PDG Announces Global Membership Initiative

August 30, 2024

Rockville, MD - The Pharmacopeial Discussion Group (PDG) is excited to announce the launch of the next phase of its global expansion initiative aimed at increasing convergence of harmonized pharmacopeial standards. This initiative will be the start of a process over the next couple of years to welcome additional pharmacopeias as new members.

Pharmacopeias interested in becoming members are encouraged to review the entry criteria, framework, and reference information. They are required to submit a statement of intent to PDG by September 15, 2024, and the formal application by December 31, 2024.

Founded in 1989, the PDG brings together pharmacopeias to harmonize excipient monographs and selected general texts. Last year, the founding members - the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP) - welcomed the Indian Pharmacopoeia Commission (IPC) as the fourth member. IPC joining PDG marked the culmination of a pilot program launched in 2022 which laid the groundwork for this global initiative.

The PDG has successfully harmonized and maintains 31 general chapters, including key analytical procedures such as chromatography, dissolution testing, sterility, and microbiological examination. In addition, the PDG has harmonized 48 excipient monographs and has approximately 20 new texts in its pipeline. The PDG remains committed to promoting the recognition of harmonized pharmacopeial standards to achieve global convergence.

The PDG invites all interested world pharmacopeias to visit the website for further information regarding PDG and ensure potential applicants meet the entry criteria.

About the PDG

Pharmacopoeial standards play a critical role in ensuring public health by setting quality expectations for each stage in the drug manufacturing process. Many manufacturers and regulatory agencies around the globe use the same standards to test for characteristics like identity, purity, potency and performance. The purpose of the PDG is to facilitate harmonisation of select pharmacopoeial standards (including excipient monographs and select general chapters) on a global level. Harmonisation reduces manufacturers' burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopoeial requirements that vary across geographies. PDG strives to maintain a consistent level of science across the pharmacopoeias, with the shared goal of protecting public health.

About USP

USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality resources and standards for medicines, dietary supplements and food ingredients. Through our resources, standards, advocacy and education, USP helps increase the availability of quality medicines, supplements and foods for billions of people worldwide. For more information, visit: www.usp.org.

USP Media Contact:
Nazila Fathi
[email protected]
(301) 816-8547

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