Pharmacopoeia/Industry/Agency Global Dialogue on Compendial Compliance and Harmonization Continues, with Medicine Availability at Stake

Industry, regulatory authorities and pharmacopoeias continue to explore ways to address the difficult challenges of complying with and harmonizing compendial and regulatory requirements in the effort to ensure and enhance the availability of medicines around the world.

The need to comply with compendial requirements as published by the United States Pharmacopeia (USP) and European Pharmacopoeia (EP or Ph. Eur.) is widely recognized. 

However, compliance with the varying requirements in the roughly three dozen other pharmacopoeias published in the world – including those of Japan, China, Russia, Korea, India, and Brazil – is not as well understood, and is complicated by differences in the general chapters and monographs for drug products, active ingredients and excipients. 

Another complication is the potential for differences between the requirements published in the pharmacopoeias and those contained in approved drug product registrations.

Among the venues where international stakeholders convened during 2018 to share their experience and their ideas on addressing the problems of compendial compliance and convergence was the inaugural PDA Europe Pharmacopoeia Conference held in Vienna, Austria in May.

Presenting at the conference were representatives of the USP and EP and the pharmacopoeias of Japan (JP) and the Eurasian Economic Union (EAEU). They contributed their thinking on the current status and future role of pharmacopoeias, and described specific initiatives to facilitate compendial convergence, including process improvements by the USP/EP/JP-based Pharmacopoeial Discussion Group (PDG) in its efforts to harmonize general chapters and excipient monographs. 

Also brought into focus were WHO’s recent International Meetings of World Pharmacopoeias (IMWP) and the associated development of Good Pharmacopoeial Practices (GPhP), which define approaches and policies in establishing compendial standards with the ultimate goal of harmonization. 

Pharmacopoeia activities related to operational flexibility and quality by design (QbD) in the pharmaceutical industry were another focus of attention, along with some unique challenges associated with compendial standards for biotherapeutic products.

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