Nyheter inom Europafarmakopén Torbjörn Arvidsson, Läkemedelsverket
9 th Edition European Pharmacopeia 2687 texts (2329 monographs + 358 general texts) About 2600 descriptions of reagents Total ca 3500 pages
Monograph distribution Källa: EDQM
Regulatory legislation, quality of medicines Annex I of EU directive 2001/83/EC, as amended Scientific guidelines (EMA) should be taken into account in assembling the dossier for application for market authorisation Monographs, general monographs and general chapters of the European Pharmacopeia are applicable Manufacturing process should apply to GMP
Quality of medicines in Europe European Authorities National Authorities Licensing Inspection OMCL European Union Council and Parliament Commission Sanco Brussels European Medicines Agency (EMA) London Certification Pharmacopoeal Secreteriat European Pharmacopeia European Directorate for the Quality of medicines and health care (EDQM) Strasbourg Council of Europe OMCL Network Pharmaceuticals/ Pharmaceutical care Conumer health protection
Källa: EDQM
European Pharmacopeia work in expert groups and working parties (ca 20+35) public consultation of text published in Pharmeuropa decisions taken by European Pharmacopeia Commission adopted texts published in European Pharmacopeia
Co-operation and committed experts needed 720 experts from the Ph. Eur. members states and observers in 20 permanent expert groups and about 35 working parties Industry Regulators Academia In many groups lab resources is needed
Basis for monographs Monographs take account of all currently approved products Based on Approved specification(s) and backed up by batch data Draft monographs are checked by regulatory authorities at Pharmeuropa stage Policy for monograph development is given in: Technical Guide for the Elaboration of Monographs https://www.edqm.eu/sites/default/files/technical_guide_for_the_elaboration_of_monographs_7th_edition_2015.pdf
Revision of monographs Need to update the monographs New sources approved in Europe Changes in route of synthesis of approved products New regulations (e.g. ICH M7, ICH Q3D, REACH) New technologies Pharmacopoeial harmonisation
Edqm.eu
2016 valår för alla experter och kommissionsordföranden Europafarmakopékommissionen: Ordförande: Tobias Godschan, Schweiz 1:a vice ordf.: Torbjörn Arvidsson, Sverige 2:a vice ordf. Hilda Kuszegine-Szalai, Ungern 36 st svenska experter Svenska ordföranden: Sven Erik Hillver - Standard terms Robert Burman - Pyrrolizidine alkaloids Torbjörn Arvidsson - 10A
Nyheter de senaste 2 åren Substances for pharmaceutical use uppdaterad Elemental impurities ICH Q3D Genotoxic impurities ICHM7 Acceptable Intakes for an Individual Impurity
Genotoxic impurities Kan finnas antingen under Tests eller i Production session Specifikt test om kända gränser Om sofistikerade metoder används eller om det inte finns lämplig metod så finns beskrivningen i Production session
News: April 2017
Konferenser och workshops Konferens om referensstandarder, April 2016, Kvalitetskrav för fiskvacciner, Oslo, maj 2016 Workshop International regulatory meeting om utredningar av generika för myndigheter, en dag av mötet var öppen för industrin, Maj 2016 Joint EDQM/EMA event on Biosimilars 8 th February 2017, Strasbourg, France Conference on the place of the Certification Procedure in the global regulatory environment, 19-20 September, Prag What s up with microbiology? Recent developments and future changes at the Ph. Eur. Symposium, 10-11 October, Strasbourg
Konferens för att introducera 9 TH Edition "European Pharmacopoeia: Tackling future challenges of the Quality of Medicines together", (27-28 September 2016, Tallinn, Estonia) 350 deltagare Program: Setting Pharmacopoeial Standards for Bioterapeutic Products Control of Elemental Impurities New Technologies Excipients, other components and International Harmonisation
Webinars 2016: technical guide finished products monographs 2017: Elemental Impurities : Implementation of ICH Q3D, 17 January and 16 May Water for Injections 1 April (only open to regulatory agency participants) Raw Materials of biological origin for the Production of Cell-based and Gene Therapy Medicinal Products, 9 November (200 participants from 34 countries) How to get acceptance of CEP revisions quickly 13 November (700 participants from 52 countries)
Nya och reviderade monografier Nya: 66 st nya monografier/texter antagna under de två senaste åren EDQM:s hemsida press release efter varje kommissionsmöte Revisioner: Substances for Pharmaceutical use ICHQ3D, ICHM7, endotoxiner Water for injection tillåter omvänd osmos Test for abnormal toxicity har tagits bort, revision av 85 monografier,49 (kemi), 36 (human vacciner) Referensstandarder:
New trends assay A trend in industry is to perform assay using liquid chromatography In the European Pharmacopeia now a number of assays using titration have been replaced by liquid chromatography
New trends in test of related substances Liquid chromatographic methods with high selectivity introduced Core shell columns (can be used in any LC-system) UPLC columns 0.050 0.045 0.040 0.035 0.030 Paracetamol - 3.473 Impurities of Paracetamol 0.025 AU 0.020 0.015 0.010 0.005 0.000 1.115 Imp K - 1.369 2.403 Imp A - 7.938 Imp B - 8.922 Imp F - 10.675 Imp C - 11.430 Imp D - 13.162 Imp E - 14.423 Imp M - 17.982 Imp G - 18.608 Imp H - 26.046 Imp L - 29.129 32.797 Imp I - 33.686 34.604 Imp J - 35.467 Imp N - 42.086-0.005-0.010 0.00 2.00 4.00 6.00 8.00 10.00 12.00 14.00 16.00 18.00 20.00 22.00 24.00 26.00 28.00 30.00 32.00 34.00 36.00 38.00 40.00 42.00 44.00 46.00 48.00 50.00 Minutes
Future trends; New technologies New analytical techniques are introduced in the Method chapters Techniques that are likely to be used in a higher extent in the future UPLC LC/MS/MS NMR Chemometrics
Pharmacopoeial discussion group (PDG) The Pharmacopoeial Discussion Group (PDG) European Pharmacopoeia (Ph.Eur.) Japanese Pharmacopoeia (JP) United States Pharmacopoeia (USP) Harmoniserade texter publiceras i Kapitel 5.8 i Europafarmakopén Arbetsprocesser ses över för att effektivisera arbetet
LC and GC kolonner i monografier Beskrivning av stationära faser inom välskekromatografi har uppdaterats Bara namn på reagents har ändrats I monografierna, Kolonnerna som listas i Knowledge Database och analysmetoderna har inte ändrats Ändringarna göra succesivt och publiceras med varje nytt supplement En liknande genomgång kommer att göras för gaskromatografi och beräknas publiceras i 10th Edition, (Juli 2019).
Aktuella frågeställningar inom europafamakopén Co-processed exipients WP MG revision av metoder Histamine i substanser som tillverkas från fiskråvara (gentamicin) Finished products monographs