The Need for Pharmacopeial Harmonization - Pharmaceutical Technology

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The Need for Pharmacopeial Harmonization
In the context of international trade, the need to develop global quality standards for medicines is increasing.


Pharmaceutical Technology
Volume 37, Issue 4, pp. 36-38

Harmonization of APIs

In addition to PDG activities, Ph. Eur. and USP have initiated a bilateral pilot project on the prospective harmonization of monographs for APIs. So far, this project covers four substances that were still under patent at the time monograph elaboration was initiated and it has been run in close collaboration with two sponsors. All four monographs have now been adopted by the respective governing bodies of the Ph. Eur. and USP. Together with the sponsors, the two pharmacopeias have decided to extend the pilot phase to cover the revisions of these first four monographs to ensure a robust procedure is in place before a final decision is taken on the future process. In the meantime, the Japanese Pharmacopeia has also voiced its interest in participating in the project.

Since the setting up of the PDG and ICH, the industrial environment has changed. It is evident that harmonization between the three ICH regions is no longer sufficient in today’s world, where a high percentage of APIs come from outside Europe, Japan, and the US. Up to 80% of the volume of APIs used in the production of medicines for the European market come from India and China, with the cited figures varying depending on the source of data. The European Pharmacopoeia, therefore, is also actively involved in a number of other international harmonization projects; the most promising of which is the recent WHO initiative.

Good pharmacopeial practices

In early 2012, the WHO convened the pharmacopeias of the world for their first international meeting in Geneva. Representatives of 23 pharmacopeia secretariats from 21 countries, the EDQM/Council of Europe, and the WHO used the opportunity to exchange views on experiences, policies, and challenges. The discussions clearly identified the need to strengthen collaboration among pharmacopeias worldwide. Based on the experience and challenges with existing harmonization initiatives (such as the PDG) that focus on retrospective harmonization, it was acknowledged that new platforms open to all pharmacopeias who wished to participate would need to be identified for a global pharmacopeial harmonization process. However, any platform would need to respect that each pharmacopeia operates within a national or regional legal and regulatory framework. Hence, the main emerging proposal has been the development of Good Pharmacopeial Practices; a guidance document that would describe harmonized policies and approaches to monograph development, collaboration between pharmacopoeias, and interactions with stakeholders. Good pharmacopeial practices are intended to favor and facilitate future collaboration, work-sharing, and prospective harmonization between participating pharmacopeias.

The WHO has been asked to facilitate the elaboration of these good pharmacopeial practices under the auspices of its Expert Committee on Specifications. An initial drafting group has been formed, comprising representatives from Argentina, Brazil, the Ph.Eur., India, Japan, Mexico, Russian Federation, Ukraine, and USP, with editorial assistance being provided by the United Kingdom. As a truly global initiative, the entire process will be open to all pharmacopeias. A follow-up meeting, organized jointly by the WHO and the Fédération Internationale Pharmaceutique (FIP) in October 2012 in Amsterdam, gave the opportunity to the pharmacopeias to present this proposal to stakeholders and to collect feedback. As a consequence of this discussion, a second closed international meeting of world pharmacopeias is now planned to take place in India in April 2013, hosted by the Indian Pharmacopoeia Commission and co-organized with the WHO.

Preparation of a first draft of the Good Pharmacopoeial Practices guidance document as a basis for substantial discussions and progress at this meeting is well under way, with pharmacopeias from different continents sharing the work. The Ph. Eur. Commission supports these developments, which will help the pharmacopeias of the world to agree on harmonized, scientifically sound approaches and policies to ensure the quality of medicines for the benefit of patients around the world.


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