Melissa leaf Human plasma pooled and treated for virus inactivation Mullein flower Human prothrombin complex Nettle leaf Human von Willebrand factor Oregano Hydrocortisone Peppermint leaf Insulin, human Red poppy petals Ioxaglic acid 1 This text entered into force on 1 August These corrections are to be taken into account from the publication date of the 7th Edition 15 July General notices radiopharmaceutical preparations Ammonia 13N injection Chromium 51Cr edetate injection 2. Bacterial endotoxins Cyanocobalamin 57Co capsules 2. Microbiological assay of antibiotics Cyanocobalamin 57Co solution 2. Materials based on plasticised poly vinyl chloride for Fludeoxyglucose 18F injection containers for human blood and blood components Gallium 67Ga citrate injection 3.
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The 7 th Edition is thus published just after the 45 th anniversary of the start of the European Pharmacopoeia and the 60 th anniversary of the Council of Europe. The 3-year cycle of publication with thrice-yearly supplements has proven to be an efficient way to publish and update the results of the work of the European Pharmacopoeia Commission, its Expert Groups and Working Parties almost in real time. The monographs of the Pharmacopoeia, both specific and general, together with other texts made mandatory by virtue of reference in monographs, are applicable throughout the 36 Member States and the European Union itself, which is also a signatory party to the European Pharmacopoeia Convention.
Consequently, the quality standards developed through the European Pharmacopoeia have an impact on the quality of medicinal products and substances used in the production of medicines across a large part of the globe. The Pharmacopoeia is published in the 2 official languages of the Council of Europe, i.
English and French, as a printed version and electronically in addition to the online version, the 7 th Edition is the first one to be made available on a USB key in order to be more user-friendly than the previous DVD version. It is noteworthy that certain member states undertake national or regional translations, e. The 7 th Edition will become effective on 1 January , and will, over the next 3 years, be augmented with 8 supplements containing the texts adopted at the meetings of the European Pharmacopoeia Commission 3 per year.
The work programme of the European Pharmacopoeia is decided by the Commission. The members of these groups come from regulatory authorities, official medicines control laboratories, pharmaceutical and chemical manufacturers, universities and research institutions.
All monographs are experimentally verified and submitted for public consultation by publication in Pharmeuropa , the quarterly forum of the European Directorate for the Quality of Medicines and HealthCare EDQM , before adoption and publication in the European Pharmacopoeia.
The growing number of monographs and the need to keep them updated represents an increase in workload and an increased need for experts with access to experimental facilities. The working procedures for the elaboration of monographs are : — Procedure 1 : the traditional elaboration by Groups of Experts and Working Parties; — Procedure 2 : adaptation of national monographs; — Procedure 3 : applying to chemical substances produced by only one manu facturer, usually close to patent expiry.
In this procedure, the manufacturer and national pharmacopoeia authority in the country where the substance is produced carry out preliminary drafting stages and check the requirements experimentally. The draft is then reviewed by a Group of Experts or Working Party and processed in the usual way by public enquiry; — Procedure 4 : a modified version of Procedure 3 for substances still under patent, which was introduced by the Commission in From the 6 th Edition onwards, the processes used for the elaboration of monographs are P1 and P4, since the processes of adaptation of national monographs P2 and Procedure 3 have been largely exhausted.
Following the success of the P4 procedure for chemical substances, in the Commission decided to start a similar one for biological substances. The so called P4-bio procedure takes account of the increasing number and importance of biologically derived active substances and biosimilars on the European market. The 8 founder countries of the Convention realised in that manufacturing and quality control standards for medicinal products on the European Market had to be harmonised for reasons of public health and to facilitate free movement of these products.
Since then, the pharmaceutical world has changed into a global one and international harmonisation among the 3 major pharmacopoeias European Pharmacopoeia, Japanese Pharmacopoeia and United States Pharmacopeia was a logical further development. Harmonisation activities among these 3 pharmacopoeias started in when the Pharmacopoeial Discussion Group PDG was set up.
The PDG has worked on monographs of widely used excipients and about 60 are currently included on the work programme. Soon after the PDG started work it was recognised that the absence of harmonised general methods represented a large obstacle. A wide range of general methods was added to the work programme, including those from the work of the International Conference on Harmonisation ICH and in particular its guideline on setting specifications Q6A.
Detailed information on the work programme of the PDG is published in Pharmeuropa and in general chapter 5. Pharmacopoeial harmonisation. For the European Pharmacopoeia, a number of important activities were started in the last few years, including: a special revision programme of monographs to modernise impurity testing in older monographs; the development of sections on functionality related characteristics for excipients; elaboration of monographs on traditional herbal medicines especially Chinese ones ; elaboration of monographs and chapters on homoeopathic medicinal products making use of existing homoeopathic pharmacopoeias in Europe.
A lot of progress has been made, as can be seen in this 7 th Edition, however the work is not finished and needs to be continued with vigour. A special challenge the European Pharmacopoeia Commission found i tself faced with was the heparin incident in , which required an immediate revision of the respective monographs in order to render them capable of controlling a contaminant introduced by criminal minds in a situation of shortage of the correct starting material.
During the past 3 years I have had the honour, pleasure and privilege to serve the European Pharmacopoeia Commission as its 15 th elected Chair.
I want to thank all members of the Commission for the trust and support that allowed us to make good progress.
In this period we lost Mr Peter Castle, Secretary to the Commission, who passed away after having battled against his illness with determination, dignity and great courage. In the 34 years he spent with the European Pharmacopoeia, he had a significant impact on the development and success of the European Pharmacopoeia and in international harmonisation and he is dearly missed by all of us.
Their availability, good advice and high quality input have made our work possible and a pleasure to do. Dr Henk J. It is composed of delegations appointed by the Contracting Parties. Each delegation consists of not more than 3 members chosen for their competence in matters within the functions of the Commission. Observers from non-Member States and international organisations are admitted to Sessions of the Commission in accordance with the Rules of Procedures.
The Convention is open for signature by European countries and observer status can serve to familiarise European countries intending to become signatories with the working methods of the Commission. The Commission recognises that relations with countries outside Europe are essential in view of the globalisation of the supply chain for pharmaceuticals. Observer status for non-European countries helps to foster these relations by facilitating regulatory partnerships and the exchange of information and working documents.
2010. EP 7th Edition Volume 1
The pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into appropriate legislation. Further explanation or the role of The International Pharmacopoeia is provided in the paragraphs entitled "Scope and function" at the end of the Preface of this edition. The history of The International Pharmacopoeia dates back to when the need to standardize terminology and to specify dosages and composition of medicines led to this international pharmacopoeial compendium. Compared to other pharmacopoeias, priority is given to medicines included in the WHO Model List of Essential Medicines and to medicines which are important for WHO health programmes and for which other pharmacopoeias do not offer any test specifications. The quality control specifications published in The International Pharmacopoeia are developed independently via an international consultative procedure. The needs of developing countries are taken into account.
European Pharmacopoeia (Ph. Eur.) 10th Edition
European Pharmacopoeia 7.0 - 2011