Snapshot

The WHO Prequalification of Medicines Programme (PQP) – Abridged Assessments pathway has been developed by the World Health Organization of WHO.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA Egypt Iceland India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Liechtenstein Malaysia Mexico Moldova, Republic of Norway Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States

Variable - It is dependent on how much time the applicant needs to provide responses to comments and questions from WHO.