The Ideal Pharmacopeia - Pharmaceutical Technology

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The Ideal Pharmacopeia

Pharmaceutical Technology
Volume 32, Issue 11, pp. 122-125

Skeptics of a harmonized pharmacopeia need to realize that there is already an important example of the creation of a single, unified, international standard where many differing standards had previously existed. The model for a global standard can be found in the European Pharmacopoeia. When it was created in 1964, Ph. Eur. was intended to guarantee the quality of medicines throughout European countries, an objective not unlike that which led to the creation of USP in 1820. However, there were two important differences: First, by 1964, modern systems were in place for drug manufacturing by pharmaceutical companies with review and approval by regulatory agencies throughout the world. Second, there was a clearly defined legislative and regulatory goal to ensure consistent drug quality throughout Europe. Ph. Eur. represents a model of international cooperation to forge a single pharmacopeial standard in Europe where multiple standards existed before. The Ph. Eur. standard is now the legal pharmacopeial requirement in 36 European countries, along with the European Union (EU). In addition, there are more than 20 observer states, including WHO, the Russian Federation, China, Australia, Brazil, and Canada who follow the work of Ph. Eur. It is suggested that this model can be further extended to result in a global or unified pharmacopeia.

There are several practical approaches for moving toward a single global standard embodied in the ideal pharmacopeia. Currently, the Pharmacopeial Discussion Group (PDG), with representatives from USP, Ph. Eur., and JP, is actively engaged in pharmacopeial harmonization efforts. Continuation of this challenging but important work by PDG is strongly encouraged, along with regulatory review of the harmonized outcomes through the International Conference on Harmonization (ICH) Q4B: Evaluation and Recommendation of Pharmacopeial Texts for Use in the ICH Regions process. Consideration should also be given to novel approaches that might speed up PDG harmonization efforts, as well as provide new opportunities to move toward globally consistent pharmacopeial standards. Discussion is underway to develop a process for prospective harmonization through even greater collaboration among the pharmacopeias in partnership with industry to achieve consistency for new monographs and general chapters. Mutual acceptance by regulatory agencies of the standards in USP, Ph. Eur., and JP could also help to eliminate non-value-added duplicate testing that results from the lack of pharmacopeial harmonization.

Some initial progress has been made in this respect through the European Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials, which states that reference to either Ph. Eur., USP, or JP is acceptable (5). Further progress can be found in the US Food and Drug Administration's Manual of Policies and Procedures on Acceptability of Standards from Alternative Compendia, which states that it is reasonable to accept an applicant's proposal to use a quality standard from Ph. Eur. or JP as part of the specifications for an excipient, drug substance, or drug product in the drug application, if the standard in Ph. Eur. or JP is equivalent to or better than the corresponding standard in USP (6). All these concepts—PDG/ICH harmonization, prospective harmonization, and mutual acceptance—form the basis for a unified pharmacopeia and were presented by industry to EU and US regulators at the Transatlantic Administrative Simplification (TAS) workshop on Medicines Regulation held in Brussels in November 2007 (7).

Pharmacopeial development and revision

The ideal pharmacopeia should be developed and revised through a transparent, consensus-based process that allows for public review and comment (e.g., Pharmeuropa, JP Forum, and USP Pharmacopeial Forum). It is counterproductive for the pharmacopeia to unilaterally develop standards. Using a consensus-based approach involving and preferably driven by primary stakeholders (regulatory agencies and industry), the pharmacopeias can continue to play an important role in healthcare through the development of monographs and applicable general test methodology for pharmaceutical ingredients and dosage forms.


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