Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 47 A world without translation The principles of the ideal pharmacopoeia and compendial globalization ref lect industry's support for and alignment with pharmacopoeia initiatives that move toward harmo- nization. Industry's view of an aspirational goal for harmo- nization to achieve global pharmacopoeia standards was presented at a joint workshop held between the European Directorate for the Quality of Medicines and HealthCare (EDQM/Ph. Eur.) and the Chinese Pharmacopoeia (ChP) in 2016. Invited remarks were provided on behalf of EFPIA, the trade association representing the research-based phar- maceutical industry 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 protecting public health by creating public standards to help ensure the quality of medicines. The bio/pharmaceutical industry's mission is to provide medicines that extend and improve the lives of patients around the world, medicines with consistent qual- ity, complying with the applicable regulatory and pharma- copoeia requirements. When the standards published by the pharmacopoeias are not aligned, the differences increase the cost and complexity of compliance. When the standards published by the pharmacopoe- ias a re not a lig ned, t he d i f ferences i ncrease t he cost a nd complex it y of complia nce, potentia l ly hindering t he expor t and impor t of products bet ween countries and creating uncertainty in the supply of medicines to t he patients who need t hem. There are impor tant ini- tiatives under way to bring more consistenc y bet ween pharmacopoeia standards, including retrospective and prospective harmonization, the World Health Organiza- tion's (WHO's) Good Pharmacopoeial Practices (9), and greater col laboration a mong t he pharmacopoeias. At- tendees at the joint workshop were asked to imagine con- sistent standards published by the pharmacopoeias in the languages needed by their stakeholders … to imagine a global pharmaceutical industry that can ensure compli- ance with these standards, because they contain consis- tent requirements … and to imagine regulators who can use these globally consistent pharmacopoeia standards to help ensure the quality of medicines. U ltimately, attendees were asked to imagine t he pa- tients around t he world who wou ld be able to receive medicines wit h consistent qua lit y, wherever t he medi- cines are manufactured. To imagine this world, where there is no need for translation, because the pharmaco- poeias are saying the same thing. How do we get there? Pharmacopeias and stakeholders get there through ret- rospective, prospective, and informal harmonization to achieve globa l pharmacopoeia standards, through im- plementation 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 availability of medicines with consistent quality for patients around t he world. There are ma ny pat hways to achieve compendia l harmonization, and severa l ap- proaches are currently underway. Industry's perspective on the ideal pharmacopoeia and approaches to achieve compendia l g loba lizat ion suppor t t hese ongoing ha r- monization activities. Subsequent articles in this series will describe how the industr y still faces challenges in comply ing with compendia l standards, whether those standards are harmonized or not Acknowledgment The authors gratefully acknowledge the contribution of Susan J. Schniepp for her technical review and helpful suggestions during the preparation of this series of ar- ticles. References 1. The Free Dictionar y, w w tion 2. Merriam-Webster Dictionary, w w dictionar y/convergence 3. USP, "Pharmacopeial Discussion Group (PDG),", w w 4. EDQM, "International Harmonisation,", w w w. 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 Tech- nology 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 Indus- tries and Associations (EFPIA) at the Workshop "The Chi- nese and European Pharmacopoeias–The New Editions," Strasbourg, France, October 17, 2016. 9. WHO, Good Pharmacopoeial Practices, WHO Expert Com- mittee on Specifications for Pharmaceutical Preparations Fiftieth Report, Technical Report Series No. 996, Annex 1, pp. 67-85 (2016). PT

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