Snapshot

The Conditional Approval for Emergency Use of Medical Products pathway has been developed by the of Thailand.

This pathway can be used where medical products for emergency use.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia EU-EMA Japan United Kingdom United States WHO

When a marketing authorization application is submitted for a product of major public health interest, the applicant may request an accelerated/fast track review as laid down in TFDA Regulation, then TFDA shall ensure that the marketing authorization decision is made within 200 days. Priority Review using Reference Drug Regulatory Authority Assessments further reduces timelines from 220 working days to 180 working days.