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Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European P

Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European Pharmacopoeia. Dr Claude Coune Head of the Publication and IT division. 4 procedures. Procedure 1: group of experts Procedure 2: adaptation of existing national monograph

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Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European P

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  1. Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European Pharmacopoeia Dr Claude Coune Head of the Publication and IT division

  2. 4 procedures • Procedure 1: group of experts • Procedure 2: adaptation of existing national monograph • Procedure 3: direct co-operation with innovator, work co-ordinated by national pharmacopoeia • Procedure 4: direct co-operation with innovator, work co-ordinated by EDQM

  3. Stages in elaboration • All four procedures : • Addition to work programme by Commission: public announcement (industry associations, Pharmeuropa, web site) • Interested parties can (and should!) express an interest • Elaboration, experimental checking of draft • Publication in Pharmeuropa (3-month comment period)

  4. Stages in elaboration (2) • Study of comments by group of experts/working party • Submission to Commission for adoption • Publication within 6 months • Implementation 1 year after adoption • Overall timescale: minimum 2-3 years

  5. Work status • Key to information on status: 0 = on the work programme, no first draft 1 = first draft (new or revised monograph) 2 = published (or in press) in Pharmeuropa 3 = submitted to the Commission 4 = adopted, ready for publication 5 = published

  6. Work programme • Based on proposals from: • National delegations • Groups of experts • EDQM • Manufacturers can submit proposals via one of the above

  7. Work programme (2) • Additions announced on web site • Search engine at www.pheur.org for complete work programme • Communication via industry associations

  8. New monographs: actives • For active substances, aim is to have monograph ≥ 2 years before patent expiry • Addition to programme depends on: • therapeutic importance • extent of use • number of countries in which product is approved • known quality problems

  9. New monographs: excipients • For excipients, important criteria are: • extent of use • type of use (parenteral, oral, etc) • number of preparations in which the excipient is used • known quality problems

  10. How to participate • Participation depends on the procedure used • For all procedures it is in your interest to provide samples for testing • Information on actives and excipients in approved products is needed

  11. Procedure 1 • Declare an interest in the monograph being elaborated or revised • Indicate willingness to provide samples and to work with the group • EDQM will organise contact with co-ordinator for the monograph

  12. Direct participation • Join a group of experts: contact your national pharmacopoeia authority, which makes proposals for experts • Work as a co-opted expert for a particular project that is of interest: short-term commitment

  13. Procedures 3 & 4 • EDQM contacts the innovator to determine willingness to work on monograph • Close co-operation during elaboration • Will be used systematically for single-source products in future

  14. Proposing a new monograph • Contact your National Pharmacopoeia Authority (in Europe) or EDQM (outside Europe) • Initial data: countries where the product is approved • Data package: • Current specification • Validation reports • Samples of substances and impurities • Full description of data package is available

  15. Pharmacopoeia liaison • EDQM wishes to have a pharmacopoeia liaison contact for each major manufacturer/user • Channel information and requests from manufacturer to EDQM • Reception point for contact by EDQM • Benefits for both sides

  16. Revision • Types of revision: • Correction of a monograph/general chapter • Minor revision • Routine revision • Rapid revision

  17. Corrections • Correction of obvious errors (typos, etc.) • Dealt with by Secretariat, notification to Commission and national authorities • No Pharmeuropa publication • Effective from the official publication date of the edition/supplement • Occasionally used for rapid implementation of a true revision

  18. Minor revision • Minor technical changes that do not need to be published for consultation in Pharmeuropa • Adopted by Commission on the basis of a briefing note • Implemented with other revisions in next edition/supplement

  19. Routine revision • Based on request for revision with sufficient data • Studied by group of experts • Published in Pharmeuropa • Adopted by Commission • Implemented in next edition/supplement

  20. Rapid revision • Special procedure intended for use where there is a serious public health concern • Cumbersome (publication of resolution and in official journal of each Member State) and not very rapid • Rarely used nowadays, “correction” preferred (faster and simpler)

  21. Revision programme • Work programme is announced via web site • Declare an interest for relevant items • Make sure you see Pharmeuropa for revision proposals • Provide samples, test draft proposal

  22. Revision: why? • New sources have new impurity profiles • Quality improves, monograph should keep in line • New quality issues arise • Analytical methods change: more convenient methods, more powerful methods, more reliable methods become available • International harmonisation (PDG, ICH, VICH)

  23. Revision: why? (2) • FAQ: “Why did you revise the monograph on…?” • You can find out via: • Briefing notes in Pharmeuropa • Collected briefing notes posted on the web site for each new edition/supplement • There is no briefing note for corrections

  24. How to request revision • Commission decides on revision • Based on proposals from: • National delegations • Groups of experts • EDQM • Manufacturers should submit via one of these

  25. How to request revision (2) • Europe: via national pharmacopoeia authority (address list in Pharmeuropa) • Outside Europe: contact EDQM which will refer the matter to a group of experts or to the Commission • Make clear what needs revising and if possible make a concrete proposal

  26. Data for revision • Revision can only be undertaken if the request is backed up by sufficient data • Give batch data, sample chromatograms, etc. to enable a decision on the need for revision

  27. Special revision programme • Instituted in 2004 to replace TLC by quantitative methods in about 140 monographs on APIs • Phase 1: 2004-6, 40 monographs on APIs + 20 amino acids • Manufacturers invited to submit data • Information available on web site

  28. Traditional Medicines • 50 Chinese Traditional Medicines (herbals), • About 15 published, or about to be published • Other traditions: Indian (?), South America

  29. Knowledge database • The whole programme of the European Pharmacopoeia • All published monographs • All monographs under elaboration • All monographs accepted for elaboration • Links to the catalogue of reference standards • Links to the Certification database • Additional information

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