Prequalification of Active Pharmaceutical Ingredients - Information for applicants

General information

• An introduction to WHO prequalification of active pharmaceutical ingredients (APIs)
  

• Who can participate

• What information is required
  

  • Application form

• Where this information should be submitted

• What requirements and standards must be met in order to be prequalified
  

• What information is published in the WHO List of Prequalified Active Pharmaceutical Ingredients

• The Confirmation of API Prequalification Document
  

• What happens if an API master file (APIMF) has already been submitted in relation to a finished pharmaceutical product (FPP) that has been prequalified
  

• What happens if the APIMF or API site has already been accepted by a Stringent Regulatory Authority

• Disclaimer
  

• Confidentiality

• Meetings with PQP Assessors

  • Meeting Request Form

Changes to the details of a prequalified API

• Information on the requirements for making changes to the details of a prequalified API can be found under the section Amendments (changes) to an Accepted APIMF

Active pharmaceutical ingredients - Expression of Interest

• Invitations for Expression of Interest (EOI - (Updated 12 November 2012)

List of prequalified Active Pharmaceutical Ingredients (APIs)

• List of prequalified APIs

Prequalification guidelines related to active pharmaceutical ingredients

• Guidance on technical content of an APIMF

Information for national medicines regulatory agencies (NMRAs)

• For NMRAs seeking further information on the assessment of prequalified APIs

Useful Links

• Current International Pharmacopoeia (Ph.Int.) Monographs

• Draft Pharmacopoeia (Ph.Int.) Monographs