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30 BioPharm International eBook September 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series Monograph Development (Prospective Harmonization) C-LOS National Pharmacopoeias (Japan, Brazil, Russia, India, China, Korea) 6 Critical Markets Methods/ Specifications: RFT Strategy: Proactive Compliance External Advocacy Regulatory ∆ Implementation Global Pharmacopoeias (USP, EP, BP) Acceptable in >150 Countries Plan Plan Execute Review: Proposals Review: Official Compendial Review Process Surveillance Teams and Partnerships to develop and execute implementation plans for ongoing compendial compliance. Also: Opportunity for Advocacy. Compendial ∆ Implementation Compliance Process ∆ Implementation Change Control (Quality, Sites, Regulatory) Figure 1. Compendial end-to-end process. FIGURE COURTESY OF THE AUTHORS multilateral agreements between pharmacopoeias, and supported by monographs that are contrib- uted by bio/pharmaceutical com- panies. The work of prospective harmonization—which is mutu- ally benef icial to the industr y, pharmacopoeias, regulators, and ultimately to global patients—has resulted in the successful develop- ment of many new compendial standards that are globally accept- able and applicable and serves as a model for proactive partnership between the industry and phar- macopoeias. There is another opportunit y even further upstream to facili- tate compliance, which could be considered the beginning of com- pendial activities within a com- pany. This opportunit y may be described as compendial line-of- sight (C-LOS), which is aimed at developing a na ly t ica l met hods and specifications for drug prod- ucts and their ingredients that a re r ight-f irst-t ime ( R F T ). At a practical level, this means g iv- ing visibility to groups involved in product and method develop- ment regarding the expectations and norms of pharmacopoeias, so this understanding can be incor- porated at the appropriate stage in the product lifecycle and reflected in global drug product registra- tions. For all the potential ben- efit and simplification that could be achieved through C -LOS, it must also be acknowledged that it has rarely been incorporated in the processes for dr ug develop - ment in bio/pharmaceutical com- panies, due to limited resources a nd compet i ng pr ior it ies. T he goal of C-LOS, however, provides a potentially useful approach to compendial compliance, so con- sideration of how to move in this direction should still be pursued. Fundamentally, early conversation and collaboration across a variety of functional areas is necessary, w ith appropr iate processes and tools developed to make C-LOS possible and sustainable. The overall compendial activi- ties have long been carried out by multinational companies for changes published by the global pharmacopoeias, which may be defined as those that are accept- able to regulatory agencies well beyond the geographical bound- aries covered by the pharmaco- poeia. For example, regulators in many countries around the world accept compliance with the com- pendial standards published in the European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), and United States Pharmacopeia– National Formulary (USP–NF). But t he e nd-to - e nd desc r ipt ion of compendial affairs activities is not complete without recognizing the need to also address compendial standards listed in national phar- macopoeias, which form the legal requirements in these individual countries and are important for ensuring access to medicines for patients in these markets. Among the 40 pharmacopoeias published around the world that must be considere d i n order to ensu re compliance are those in Japan, China, India, Brazil, Russia, and Korea.