Index of application status transparency and availability of public information for Project Orbis agencies
Abstract
The purpose of this paper is to provide a guideline for understanding and comparing the regulatory framework of Project Orbis Partners (POPs) and Project Orbis observers, with a focus on their approaches to drug approvals, rejections, and withdrawals. While each agency has its own regulatory framework and guidance, there are some similarities and differences between the language used to describe drug approvals, rejections, withdrawals, and the public availability of these decisions. Project Orbis is an international partnership of regulatory agency, led by the U.S. Food and Drug Administration (FDA), aimed at streamlining the submission and review processes to expedite the global availability of oncology medications for patients. Since its inception, Australia’s Therapeutic Goods Administration (TGA), Brazil’s National Health Surveillance Agency (ANVISA), Canada’s Health Canada (HC), Israel’s Ministry of Health (IMoH) Medical Technologies, Health Information, Innovation and Research (MTIIR) Directorate, Singapore’s Health Sciences Authority (HSA), Switzerland’s Swissmedic (SMC), and United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) have joined and become POPs. Other international agencies such as, the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) are currently observing Project Orbis, as of late 2023. They are not full Project Orbis partners but work closely with the FDA to facilitate oncology drug approval through international collaboration.
Running Title: An Index of the FDA and international regulators involved in Project Orbis looking at the similarities and differences between approval, rejection, and withdrawal characteristics of applications and public transparency of actions.
Keywords:
Global, Transparency, Approvals, Complete Response, Rejection, Withdrawal, Project Orbis Partners (POPs), AusPAR
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References
1. FDA. Project Orbis [Internet]. United States: FDA; Aug 2024 [cited 2023 Jul 05]. Available from:
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
2. Australian Government Department of Health Therapeutic Goods Administration. Australian Public Assessment Report (AusPAR) Guidance [Internet]. Australia: TGA; 2010 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/resources/resource/guidance/australian-public-assessment-report-auspar-guidance
3. Australian Government Department of Health Therapeutic Goods Administration. Provisional approval pathway: prescription medicines [Internet]. Australia: TGA [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/provisional-approval-pathway-prescription-medicines
4. Australian Government Department of Health Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG) [Internet]. Australia: TGA; 2018 Mar 20 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg
5. Australian Government Department of Health and Aged Care. Therapeutic Goods Administration. Phase 7: Decision [Internet]. Australia: TGA; 2021 Aug 12 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-prescription-medicine/application-process/prescription-medicines-registration-process/phase-7-decision
6. Australian Government Department of Health Therapeutic Goods Administration. Prescription medicines under evaluation [Internet]. Australia: TGA [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/resources/prescription-medicines-under-evaluation
7. Global Regulatory Partners. How are Health Products regulated with Brazil’s ANVISA? [Internet]. Brazil: ANVISA; 2023 Jul 11 [cited 2023 Aug 29]. Available from:
https://globalregulatorypartners.com/how-does-product-regulation-work-at-anvisa/
8. Global Regulatory Partners. Synthetic Drug Registration Requirement. Main Reasons for Registration rejection from ANIVSA [Internet]. Brazil: ANVISA; 2020 Oct 3 [cited 2023 Aug 29]. Available from:
https://globalregulatorypartners.com/brazils-anvisa-outlines-reasons-for-the-approval-and-rejection-of-registration-of-synthetic-drugs/
9. Government of Brazil. Queries – ANVISA National Health Surveillance Agency [Internet]. Brazil: ANVISA [cited 2023 Aug 29]. Available from:
https://consultas.anvisa.gov.br/#/documentos/tecnicos/
10. Gov.br Ministry of Health. Regulation of Products Drugs [Internet]. Brazil: ANVISA; 2020 Oct 29 [cited 2023 Aug 29]. Available from:
https://www.gov.br/anvisa/pt-br/english/regulation-of-products/drugs
11. Government of Canada. Notice of Compliance Database [Internet]. Canada: HC; 2023 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database.html
12. Government of Canada. Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs [Internet]. Canada: HC; 2018 Aug 21 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/premarket-transparency-initiatives-notice.html
13. Government of Canada. Advisories, Warnings and Recalls – Drugs and health products [Internet]. Canada: HC; 2023 Mar 07 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html
14. Government of Canada. How Drugs Are Reviewed in Canada [Internet]. Canada: HC; 2015 Feb 12 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html
15. Government of Canada. Regulatory Decision Summary [Internet]. Canada: HC; 2024 Mar 26 [cited 2024 Aug 02]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-decision-summary.html
16. Government of Canada. Guidance Document: Management of Drug Submissions & Applications [Internet]. Canada: HC; 2022 Aug 02 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html
17. Government of Canada. Drug and Health Product Submissions Under Review [Internet]. Canada: HC; 2023 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html
18. Government of Canada. Summary Basis Decision [Internet]. Canada: HC [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/summary-basis-decision.html
19. European Medicines Agency. What we publish and when [Internet]. Europe: EMA; 2022 May 25 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when
20. European Medicines Agency. Authorisation of Medicines [Internet]. Europe: EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
21. European Medicines Agency. From lab to patient: The journey of a medicine assessed by EMA [Internet]. Europe: EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/from-lab-to-patient-timeline#:~:text=The%20role%20of%20EMA%20is,of%20receipt%20of%20EMA%27s%20recommendation.
22. European Medicines Agency. How EMA evaluates medicines for human use [Internet]. EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/how-ema-evaluates-medicines#assessment-process-section
23. European Medicines Agency [Internet]. Europe: EMA; 2023 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation
24. Ministry of Health Israel. Israeli Drug Registry [Internet]. Israel: MTIIR; 2023 [cited 2023 Sep 28]. Available from:
https://israeldrugs.health.gov.il/
25. Ministry of Health Israel. Drug application procedure [Internet]. Israel: MTIIR; 2012 [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/hozer/Reg08_2012.pdf
26. Ministry of Health Israel [Internet]. Israel: MTIIR [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/Drugs/Registration/Pages/default.aspx
27. Ministry of Health Israel. Rejection of registration application [Internet]. Israel: MTIIR; 2009 Nov [cited 2023 Sep 28]. Available from:
http://www.health.gov.il/hozer/DR_15.pdf
28. Ministry of Health Israel. Appeal to the Director’s decision to reject an application for registration of a drug or a new indication or to impose restrictions on a drug as part of its registration [Internet]. Israel: MTIIR; 2009 Nov [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/hozer/DR_73.pdf
29. Pharmaceuticals and Medical Devices Agency (PMDA) [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/reviews-services/reviews/0001.html
30. Pharmaceuticals and Medical Devices Agency. List of Approved Products [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0003.html
31. Pharmaceuticals and Medical Devices Agency. Points to be considered by the review staff involved in the evaluation process of new drug [Internet]. Japan: PMDA; 2008 [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/files/000153830.pdf
32. Pharmaceuticals and Medical Devices Agency. Annual Report [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/about-pmda/annual-reports/0001.html
33. Singapore Government Agency Website HSA. Registration Overview of Therapeutic Goods [Internet]. Singapore: HAS; 2018 Dec 18 [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/register/overview/screening-evaluation
34. Singapore Government Agency Website HSA. Guidance on the Therapeutic Products [Internet]. Singapore: HSA;2023 [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/guidance-documents
35. Singapore Government Agency Website HSA. Guidance on the therapeutic products – Target Processing Timeline: Appendix 5 [Internet]. Singapore: HSA;2024 Aug [cited 2024 Aug 06]. Available from:
https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/appendix-5_target-processing-timeline.pdf?sfvrsn=2a3259a5_2
36. Singapore Government Agency Website HSA. Therapeutic Products – Listing of Approvals and Post-Registration Actions [Internet]. Singapore: HSA [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/approvals-and-post-reg-actions
37. Swissmedic. Swiss Public Assessment Report (SwissPAR) [Internet]. Switzerland: SMC [cited 2023 Sep 6]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html
38. Swissmedic. Swiss Publication Assessment Report (SwissPAR) Questions and Answers [Internet]. Switzerland: SMC; 2019 [cited 2023 Sep 6]. Available from:
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/faq-swisspar.pdf.download.pdf
39. Swissmedic. Authorisations of human medicine [Internet]. Switzerland: SMC [cited 2023 Sep 6]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations.html
40. GOV.UK. Guidance Medicines: apply for a variation to your marketing authorization [Internet]. United Kingdom: MHRA; 2014 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation
41. GOV.UK. Guidance Apply for a license to market a medicine in the UK [Internet]. United Kingdom: MHRA; 2014 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#rejection.
42. GOV.UK European Commission (EC) decision Reliance procedure [Internet]. United Kingdom: MHRA; 2021 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure
43. GOV.UK. Guidance Renewing marketing authorisations for medicines [Internet]. United Kingdom: MHRA; 2020 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/renew-marketing-authorisation-for-a-human-medicine
44. GOV.UK. Guidance 150-day assessment for national applications for medicines [Internet]. United Kingdom: MHRA; 2020 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#eligibility
45. GOV.UK. Guidance Find product information about medicines [Internet]. United Kingdom: MHRA; 2019 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/find-product-information-about-medicines
46. GOV.UK. MHRA. Products About This Service [Internet]. United Kingdom: MHRA [cited 2023 Sep 6]. Available from: https://products.mhra.gov.uk/about
47. GOV.UK. Guidance. Safety Public Assessment Reports [Internet]. United Kingdom: MHRA; 2019 [cited 2023 Sep 6]. Available from: https://www.gov.uk/guidance/safety-public-assessment-reports
48. JAMA Internal Medicine. Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and their Public Disclosure by Applicants [Internet]. United States: FDA; 2021 [cited 2023 Sep 6]. Available from:
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2775955#:~:text=Within%2060%20days%20of%20application,the%20reasons%20preventing%20full%20reviews.
49. FDA. Center for Drug Evaluation and Research (CDER). Manual of Policies and Procedures [Internet]. United States: FDA; 2007 [cited 2023 Sep 6]. Available from:
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwizh8z5ps2AAxUiElkFHYXJCRcQFnoECBMQAQ&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F72756%2Fdownload&usg=AOvVaw2mUNUdUs36UumbgEJ_rY0d&opi=89978449
50. FDA. Pre-market approvals are published in the Official Gazette, enabling marketing authorisation. The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective [Internet]. United States: FDA; 2017 Nov 24 [cited 2023 Sep 6]. Available from:
https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
51. FDA. Code of Federal Regulations: FDA Action on Applications and Abbreviated Applications. Title 21, Volume 5 [Internet]. United States: FDA; 2023 [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.4
52. FDA. Code of Federal Regulations: Complete Response Letter to the Applicant - Title 21, Volume 5, Part 314, Subpart D [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
53. FDA. Purple Book – Database of Licensed Biological Products [Internet]. United States: FDA [cited 2023 Sep 6]. Available from: https://purplebooksearch.fda.gov/#:~: text=The%20Purple%20Book%20database%20contains,products%2C%20and%20their%20reference%20products
54. FDA. Drugs@FDA Frequently Asked Questions [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page
55. FDA. Biological Approvals by Year [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year
56. Löfstedt R, Way D, Bouder F, Evensen D. Transparency of medicines data and safety issues–a European/US study of doctors’ opinions: what does the evidence show? Journal of Risk Research [Internet]. 2016 Jan 14 [cited 2024 Jun 25]; 19(9):1172-1184. Available from:
https://www.research.ed.ac.uk/en/publications/transparency-of-medicines-data-and-safety-issues-a-europeanus-stu
57. Grimmelikhuijsen S, Herkes F, Leistikow I, Verkroost J, Vries F, Zijlstra WG. Can decision transparency increase citizen trust in regulatory agencies? Evidence from a representative survey experiment. Regulation & Governance [Internet]. 2019 Sep 30 [cited 2024 Jun 25];15(1):17-31. Available from:
https://onlinelibrary.wiley.com/doi/full/10.1111/rego.12278
58. Hunter, Phillip. More transparency for clinical trial data, the decision by the European Medicines Agency to make clinical trial reports publicly available could provide a boon for biomedical research. EMBO reports [Internet]. 2014 Dec 4 [cited 2024 Jun 25];16: 21-23. Available from:
https://www.embopress.org/doi/full/10.15252/embr.201439894
59. Peter Papathanasiou, Laurent Brassart, Paul Blake, Anna Hart, Lel Whitbread, Richard Pembrey, Jill Kieffer, Transparency in drug regulation: public assessment reports in Europe and Australia. Drug Discovery Today [Internet]. 2016 [cited 2024 Jun 25]; volume 21(11):1806-1813. Available from: https://www.sciencedirect.com/science/ article/pii/S1359644616302434?via%3Dihub
60. Wieseler B, McGauran N. Secrecy or transparency? The future of regulatory trial data. CMAJ [Internet]. 2017 Feb 6 [cited 2024 Jun 25]; 189(5):E185-E186. Available from:
https://www.cmaj.ca/content/189/5/E185
https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis
2. Australian Government Department of Health Therapeutic Goods Administration. Australian Public Assessment Report (AusPAR) Guidance [Internet]. Australia: TGA; 2010 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/resources/resource/guidance/australian-public-assessment-report-auspar-guidance
3. Australian Government Department of Health Therapeutic Goods Administration. Provisional approval pathway: prescription medicines [Internet]. Australia: TGA [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/provisional-approval-pathway-prescription-medicines
4. Australian Government Department of Health Therapeutic Goods Administration. Australian Register of Therapeutic Goods (ARTG) [Internet]. Australia: TGA; 2018 Mar 20 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/products/australian-register-therapeutic-goods-artg
5. Australian Government Department of Health and Aged Care. Therapeutic Goods Administration. Phase 7: Decision [Internet]. Australia: TGA; 2021 Aug 12 [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-prescription-medicine/application-process/prescription-medicines-registration-process/phase-7-decision
6. Australian Government Department of Health Therapeutic Goods Administration. Prescription medicines under evaluation [Internet]. Australia: TGA [cited 2023 Aug 29]. Available from:
https://www.tga.gov.au/resources/prescription-medicines-under-evaluation
7. Global Regulatory Partners. How are Health Products regulated with Brazil’s ANVISA? [Internet]. Brazil: ANVISA; 2023 Jul 11 [cited 2023 Aug 29]. Available from:
https://globalregulatorypartners.com/how-does-product-regulation-work-at-anvisa/
8. Global Regulatory Partners. Synthetic Drug Registration Requirement. Main Reasons for Registration rejection from ANIVSA [Internet]. Brazil: ANVISA; 2020 Oct 3 [cited 2023 Aug 29]. Available from:
https://globalregulatorypartners.com/brazils-anvisa-outlines-reasons-for-the-approval-and-rejection-of-registration-of-synthetic-drugs/
9. Government of Brazil. Queries – ANVISA National Health Surveillance Agency [Internet]. Brazil: ANVISA [cited 2023 Aug 29]. Available from:
https://consultas.anvisa.gov.br/#/documentos/tecnicos/
10. Gov.br Ministry of Health. Regulation of Products Drugs [Internet]. Brazil: ANVISA; 2020 Oct 29 [cited 2023 Aug 29]. Available from:
https://www.gov.br/anvisa/pt-br/english/regulation-of-products/drugs
11. Government of Canada. Notice of Compliance Database [Internet]. Canada: HC; 2023 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/database.html
12. Government of Canada. Notice: Phase III of Pre-Market Transparency Initiatives for Prescription Drugs [Internet]. Canada: HC; 2018 Aug 21 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/premarket-transparency-initiatives-notice.html
13. Government of Canada. Advisories, Warnings and Recalls – Drugs and health products [Internet]. Canada: HC; 2023 Mar 07 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html
14. Government of Canada. How Drugs Are Reviewed in Canada [Internet]. Canada: HC; 2015 Feb 12 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drugs-reviewed-canada.html
15. Government of Canada. Regulatory Decision Summary [Internet]. Canada: HC; 2024 Mar 26 [cited 2024 Aug 02]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/regulatory-decision-summary.html
16. Government of Canada. Guidance Document: Management of Drug Submissions & Applications [Internet]. Canada: HC; 2022 Aug 02 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html
17. Government of Canada. Drug and Health Product Submissions Under Review [Internet]. Canada: HC; 2023 [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html
18. Government of Canada. Summary Basis Decision [Internet]. Canada: HC [cited 2023 Aug 29]. Available from:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/summary-basis-decision.html
19. European Medicines Agency. What we publish and when [Internet]. Europe: EMA; 2022 May 25 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when
20. European Medicines Agency. Authorisation of Medicines [Internet]. Europe: EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines
21. European Medicines Agency. From lab to patient: The journey of a medicine assessed by EMA [Internet]. Europe: EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/from-lab-to-patient-timeline#:~:text=The%20role%20of%20EMA%20is,of%20receipt%20of%20EMA%27s%20recommendation.
22. European Medicines Agency. How EMA evaluates medicines for human use [Internet]. EMA; 2019 Mar 04 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/how-ema-evaluates-medicines#assessment-process-section
23. European Medicines Agency [Internet]. Europe: EMA; 2023 [cited 2023 Sep 5]. Available from:
https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation
24. Ministry of Health Israel. Israeli Drug Registry [Internet]. Israel: MTIIR; 2023 [cited 2023 Sep 28]. Available from:
https://israeldrugs.health.gov.il/
25. Ministry of Health Israel. Drug application procedure [Internet]. Israel: MTIIR; 2012 [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/hozer/Reg08_2012.pdf
26. Ministry of Health Israel [Internet]. Israel: MTIIR [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/Drugs/Registration/Pages/default.aspx
27. Ministry of Health Israel. Rejection of registration application [Internet]. Israel: MTIIR; 2009 Nov [cited 2023 Sep 28]. Available from:
http://www.health.gov.il/hozer/DR_15.pdf
28. Ministry of Health Israel. Appeal to the Director’s decision to reject an application for registration of a drug or a new indication or to impose restrictions on a drug as part of its registration [Internet]. Israel: MTIIR; 2009 Nov [cited 2023 Sep 28]. Available from:
https://www.health.gov.il/hozer/DR_73.pdf
29. Pharmaceuticals and Medical Devices Agency (PMDA) [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/reviews-services/reviews/0001.html
30. Pharmaceuticals and Medical Devices Agency. List of Approved Products [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0003.html
31. Pharmaceuticals and Medical Devices Agency. Points to be considered by the review staff involved in the evaluation process of new drug [Internet]. Japan: PMDA; 2008 [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/files/000153830.pdf
32. Pharmaceuticals and Medical Devices Agency. Annual Report [Internet]. Japan: PMDA [cited 2023 Sep 5]. Available from:
https://www.pmda.go.jp/english/about-pmda/annual-reports/0001.html
33. Singapore Government Agency Website HSA. Registration Overview of Therapeutic Goods [Internet]. Singapore: HAS; 2018 Dec 18 [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/register/overview/screening-evaluation
34. Singapore Government Agency Website HSA. Guidance on the Therapeutic Products [Internet]. Singapore: HSA;2023 [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/guidance-documents
35. Singapore Government Agency Website HSA. Guidance on the therapeutic products – Target Processing Timeline: Appendix 5 [Internet]. Singapore: HSA;2024 Aug [cited 2024 Aug 06]. Available from:
https://www.hsa.gov.sg/docs/default-source/hprg-tpb/guidances/appendix-5_target-processing-timeline.pdf?sfvrsn=2a3259a5_2
36. Singapore Government Agency Website HSA. Therapeutic Products – Listing of Approvals and Post-Registration Actions [Internet]. Singapore: HSA [cited 2023 Sep 6]. Available from:
https://www.hsa.gov.sg/therapeutic-products/approvals-and-post-reg-actions
37. Swissmedic. Swiss Public Assessment Report (SwissPAR) [Internet]. Switzerland: SMC [cited 2023 Sep 6]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html
38. Swissmedic. Swiss Publication Assessment Report (SwissPAR) Questions and Answers [Internet]. Switzerland: SMC; 2019 [cited 2023 Sep 6]. Available from:
https://www.swissmedic.ch/dam/swissmedic/en/dokumente/zulassung/zl_hmv_iv/faq-swisspar.pdf.download.pdf
39. Swissmedic. Authorisations of human medicine [Internet]. Switzerland: SMC [cited 2023 Sep 6]. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations.html
40. GOV.UK. Guidance Medicines: apply for a variation to your marketing authorization [Internet]. United Kingdom: MHRA; 2014 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation
41. GOV.UK. Guidance Apply for a license to market a medicine in the UK [Internet]. United Kingdom: MHRA; 2014 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/apply-for-a-licence-to-market-a-medicine-in-the-uk#rejection.
42. GOV.UK European Commission (EC) decision Reliance procedure [Internet]. United Kingdom: MHRA; 2021 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure
43. GOV.UK. Guidance Renewing marketing authorisations for medicines [Internet]. United Kingdom: MHRA; 2020 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/renew-marketing-authorisation-for-a-human-medicine
44. GOV.UK. Guidance 150-day assessment for national applications for medicines [Internet]. United Kingdom: MHRA; 2020 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines#eligibility
45. GOV.UK. Guidance Find product information about medicines [Internet]. United Kingdom: MHRA; 2019 [cited 2023 Sep 6]. Available from:
https://www.gov.uk/guidance/find-product-information-about-medicines
46. GOV.UK. MHRA. Products About This Service [Internet]. United Kingdom: MHRA [cited 2023 Sep 6]. Available from: https://products.mhra.gov.uk/about
47. GOV.UK. Guidance. Safety Public Assessment Reports [Internet]. United Kingdom: MHRA; 2019 [cited 2023 Sep 6]. Available from: https://www.gov.uk/guidance/safety-public-assessment-reports
48. JAMA Internal Medicine. Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and their Public Disclosure by Applicants [Internet]. United States: FDA; 2021 [cited 2023 Sep 6]. Available from:
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2775955#:~:text=Within%2060%20days%20of%20application,the%20reasons%20preventing%20full%20reviews.
49. FDA. Center for Drug Evaluation and Research (CDER). Manual of Policies and Procedures [Internet]. United States: FDA; 2007 [cited 2023 Sep 6]. Available from:
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwizh8z5ps2AAxUiElkFHYXJCRcQFnoECBMQAQ&url=https%3A%2F%2Fwww.fda.gov%2Fmedia%2F72756%2Fdownload&usg=AOvVaw2mUNUdUs36UumbgEJ_rY0d&opi=89978449
50. FDA. Pre-market approvals are published in the Official Gazette, enabling marketing authorisation. The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective [Internet]. United States: FDA; 2017 Nov 24 [cited 2023 Sep 6]. Available from:
https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective
51. FDA. Code of Federal Regulations: FDA Action on Applications and Abbreviated Applications. Title 21, Volume 5 [Internet]. United States: FDA; 2023 [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=314&showFR=1&subpartNode=21:5.0.1.1.4.4
52. FDA. Code of Federal Regulations: Complete Response Letter to the Applicant - Title 21, Volume 5, Part 314, Subpart D [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.110
53. FDA. Purple Book – Database of Licensed Biological Products [Internet]. United States: FDA [cited 2023 Sep 6]. Available from: https://purplebooksearch.fda.gov/#:~: text=The%20Purple%20Book%20database%20contains,products%2C%20and%20their%20reference%20products
54. FDA. Drugs@FDA Frequently Asked Questions [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page
55. FDA. Biological Approvals by Year [Internet]. United States: FDA [cited 2023 Sep 6]. Available from:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/biological-approvals-year
56. Löfstedt R, Way D, Bouder F, Evensen D. Transparency of medicines data and safety issues–a European/US study of doctors’ opinions: what does the evidence show? Journal of Risk Research [Internet]. 2016 Jan 14 [cited 2024 Jun 25]; 19(9):1172-1184. Available from:
https://www.research.ed.ac.uk/en/publications/transparency-of-medicines-data-and-safety-issues-a-europeanus-stu
57. Grimmelikhuijsen S, Herkes F, Leistikow I, Verkroost J, Vries F, Zijlstra WG. Can decision transparency increase citizen trust in regulatory agencies? Evidence from a representative survey experiment. Regulation & Governance [Internet]. 2019 Sep 30 [cited 2024 Jun 25];15(1):17-31. Available from:
https://onlinelibrary.wiley.com/doi/full/10.1111/rego.12278
58. Hunter, Phillip. More transparency for clinical trial data, the decision by the European Medicines Agency to make clinical trial reports publicly available could provide a boon for biomedical research. EMBO reports [Internet]. 2014 Dec 4 [cited 2024 Jun 25];16: 21-23. Available from:
https://www.embopress.org/doi/full/10.15252/embr.201439894
59. Peter Papathanasiou, Laurent Brassart, Paul Blake, Anna Hart, Lel Whitbread, Richard Pembrey, Jill Kieffer, Transparency in drug regulation: public assessment reports in Europe and Australia. Drug Discovery Today [Internet]. 2016 [cited 2024 Jun 25]; volume 21(11):1806-1813. Available from: https://www.sciencedirect.com/science/ article/pii/S1359644616302434?via%3Dihub
60. Wieseler B, McGauran N. Secrecy or transparency? The future of regulatory trial data. CMAJ [Internet]. 2017 Feb 6 [cited 2024 Jun 25]; 189(5):E185-E186. Available from:
https://www.cmaj.ca/content/189/5/E185
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Lee SH, Hotaki LT, Oh K, Samuel J, de Villiers K, Eshetie K, Looi YH, Atiek E, Cudre-Mauroux F, Rohr U-P, Searle G, Santos LN, da. S. Andreoli SC, Aoi Y, Hirata M, Voltz-Girolt C, Aicardo C, Cain C, Naggan T, Boehm-Cagan A, Hirsch-Vexberg M, Luxenburg O, Ahmed N, Johnson L, Hunt M, Vu D, Theoret MR, Spillman D, de Claro RA. Index of application status transparency and availability of public information for Project Orbis agencies. Int J Drug Reg Affairs [Internet]. 2024Sep.15 [cited 2026Jan.18];12(3):55-. Available from: https://www.ijdra.com/index.php/journal/article/view/699
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