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As analytical procedures may be affected by the presence of excipients and/or the manufacturing process selected, demonstration that the testing procedures described in a finished product monograph are suitable for the specific product will need to be included in the marketing authorization dossier. monograph, detailing its composition, pharmaceutical development, manufacture, control, container/closure system, and stability.
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In line with the requirements for all compendial APIs, a full dossier will need to be submitted to the licensing authorities for a finished product covered by a Ph.Eur. In addition, finished product monographs, like all other API and excipient monographs, while legally binding and reflecting the state of the art, are not intended to be a “regulatory straitjacket” that stifles innovation. As for all monographs, the elaboration and revision of finished product monographs will be subject to public consultation and take into account current scientific knowledge and relevant medicinal products authorized at the time. Commission, as it does for all its API and excipient monographs, will only elaborate monographs on products that have been authorized in at least one of its member states and that contain an API for which a monograph has already been published in the Ph.Eur. Finished product monographs will cover different formulations and strengths (whenever possible) of the same dosage form containing the same API. Commission’s policy that each finished product monograph, taken as a whole, should provide a reliable basis for making an independent judgement as to the quality of the preparation.
During the elaboration of the finished product monograph, a monograph for the active substance sitagliptin phosphate monohydrate was also drafted, for which the consultation period ended in March 2014. For this monograph, like all other monographs based on a single-source product, broad public consultation is even more important than for multi-source products to ensure that the resulting acceptance criteria and test methods are indeed robust and applicable to a wide range of products.
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Based on the commission’s unanimous decision, the draft monograph on sitagliptin phosphate tablets-a text elaborated by the working party in close collaboration with the innovator-is now published in Pharmeuropa, the Ph.Eur.’s free online-forum, for public comments (1). Commission for approval at its March 2014 session.
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A dedicated working party composed solely of representatives of licensing authorities and official medicines control laboratories was set up and assigned two tasks: to elaborate draft monographs on two finished products, one for which the API is still under patent in Europe (a so-called “single-source” product) and a second one for which generic drugs are already on the market (“multi-source” product), and to draft a guidance document to explain the rationale for finished product monographs and how to use them, intended for both regulators and the industry.įinished product monographs Since then, the pilot phase has concluded and the outcome was presented to the Ph.Eur. Commission decided in 2012 to initiate a pilot phase on the feasibility of finished product monographs. Following intensive discussions with the European Medicines Agency’s Joint CHMP/CVMP Quality Working Party, the Ph.Eur. Based on the feedback received from stakeholders in the context of its tri-annual scientific conference held in Prague in October 2010, the Ph.Eur. They are needed by official medicines control laboratories for their market surveillance studies they support and facilitate the development of generic drugs, which are crucial to ensure the sustainability of today’s healthcare systems, and they may also be useful to regulatory authorities by facilitating the assessment of respective quality dossiers. It has to be acknowledged, however, that there is a clear demand for these monographs.