FRPath | Asia Region FRPs

- ASEAN harmonized requirements for drug registration (SIAHR)- Full JA
- Expedited Joint Assessment Procedure

- Abridged Route

- Conditional Approvals for New Drugs
- Prioritized Drug Review and Approval Pathway
- Breakthrough Therapy Designation (BTD)
- The Special Approval Pathway (SAP) for COVID-19 related products
- Priority Review

- Registration of Advanced Therapy Products

- Path IV (new life saving drugs)
- Path V (prior approved)

- The time-limited conditional approval system for regenerative medicines
- PMDA Conditional Early Approval
- Priority Review
- PMDA Sakigake (Pioneering Drug Designation)

- Verification Review
- Abbreviated Review
- Priority Pathway
- Orphan Drug Route
- Conditional Registration for Pharmaceutical Products During Disaster
- Conditional Registration for New Chemical Entities and Biologics in Malaysia

- Facilitated Registration of Applications
- Accelerated registration of WHO-prequalified products
- Orphan Drug Route
- Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019 (COVID-19) (INITIAL-DEU)
- Verification Review
- Abridged Review

- Verification - CECA Route
- GDA Verification Route
- GDA Abridged Route
- NDA Abridged Route
- NDA Verification Evaluation Route

- Prior Review

- Fast Track Review
- Priority Review

- Priority Review
- Accelerated Approval
- Abbreviated Review
- Taiwan Orphan Drug Pathway

- Abridged Evaluation of New Drugs

- Abridged Procedure
- Orphan Drug Route

Asia

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ASEAN

Brunei Darussalam

China

Hong Kong

Indonesia

Japan

Malaysia

Philippines

Singapore

South Korea

Sri Lanka

Taiwan (Chinese Taipei)

Thailand

Vietnam