Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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44 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m 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. Click here to read the full article. HARMONIZATION EFFORTS BY PHARMACOPOEIAS AND REGULATORY AGENCIES iQoncept -

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