Table 4.
Summary characteristics of the joint assessment collaborations ORBIS, ACCESS and ASEAN JACG
| Characteristic | ORBIS | ACCESS | ASEAN JACG |
|---|---|---|---|
| Therapeutic areas | Oncology only; NME or efficacy supplement (indication extension) | Across indications; NME or efficacy supplements (indication extension), new active substances, generics and biosimilar drugs | Across indications |
| Application process | By invitation from FDA (however, may be requested by sponsors) | By application via expression of interest form 3–6 months prior to submission | Selection by NRA supported by list of priority pharmaceutical products |
| Participating countries |
US, Canada, Australia, Brazil, Israel, Singapore, Switzerland, UK, others to be determined Currently out of scope: EU, China Participating agencies have to agree on participation based on capacities prior submission |
Australia, Canada, Singapore, Switzerland, UK (must include at least 2 of these countries) | ASEAN NRAs: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand, and Vietnam (at least three must participate) |
| Dossier | Country-specific—similar in content, but each application should meet the local content requirements | Required to be overall the same dossier, local differences need to be highlighted | Overall same dossier |
| Time window for submission in participating countries |
Type A Orbis: “Simultaneous” Type B Modified Orbis: Within 3 months of FDA filing date Type C Written Report Only: post FDA regulatory action |
Within 2 weeks | Simultaneous submission |
| Regulatory pathways | Can be different (standard, priority, etc.—pathways can be mixed) | Same pathway required: either standard OR priority | Same pathway |
| Review process | Parallel review of dossiers, frequent telecons of participating agencies | Work-sharing assignment of lead agency per Module (M3-5); peer review and national phase | Parallel review. Assignment of lead agency to coordinate and facilitate assessment, liaise with sponsor and facilitate support from well-sourced NRA |
| Questions | Ideally consolidated, but not always the case | Consolidated, batched or rolling questions (agreed upfront), but extra national questions; fixed milestones | Consolidated |
| Decision making | Independent | Independent | Independent |
| Labelling decision | Independent | Independent | Independent (not specified as such) |
NME = New Medical Entity; US = United States; FDA = Food and Drug Administration; UK = United Kingdom; EU = European Union; NRA = National Regulatory Agency