Snapshot

The Abridged Evaluation of New Drugs pathway has been developed by the Thailand Food and Drug Administration of Thailand.

This pathway can be used where new drugs, biologics and vaccines..

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 Canada EU-EMA Japan Singapore Switzerland United Kingdom United States

Target time assessment is New drugs: 180 working days (wd); Biologics: 200 wd; Vaccines: 250 wd. *Priority review – New drugs: 150 wd; Biologics: 180 wd; Vaccines: 180 wd priority. .