkamose G.,
Saint-Raymond A.
Reliance: A Smarter Way of Regulating Medical Products – The IPRP Survey. Expert Rev. Clin. Pharmacol. 2021, 14 (2), 173–177.
OpenUrl

[71] Doerra P.,

[72] Valentina M.,

[73] Nakashimab N.,

[74] Orphanosc N.,

[75] Santosd G.,

[76] Balkamose G.,

[77] Saint-Raymond A.

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Worldwide Regulatory Reliance: Launching a Pilot on a Chemistry, Manufacturing, and Control Post Approval Change for a Vaccine

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