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www.biopharminternational.com March 2020 BioPharm International eBook 45 Regulatory Sourcebook Pharmacopoeia Compliance Series regulatory environment, one can envision the ChP will become more important in product registrations for the Asia Pacific region, alongside the JP. Clearly, for any company intending to license and market a drug product in China, compliance to the ChP is now mandatory and a strategy on how to achieve and maintain this compliance should be developed. Brazil Brazil joined ICH in November 2 016 (45) a nd implementat ion of s eve r a l IC H g u id a nce do c- uments has occurred or is being planned (46). This change w ill impact general chapters and mono- graph requirements in the most recently published 6th edition of the Brazilian Pharmacopoeia (FBras) and future editions in the com- ing years. Companies will need to monitor the publication for any changes that impact their compa- ny's products. Russia Russia is currently an ICH observer, and with this status, has not yet implemented any of the ICH guid- ance documents (47). However, the latest XIV edition of the Russian Pharmacopoeia (SP RF ) was pub- lished in December 2018, and it contains more than 60 revised or new general chapters. The addi- tion of chapters highlights the need for a company to establish moni- toring of the SP RF. The regulation requiring companies to perform gap assessment of their procedures aga inst t he Russia n nor mat ive document includes baseline com- pliance to the SP RF general chap- ters. Companies must comply with these requirements at the next license renewal for the drug prod- uct or by 2022, whichever comes first. Additionally, there is increased activity from the Russian Ministry of Health (MoH) to request the development of new product mono- graphs in the SP RF. This increased activity from the MoH indicates companies need to keep Russia on their radar to remain compliant. Let us make every effort to ensure that the pharmacopoeias reach a state of harmonization that will support the objective of 'no need for translation.' New regional pharmacopoeias E f for ts to establ ish new pha r- m a c o p o e i a s i n t h e E u r a s i a n Economic Union (EAEU), which includes Russia, and MESCOUR reg ion, wh ic h i nc ludes Bra z i l, were described in a previous arti- cle (3). As these new pharmaco- poeias come closer to reality in the coming years, it is important for a compendial affairs group to moni- tor the proposed documents being posted, to comment as appropriate, and to ensure the company has a plan to comply when the require- ments are published as official. It is not yet clear if these new pub- lications will replace the existing national pharmacopoeias in their respective countries or if the new regional publications will be har- monized with any of the remain- ing national pharmacopoeias that may continue to exist. CONCLUSION This brings to a close the series of articles on pharmacopoeia compli- ance. It is the authors' hope that t he infor mat ion presented has been helpful and the ideas for the f uture will continue, especially efforts aimed at harmonization to achieve global pharmacopoeia standards. There is a continuing need for all stakeholders to work toward the goal of a world where there is "no need for translation"; where the following is achieved: • Consistent standards pub- lished by pharmacopoeias in the languages needed by their stakeholders • A g loba l pha r maceut ic a l industr y that can ensure compliance with these stan- dards, because they contain consistent requirements • Reg u lator s who c a n u s e t hese globa lly consistent standards to help ensure the quality of medicines • No need for t ra nslat ion, because all the pharmaco- poeias are saying the same thing. The authors put forth a bold challenge to readers: let us make ever y effort to ensure that the pharmacopoeias reach a state of harmonization that will support the objective of "no need for trans- lation." If this goal of global phar- macopoeia standards is realized, even if it takes as long as 50 years, then it can be asserted that the pharmacopoeias, regulators, and the bio/pharmaceutical industry have truly done all they can in this important area, working together to further their shared mission of effectively serving patients globally. ACKNOWLEDGMENT The authors gratefully acknowl- edge the contribution of Susan J. Schniepp for her technical review and helpful suggestions during the preparation of this series of articles.