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46 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series (5). It is also noted that a "harmonized regulatory system, with mutual recognition of assessment/decision-making by licensing authorities and inspectors, including globally harmonized pharmacopoeias, would be beneficial in sev- eral ways" (5). Pharmacopoeias can "also play an important role in protecting patients from some of the downsides of globalization, namely adulteration and counterfeiting of medicines," however the "prevention of drug adulteration or counterfeiting is not achievable by a pharmacopoeia or any other stakeholder alone" (5). Still, it seems evident that global pharmacopoeia standards could help in this objective, providing consistent standards of quality for medicines to support patients around the world, whereas divergent compendial standards only serve to complicate the situation. Appropriate standardization means the pharmacopoeia would focus on the specific content that provides the greatest value to the bio/ pharmaceutical industry for the quality control of drugs. Ideal pharmacopoeia and compendial globalization–an industry perspective The bio/pharmaceutical industry has itself been discussing the benefits of "harmonization" in today's global pharma- copoeia environment. The purpose and role of the pharma- copoeias and the global picture were described in previous articles in this series. There are as many as 40 pharma- copoeias published by authorities around the world. The pharmacopoeias were established and evolved to ensure the quality of medicines and their ingredients for patients in a country or region. Today's global patient population was not necessarily part of the overall consideration for the pharmacopoeias, especially early in their development. As a result, the standards contained in the various pharmaco- poeias were not generally aligned, creating a challenge for the industry to comply with all the applicable requirements. Having struggled with the challenge of differing compen- dial standards for many years, discussion was initiated be- tween pharmaceutical industry representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceuti- cal Industries and Associations (EFPIA) to explore what might be described as the "ideal" pharmacopoeia. The re- sult of these discussions was a position paper, published in 2008, that presents this industry perspective (6). The paper stated that the ideal pharmacopoeia would provide appropriate standardization to facilitate drug registration and support regulatory agencies through a single, global compendial standard. Considering each of these points in turn, appropriate standardization means the pharmacopoeia would focus on the specific content that provides the greatest value to the bio/pharmaceutical industry for the quality control of drugs. Facilitating drug registration would be achieved by simplifying the preparation (by industry) and assess- ment (by regulators) of drug applications using reference to a common standard for generally accepted quality pa- rameters for pharmaceutical products and ingredients. Alignment between the pharmacopoeias and regulators is essential, so the ideal pharmacopoeia would include stan- dards that are consistent with the needs and expectations of regulatory authorities. Most importantly, the ideal phar- macopoeia would provide a single compendial standard that could be used worldwide. The industry perspective on the ideal pharmacopoeia provides a model for the fu- ture: a long-term goal that could achieve harmonization of compendial standards, further enhancing the role of the pharmacopoeias to support and promote global public health through safe and effective medicines with appropri- ate quality to benefit patients around the world. Another article from industry describes compendial globalization and achieving harmonization through stan- dardized practices and collaboration among the pharma- copoeias and health authorities (7). This article discusses the need for "consistent and appropriate quality require- ments for medicines because disharmonized standards do not provide additional value or benefit, but rather increase the cost and complexity of bringing medicines to patients worldwide." The approach to harmonization described as compendial globalization "provides a basis for the phar- macopoeias to work together in new ways with consistent processes coupled with sharing of information and work." The three principles that support compendial globaliza- tion are: • Standardized pharmacopoeial practices, which es- tablish a consistent approach for the pharmacopoe- ias to elaborate compendial standards • Pharmacopoeial collaboration, which enhances the cooperation among the pharmacopoeias to enable the development, sharing, and adoption of harmo- nized compendial standards • Regulatory acceptance, which ensures the participa- tion and agreement by regulatory authorities with the harmonized processes and outcomes in those countries where the pharmacopoeia standards apply. The pharmacopoeias and regulators around the world, in collaboration with their stakeholders, have been actively and successfully working toward the goal of harmoniza- tion for quite some time. These ongoing harmonization efforts are supported and encouraged by the bio/pharma- ceutical industry.