38 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook Pharmacopoeia Compliance Series
There are many pathways to achieve compendial harmonization; several approaches are currently underway. The
pharmacopoeias and regulatory agencies around the world, in collaboration with their stakeholders, have been actively
and successfully working toward this goal for quite some time. In "Harmonization Efforts by Pharmacopoeias and
Regulatory Agencies" in this series, the authors take a closer look at these ongoing efforts to harmonize compendial
standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.
The following topics are discussed:
• Pharmacopoeial Discussion Group. One long-standing activity focused on harmonization of compendial
requirements is that of the Pharmacopoeial Discussion Group (PDG), which comprises the European
Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP). Information
about the work of PDG is provided in this article, including their accomplishments to achieve consistent
pharmacopoeia standards in the Ph. Eur., JP, and USP. The challenge remains how to expand the harmonization
outcomes, recognizing the scope of the PDG activities is somewhat limited. These limitations in the PDG
work have led to additional harmonization activities to support and supplement the overall goal of global
pharmacopoeia standards.
• International Council for Harmonization. The International Council for Harmonization (ICH) brings together
the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug
registration. ICH's mission is to achieve greater harmonization worldwide to support safe, effective, and high-
quality medicines. Representatives from Ph. Eur., JP, and USP are either members or observers to the ICH process.
However, the connection between harmonization activities carried out by PDG and ICH is not well understood, and
further explanation is provided, with discussion of the ICH Q3 and Q4 guidelines and annexes.
• Contributions of the World Health Organization. The International Pharmacopoeia (Ph. Int.) from the World
Health Organization (WHO) supports the needs of developing countries by providing quality standards for
medicines that are listed in the WHO Model List of Essential Medicines. As an observer to the harmonization work
of both ICH and PDG, WHO is uniquely positioned to leverage the outcomes of that work and bring advantage by
expanding its reach throughout the world. WHO has taken a leadership role through several initiatives, convening
the International Meetings of World Pharmacopoeias (IMWP) to work toward harmonization of pharmaceutical
standards to safeguard quality and improve access to medicines. WHO has also facilitated the development of the
Good Pharmacopoeial Practices (GPhP) to encourage harmonization of compendial standards.
• Prospective and informal harmonization. The initiatives described thus far have focused on harmonization of
compendial standards already listed in the various pharmacopoeias—so-called "retrospective harmonization".
The GPhP guidance shifts the focus away from retrospective harmonization to facilitate "prospective
harmonization". This harmonization initiative has been undertaken through a collaboration between the bio/
pharmaceutical industry and the pharmacopoeias, in particular USP, Ph. Eur., and BP, with visibility provided
to other pharmacopoeias. The "prospective harmonization" effort has evolved to an "informal harmonization"
process between the participants and has resulted in the successful completion of several new, harmonized
monographs for small-molecule drug substances and products.
Global pharmacopoeia standards would help to support the availability of medicines with consistent quality for patients
around the world. Several approaches to achieve compendial harmonization are currently underway, including
the important work by PDG and WHO. Compendial harmonization is also taking place at the intersection of the
pharmacopoeias and ICH activities. The IMWP meetings have fostered greater collaboration among the pharmacopoeias
of the world and resulted in the GPhP guidance documents to help in the development of new standards that are
harmonized. Industry supports these ongoing harmonization activities.
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Harmonization Efforts by Pharmacopoeias and Regulatory Agencies