Harmonized Standards Overview

Currently, USP engages with our international partners in the following venues

  1. Pharmacopeial Discussion Group (PDG): Formed in 1989, the PDG seeks to harmonize pharmacopeial standards (retrospective harmonization of excipient monographs and selected general chapters) between the USP, the European Pharmacopeia, and the Japanese Pharmacopeia through a formal, step wise process.  The Indian Pharmacopoeia Commission (IPC) officially joined as a member in the PDG on October 2023.
  2. Prospective Harmonization and Bilateral Agreements. Focused on creating harmonized monographs across multiple pharmacopoeias using submissions for sponsors in a collaborative fashion with partner pharmacopeias.
  3. Adopt/Adapt Agreements: Started in the 1990’s, these agreements allow for the grant of rights to copy and adapt USP standards, allowing other pharmacopeias or regulatory authorities to incorporate USP standards into their own compendia as a means to promote harmonization or convergence toward harmonized standards.
  4. WHO Good Pharmacopeial Practices (GPhP). Development of a common framework for the pharmacopeial standards-setting process (a guideline) in the context of the WHO’s International Meeting of World Pharmacopoeias, with the WHO Expert Committee on Specifications for Pharmaceutical Preparations overseeing the activity.
  5. USP Exchange Programs: Sharing of scientific knowledge among global organizations involved in standards setting and the effective use of standards. The USP Visiting Scientist and Executive Exchange Programs (VSP and EEP) promote international harmonization of standards through the exchange of scientific staff and information with global collaborators and organizations committed to pharmacopeial advancement.

In addition, USP staff and volunteers provide topic-specific input into the standard-setting activities of the WHO International Pharmacopeia, the WHO Expert Committee on Biological Standardization and ICH working groups on quality topics.