The European Pharmacopoeia represents an important element in the European regulatory system for medicines. It is elaborated in a co-operation of experts from authorities, academia and industry, assisted by scientific staff from the European Directorate for the Quality of Medicines & HealthCare (EDQM). This article describes the principles of its elaboration with particular focus on the involvement of industry experts.
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| http://dx.doi.org/10.1016/j.ejps.2016.01.030 | DOI Listing |
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