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Convention on the Elaboration of a European Pharmacopoeia, and amending of latest edition. ○ The 7th edition of the Ph. Eur. has been published in. European Pharmacopoeia - Ebook download as PDF File .pdf), Text File .txt ) or EUROPEAN PHARMACOPOEIA - 8th EDITION published 15 July EUROPEAN PHARMACOPOEIA EIGHTH EDITION Volume 1 EUROPEAN .. Pharmacopoeia Archives contain the 1 st Edition to 7 th Edition in PDF format.

Firstly, reference standards described in pharmacopoeial monographs and reference products necessary for the demonstration of biosimilarity are frequently confused.

Are we “preparing” radiopharmaceuticals?

Chapter 5. Secondly and most importantly, compliance to a monograph does not mean demonstration of biosimilarity. The EMA guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues states that comparison of the biosimilar to a publicly available standard, e. The unfortunate misuse of monographs in this respect has had a negative impact on the acceptance of monographs for biotherapeutic products by some stakeholders [ 15 ].

In current debates, we should bear in mind that the Ph. On the other hand, biosimilars are a type of product that were established to avoid unnecessary repetition of preclinical and clinical studies.

The regulatory pathway to be followed is defined in appropriate guidelines. Biosimilars are developed by companies and evaluated by licensing authorities, whether or not a compendial standard exists.

However, there has been some concern that monographs could actually hold up the regulatory process [ 2 ]. Moving on to biosimilars, 18 of the 21 biosimilar products approved in Europe are covered by a Ph.

If we look at the timeline, see Figure 5 , the EMA biosimilar guidelines were established in The first biosimilar to be approved was somatropin in The first erythropoietin EPO biosimilar was approved in , and since that time, four more EPO biosimilars have been approved. Both somatropin and EPO are covered by monographs. The EPO monograph has even been revised to accommodate the glycan distribution of one of these biosimilars.

And then there is filgrastim, for which a monograph was published in The first filgrastim biosimilar was approved in and since then, seven other filgrastim biosimilars have been approved.

Since all these biosimilars have been approved, one thing is certain: individual monographs have not blocked the licensing approval of these biosimilars.

If we take a closer look at the present situation, see Figure 6 , it is obvious that increasingly often, the monograph elaboration and biosimilar approval processes progress together. This is the case, for example, for insulin glargine and follitropin. An etanercept biosimilar was approved in early At the same time, a monograph for this substance was under enquiry in Pharmeuropa [ 9 ]. The outcome of the enquiry has been very positive, with comments received from both regulatory authorities and industry: these comments have been addressed and the monograph is soon to be published in the Ph.

During the same period, a monograph on pegfilgrastim was published and here as well, input from industry has been extremely constructive. The monograph itself is still being discussed as technical issues have arisen. In the meantime, at least three pegfilgrastim biosimilars are under assessment and many biosimilar manufacturers are requesting scientific advice for their products.

This is a very strong indication that there is a pressing need for a public standard for pegfilgrastim.

European Pharmacopoeia (Ph. Eur.) 9th Edition

To summarize, it has proven possible to overcome the challenges linked to the complexity of biologicals and to elaborate biotherapeutic product monographs. However, the success of the monograph elaboration process depends on the willingness of manufacturers to provide the information and candidate reference materials required for the process.

This has proven to be more problematic since the advent of biosimilars, probably due to misunderstandings about the role of Ph. Conclusion and way forward Individual monographs play a major role in ensuring that medicinal products throughout Europe meet the same quality standards, thereby contributing to patient safety. From a quality and standardization standpoint, biotherapeutic substances should not be viewed any differently from any other substance for which a monograph exists.

European Pharmacopoeia 8 0

The EDQM wishes to warmly thank all the manufacturers who contribute to the elaboration of monographs by sharing information on the quality part of their dossiers to serve as future public standards. The EDQM would also like to take this opportunity to draw attention to the outstanding work carried out by its experts in the complex exercise of monograph elaboration and hopes that, through debate and open dialogue, will identify how best to continue the work of standardization for biotherapeutic products.

Competing interests: None. Provenance and peer review: Commissioned; internally peer reviewed. References 1. Council of Europe. European Pharmacopoeia prepares for the future through exchange with stakeholders [homepage on the Internet].

Reflection Paper. The role of product-specific monographs for biotherapeutic products in pharmacopoeias future role of product specific monographs stakeholders.

Plenary Session: Role of monographs for biotechnological products. Roundtable Session: Product specific monographs. Session: Implications of product specific monographs for biotherapeutic products.

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Free access to online archives. Online Version: Completely cumulative, tablet and smartphone friendly. English and French. Changes inserted or deleted texts indicated in both html and pdf versions.

Possibility of adding RSS feeds for specific queries. Read the Technical Specifications Downloadable version: Completely cumulative and bilingual English and French. Allows easy access to the Ph.

It is also ideal for users who have more than one computer. Starting with Supplement 9. The European Pharmacopoeia and its requirements are legally binding in the member states of the European Pharmacopoeia Convention and the European Union. If you would like to know more about the European Pharmacopoeia, go to our European Pharmacopoeia section.

The Ph. Council for europe portal. You are here: Home European Pharmacopoeia Find information on Ph. Versions and Subscriptions The Ph. Book Version: The 8 th Edition will consist of two initial volumes 8. Each volume contains a complete table of contents and index.Book Version: The book version is available in English and French. The book version is available in English and French.

Rational for Method Selection - the specific characteristics of the cell preparation must be considered in the selection of the test method. The EDQM considers, on the contrary, that monographs in a multi-manufacturer situation have multiple advantages, since comparison of different products and procedures provides a forum for consensus and leads to the elaboration of more robust standards.

European Pharmacopoeia prepares for the future through exchange with stakeholders [homepage on the Internet].