Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Project Orbis (cancer medicines)

Singapore · Health Sciences Authority · New drugs

Work-sharing or joint reviewHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Project Orbis (cancer medicines) in Singapore?

A framework led by the US FDA for joint review of cancer medicines with partner agencies, including Singapore. The FDA selects products with the US applicant. Filing in Singapore follows the normal registration rules, fees and target times, but agencies share their reviews. Each agency makes its own decision. A cancer medicine under FDA review that the FDA has selected for Project Orbis.

What are the steps of the Project Orbis (cancer medicines)?

1. FDA selects the product; 2. Filing with the agency; 3. Collaborative review; 4. Independent decision.

Does the Project Orbis (cancer medicines) rely on other regulators?

Yes. It relies on approvals from United States (work sharing).

Outcome: Registration in the Register of Therapeutic Products. The registration is kept by paying a yearly retention fee.

Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. FDA selects the productThe FDA picks candidates with the US applicant and invites partner agencies.
2. Filing with the agencyType A: filed within 30 days of the FDA filing. Type B: later, with concurrent review possible. Type C: after the FDA review, which is shared.
3. Collaborative reviewReview follows the standard procedures, fees and target times for therapeutic products, with shared information between agencies.
4. Independent decision

Requirements

What the applicant must provide or meet

Eligibility

Oncology product selected by the FDAThe FDA coordinates candidate selection with the US applicant; the agency then decides whether to take part.

Other

Share questions and answers from other agencies

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Reliance on other regulators

United StatesWork sharingOncology products in the FDA-coordinated Project Orbis. Type A filings are made within 30 days of the FDA filing.

Other routes in Singapore: New drug application, full evaluation, New drug application, abridged evaluation, New drug application, verification evaluation, New drug application for a registered active ingredient (NDA-2), Standard essential medicine application, Priority review, Access Consortium work sharing, Special access for an unregistered medicine (named patient). See all routes on the Singapore page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.