BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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www.biopharminternational.com September 2019 BioPharm International eBook 41 Regulatory Sourcebook Pharmacopoeia Compliance Series Continued progress toward this goal is in the interest of global patients and society as a whole. A WORLD WITHOUT TRANSLATION The principles of the ideal pharma- copoeia and compendial globaliza- tion reflect industry's support for and alignment with pharmacopoeia initiatives that move toward har- monization. Industry's view of an aspirational goal for harmoniza- tion to achieve global pharmaco- poeia standards was presented at a joint workshop held between the European Directorate for the Quality of Me d ic i ne s a nd He a lt hC a r e (EDQM/Ph. Eur.) and the Chinese Pharmacopoeia (ChP) in 2016. Invited remarks were provided on behalf of EFPIA, the trade association rep- resenting the research-based phar- maceutical industr y in Europe, and whose members supply many important medicines that contribute to the health of patients in Europe, China, and around the world. In these remarks (8), it was noted that the pharmacopoeias and industry share a common goal, which is to ensure the availability of medicines for people around the world. The pharmacopoeia's core mission is pro- tecting public health by creating public standards to help ensure the quality of medicines. The bio/phar- maceutical industry's mission is to provide medicines that extend and improve the lives of patients around the world, medicines with consistent quality, complying with the appli- cable regulatory and pharmacopoeia requirements. When the standards published by the pharmacopoeias are not aligned, the differences increase the cost and complexity of com- pliance, potentially hindering the expor t and impor t of products bet ween countries and creating uncertainty in the supply of medi- cines to the patients who need them. There are important initia- tives underway to bring more con- sistency between pharmacopoeia standards, including retrospective and prospective harmonization, the World Health Organization's ( W HO 's) G o o d Ph a r m a co p o e i al Practices (9), and greater collabora- tion among the pharmacopoeias. Attendees at the joint workshop were asked to imagine consistent standards published by the pharma- copoeias in the languages needed by their stakeholders … to imag- ine a global pharmaceutical indus- try that can ensure compliance with these standards, because they contain consistent requirements … and to imagine regulators who can use these globally consistent pharmacopoeia standards to help ensure the quality of medicines. Ultimately, attendees were asked to imagine the patients around the world who would be able to receive medicines with consistent quality, wherever the medicines are man- ufactured. To imagine this world, where there is no need for trans- lation, because the pharmacopoe- ias are saying the same thing. How do we get there? Pharmacopoeias and stakeholders get there through ret rospec t ive, prospec t ive, a nd informal harmonization to achieve global pharmacopoeia standards, through implementation of WHO's Good Pharmacopoeial Practices and through ongoing collaboration. Continued progress toward this goal is in the interest of global patients and society as a whole. CONCLUSION Global pharmacopoeia standards would help to support the avail- ability of medicines with consis- tent quality for patients around the world. There are many pathways to achieve compendial harmoni- zation, and several approaches are currently underway. Industry's per- spective on the ideal pharmaco- poeia and approaches to achieve comp end ia l g loba l i z at ion sup - port these ongoing harmonization activities. Subsequent articles in this series will describe how the industry still faces challenges in complying with compendial stan- dards, whether those standards are harmonized or not. 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. REFERENCES 1. The Free Dictionary, www. thefreedictionary.com/harmonization 2. Merriam-Webster Dictionary, www. merriam-webster.com/dictionary/ convergence 3. USP, "Pharmacopeial Discussion Group (PDG)," USP.org, www.usp.org/ harmonized-standards/pdg 4. EDQM, "International Harmonisation,"EDQM.eu, www. edqm.eu/en/international- harmonisation-614.html 5. S. Keitel, Pharmaceutical Technology 34 (4), pp. 120-121 (April 2010). 6. J. M. Wiggins, J. A. Skutnik, J. L. Shimek-Cox, and N. A. Schwarzwalder, Pharmaceutical Technology 32 (11), pp. 122-125 (November 2008). 7. J. M. Wiggins and H. D. Schneider, Jr., Pharmaceutical Technology 36 (4), pp. 94-101 (April 2012). 8. J. M. Wiggins, "Importance of Pharmacopoeia Standards: Their Added Value for Stakeholders," Remarks provided on behalf of the European Federation of Pharmaceutical Industries and Associations (EFPIA) at the Workshop "The Chinese and European Pharmacopoeias–The New Editions," Strasbourg, France, October 17, 2016. 9. WHO, Good Pharmacopoeial Practices, WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth Report, Technical Report Series No. 996, Annex 1, pp. 67-85 (2016). BP

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