FRPath: Where the Roads to Accelerated Assessments Converge

- ASEAN Joint Assessment Procedure for Pharmaceutical Products
- Expedited Joint Assessment Procedure

- Emergency Use Authorization of COVID-19 Vaccines

- 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
- 1+ mechanism for approval of new drugs

- New Chemical Entity approved & marketed in other countries not approved in India.
- COVID-19 vaccine approval in India for restricted use in emergency situation
- Quick and Expeditious Review Process
- Accelerated Approval Process

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

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

- Import of New Drugs

- FRP- Reliance (Verification)
- FRP- Reliance (Abbreviated Review)
- Priority Pathway
- Orphan Drug Route
- Conditional Registration for Pharmaceutical Products During Disaster
- Conditional Registration for New Chemical Entities and Biologics in Malaysia
- Malaysia-Japan Cooperation on Simplifying Drug Review Procedure
- HSA-NPRA Generic Medicines Work Sharing Initiative

- Emergency Use Authorization for Drugs & Vaccines

- Collaborative Review Process (Accelerated registration of WHO-prequalified pharmaceutical products and vaccines
- Orphan Drug Route
- Registration of Drug Products under Emergency Use for the Coronavirus Disease 2019 (COVID-19) (INITIAL-DEU)
- Facilitated Review Pathway (Verification Review)
- Facilitated Review Pathway (Abridged Review)
- Emergency Use Authorization for Drugs & Vaccines for COVID-19

- Verification - CECA Route
- GDA Verification Route
- GDA Abridged Route
- NDA Abridged Route
- NDA Verification Evaluation Route
- Pandemic Special Access Route (PSAR)
- HSA-NPRA Generic Medicines Work Sharing Initiative

- Prior Review
- Global Innovative products on Fast Track (GIFT)

- Fast Track (Priority) Review

- Priority Review
- Accelerated Approval
- Abbreviated Review
- Taiwan Orphan Drug Pathway
- Breakthrough Therapy Designation

- Abridged Evaluation of New Drugs
- Conditional Approval for Emergency Use of Medical Products

- Abridged Procedure
- Orphan Drug Route

Asia

Choose a country below to begin

Asia

Choose a country below to begin

ASEAN

Bangladesh

Brunei Darussalam

China

Hong Kong

India

Indonesia

Japan

Macao

Malaysia

Pakistan

Philippines

Singapore

South Korea

Sri Lanka

Taiwan (Chinese Taipei)

Thailand

Vietnam