Overview of assessment work - Priority list

Transcription

1 An agency of the European Union January 9 EMA/HMPC/7867/6 Committee on Herbal Medicinal Products (HMPC) Churchill Place Canary Wharf London E EU United Kingdom Telephone + () 66 6 Facsimile + () 66 Send a question via our website Overview of assessment work - Priority list Last update: January 9 Summary: Status Final monographs (Total) F 6 8 Finalised List entries (sent to Eur. Com.) F Final Public statements F n/a Assessment close to finalisation PF n/a Draft published P n/a Draft under discussion D Call for scientific data C Rapporteur assigned R n/a Assessment cancelled due to insufficient data n/a n/a R: Rapporteur assigned, C: Call for scientific data, D: Draft under discussion, P: Draft published, PF: Assessment close to finalisation (pre-final), F: Final opinion, : Assessment work cancelled due to insufficient data Review of new information to decide on a necessary update of monographs/ list entries is initiated by time elapsed since the previous published version (Periodic review after at least years) or by data submitted to HMPC (Unscheduled review) in accordance with Procedure for the review and revision of EU herbal monographs and list entries (EMA/HMPC/69/ Rev. ). The review step before revision was introduced in 8. The outcome of the review is: (I) yes, revision is needed because of new data of relevance for the content of the monograph or (II) no revision needed. For (I) the revision procedure is started ending with a new opinion on a revised monograph/ list entry and supporting documents. Previous documents are marked as superseeded but remain on the EMA website. For (II) a summary of new data is published as an Addendum to the existing assessment report. Monograph and all supporting documents remain unchanged. HMPC assessment outcome (MO: monograph, LE: list entry, PS: public statement) HMPC monograph for traditional use (TU), well-established use (WEU) or both Date and outcome of the decision on revision /9

2 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Absinthii herba // F 6/7/9 MO TU /7/ F //7 MO TU Adhatodae vasicae folium /7/ F 9/7/ PS //8 D Agni casti fructus 7/9/7 F // MO TU WEU 9/9/ F 7//8 MO TU WEU Agrimoniae herba //8 F 8// MO TU Agropyri repentis rhizoma //8 F // MO TU R Allii cepae bulbus // F 7// PS Allii sativi bulbus // F 8/7/7 MO TU Aloe // F 7/9/6 MO WEU // F //6 MO WEU Althaeae radix 7/9/6 F //9 MO TU // F /7/6 MO TU Andrographidis paniculatae folium 7// F 7/9/ PS //8 D //9 Angelicae sinensis radix // F 9/7/ PS //8 C Anisi aetheroleum // F /7/7 MO TU /7/ F // MO TU Anisi fructus // F /7/7 LE MO TU /7/ F // Arctii folium (Bardanae folium) 6//8 /9 6//9 C LE (not revised) MO TU Arctii radix 6//8 F 6/9/ MO TU Arnicae flos 7/9/7 F 6// MO TU Avenae fructus /7/6 F /9/8 MO TU //6 F 7//8 No Avenae herba /7/6 F /9/8 MO TU //6 F 7//8 No Balsamum peruvianum 8// F //6 PS Betulae folium // F 8//8 MO TU // F // MO TU Boldi folium // F //9 MO TU //6 F //6 MO TU Bursae pastoris herba 6//8 F /7/ MO TU //8 F 9//9 No Calendulae flos // F 6//8 LE MO TU // F 7//8 LE(not revised) MO TU Calendulae herba 8// D Camelliae sinensis non fermentatum folium // F // MO TU Capsici fructus // F // MO WEU Carvi aetheroleum 6//8 F 7/7/ MO TU Carvi fructus // F 7/7/ MO TU Caryophylii floris aetheroleum /7/ F /9/ MO TU Caryophylii flos //9 F // PS Centaurii herba // F //9 MO TU // F // MO TU Centellae asiaticae herba 8//8 F // PS //8 D Chamomillae romanae flos 6/7/9 F // MO TU R /9

3 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Chelidonii herba 6//8 F /9/ PS Cichorii intybi radix //9 F // MO TU Cichorii intybi folium //9 Cichorii intybi planta tota //9 / / Cimicifugae rhizoma 7/9/6 F // MO WEU 9/9/ F 7//8 MO WEU Cinnamomi camphorae (folium/cortex) 8// 9/ Cinnamomi corticis aetheroleum //9 F // MO TU Cinnamomi cortex 6//8 F // MO TU Cisti cretici folium 8// D Citri bergami aetheroleum //9 F // PS Colae semen 6/7/9 F // MO TU R Crataegi folium cum flore /7/7 F //6 MO TU Crataegi fructus /7/7 / Cucurbitae semen //8 F // MO TU Curcumae longae rhizoma // F //9 MO TU /7/ F /9/8 MO TU Curcumae xanthorrhizae rhizoma 6//8 F 8// MO TU Cyani flos 8// / Cynarae folium /7/6 F /9/ MO TU 9/9/ F 7//8 MO TU Echinaceae angustifoliae radix /7/6 F 7// MO TU //8 F //8 No Echinaceae pallidae radix /7/6 F 6/7/9 MO TU 9/9/ F /6/8 MO TU Echinaceae purpureae herba // F 6//8 LE MO TU WEU // F // LE (Not revised) MO TU WEU Echinaceae purpureae radix /7/6 F // MO TU 9/9/ F //7 MO TU Eleutherococci radix // F 8//8 LE MO TU // F // LE MO TU Epilobii herba 8// F // MO TU Equiseti herba /7/6 F /7/8 MO TU /7/ F //6 MO TU Eschscholziae herba // F 8// MO TU Eucalypti aetheroleum 7/9/7 F // MO TU Eucalypti folium 7/9/7 F // MO TU Euphrasiae herba 6//8 F 6/9/ PS Filipendulae ulmariae flos 6//8 F /7/ MO TU //8 C Filipendulae ulmariae herba 6//8 F /7/ MO TU //8 C Foeniculi amari fructus // F /7/7 LE MO TU // D /9

4 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Foeniculi amari fructus aetheroleum // F /7/7 MO TU // D Foeniculi dulcis fructus // F /7/7 LE MO TU // D Fragariae folium //8 F //8 MO TU Frangulae cortex // F 7/9/6 MO WEU // F MO TU WEU Fraxini folium 6/7/9 F 7// MO TU Fucus vesiculosus /9/ F 6// MO TU Fumariae herba // F /9/ MO TU Gentianae radix 7/9/7 F //9 MO TU /7/ F //8 MO TU Ginkgo folium 7/9/7 F 8// MO TU WEU Ginseng radix 7/9/7 F // MO TU Glycini semen 8// F /6/8 PS Grindeliae herba // F // MO TU R Hamamelidis cortex // F //9 MO TU //8 D //9 Hamamelidis folium // F //9 MO TU //8 D //9 Hamamelidis folium et cortex aut ramunculus destillatum // F //9 LE MO TU //8 D //9 Harpagophyti radix // F 6//8 MO TU 8// F /7/6 MO TU Hederae helicis folium 7/9/7 F // MO TU WEU /7/ F // MO WEU Helichrysi flos 8// F //6 MO TU Herniariae herba //8 D Hippocastani cortex 6// F // MO TU R Hyoscyami herba // / Hippocastani semen 7/9/6 F 6/7/9 MO TU WEU 9/9/ F /6/8 yes 9/9/ D Hyperici herba 6//6 F //9 MO TU WEU 8// PF Juglandis folium //8 F 9/7/ MO TU Juniperi aetheroleum 7/9/9 F // MO TU 6//9 C Juniperi communis summitates 8// 7/ Juniperi pseudo-fructus 6//8 F //9 MO TU 6//9 C Lavandulae aetheroleum //9 F 7// MO TU Lavandulae flos //9 F 7// MO TU Lecithinum ex soya 8// F //7 MO TU Leonuri cardiacae herba 7/9/9 F 6/9/ MO TU //8 F 6//9 No Levistici radix //8 F // MO TU 9/9/ F MO WEU /9

5 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Lichen islandicus // F // MO TU Lini semen 7// F /7/6 MO TU WEU /7/ F // MO TU WEU Liquiritiae radix /7/8 F // MO TU Lupuli flos // F 8//8 MO TU // F 6// MO TU Malvae sylvestris flos 9/9/ F //8 MO TU Malvae folium 9/9/ F //8 MO TU Marrubii herba 7/9/7 F 9/7/ MO TU Mate folium 7/9/7 F 6// MO TU //8 C Matricariae aetheroleum 7/9/7 F 7/7/ MO TU Matricariae flos 7/9/7 F 7/7/ MO TU Melaleucae alternifoliae aetheroleum 6//8 F // LE MO TU Meliloti herba // F /7/8 MO TU 6// F //7 MO TU Melissae folium // F //7 MO TU /7/ F // MO TU Menthae piperitae aetheroleum // F //7 LE MO TU // D #REF! Menthae piperitae folium // F /9/8 MO TU // PF MO TU Menyanthes trifoliata folium //8 D Millefolii flos //8 F /7/ MO TU 9/9/ F 6//9 No 9/9/ D Millefolii herba //8 F /7/ MO TU 9/9/ D //9 9/9/ D Myrrha (Commiphora molmol) 6//8 F /7/ MO TU //6 F /7/8 No Myrtilli folium 6/7/9 / Myrtilli fructus siccus //8 F 9/9/ MO TU Myrtilli fructus recens /7/ F 9/9/ MO TU Oenotherae biennis oleum 6//8 F // MO TU //6 F /6/8 MO TU Oleae folium //8 F // MO TU 9/9/ F //7 MO TU Ononidis radix // F // MO TU Origani dictamni herba /7/ F 9/7/ MO TU Origani majoranae herba 8// F /9/6 MO TU Orthosiphonis folium //8 F // MO TU 6//9 C Paeoniae radix rubra 8// F //7 PS Paeoniae radix alba 8// F //7 PS Paulliniae semen // F // MO TU Passiflorae herba // F 7/9/7 MO TU /7/ F // MO TU Pelargonii radix 6/7/9 F // MO TU /7/ F /6/8 MO TU /9

6 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Phaseoli fructus (sine semine) /9/ F // MO TU //8 F //9 No Picrorhizae kurroae rhizoma /7/ F 8// PS Pilosellae herba cum radice // F // MO TU Piperis methystici rhizoma // F //7 PS Pistacia lentiscus, resinum (mastix) 8// F //6 MO TU Plantaginis lanceolatae folium 7/9/7 F // MO TU Plantaginis ovatae semen // F /7/6 MO WEU /7/ F // MO WEU Plantaginis ovatae seminis tegumentum Polygalae radix // // F /7/6 MO WEU /7/ F // MO WEU 9/7 Polygoni avicularis herba 8// F //6 MO TU Polypodii rhizoma 8//7 F 6//8 MO TU //6 F /6/8 No Primulae flos /7/6 F 7/9/7 MO TU /7/ F /9/ MO TU Primulae radix // F 7/9/7 MO TU /7/ F /9/ MO TU Pruni africanae cortex /7/ F /7/6 MO TU Pruni spinosae flos /7/ Pruni spinosae summitates /7/ / / Psyllii semen // F /7/6 MO WEU 6/9/ F // MO WEU Quercus cortex //8 F // MO TU //8 D Rhamni purshianae cortex // F 7/9/7 MO TU WEU // D Rhei radix // F //7 MO WEU // D Rhodiolae roseae rhizoma et radix 6/7/9 F 7// MO TU Ribis nigri folium // F 6// MO TU //6 F 9/9/7 MO TU Ricini oleum 8// F //6 MO WEU Rosae aetheroleum /7/ / Rosae flos /7/ F /7/ MO TU Rosmarini aetheroleum //9 F /7/ MO TU 6//9 C Rosmarini folium 7/9/7 F /7/ MO TU 6//9 C Rubi idaei folium /9/ F 8// MO TU Rusci aculeati rhizoma /7/6 F /9/8 MO TU //6 F //8 MO TU Sabalis serrulatae fructus 7/9/7 F // MO TU WEU Saccharomyces cerevisiae CBS 96 8// D Salicis cortex // F //9 MO TU WEU // F //7 MO TU WEU Salviae officinalis aetheroleum 7/9/9 F /7/ PS // F Corr. //6 PS 6/9

7 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Salviae officinalis folium 8//7 F //9 MO TU // F /9/6 MO TU Salviae fruticosae folium 8// F //6 PS Salviae mitiorrhizae radix et rhizoma //8 C Sambuci flos 8//7 F /7/8 MO TU //6 F 7//8 MO TU Sambuci fructus /9/ F 8// PS Sennae folium // F /7/6 MO WEU // F /9/8 MO WEU Sennae fructus // F /7/6 MO WEU // F /9/8 MO WEU Sideritis herba 8// F //6 LE MO TU Silybi mariani fructus // F /6/8 MO TU Sisymbrii officinalis herba 7// F /9/ MO TU Soiae oleum raffinatum 7// F //7 MO TU Solani dulcamarae stipites 8// F // MO TU Solidaginis virgaureae herba 6//8 F /9/8 MO TU //8 D Species amarae 9//7 D Species digestivae or species stomachicae 9//7 D Species diureticae // F 8//7 MO TU Species sedativae 9//7 D Symphyti radix 8//8 F // MO TU Tanaceti parthenii herba 8//8 F // MO TU //6 D Taraxaci folium 6//8 F //9 MO TU 6//9 C R Taraxaci radix cum herba 7/9/7 F //9 MO TU 6//9 C R Terebinthinae laricina //9 / Thymi aetheroleum 7/9/7 F 6/9/ LE MO TU //6 D Thymi herba // F //7 MO TU // F // MO TU Thymi herba/ Primulae radix 7/9/7 F /9/ MO TU /7/ F //6 MO TU WEU Tiliae flos // F // MO TU Tiliae tomentosae flos // F // PS Tormentillae rhizoma /7/8 F // MO TU //8 F 6//9 No Trigonellae foenugraeci semen //8 F 7// MO TU //6 F /7/8 Yes D Uncariae tomentosae cortex 6/7/ F // PS Urticae folium // F // MO TU R Urticae herba // F /9/8 MO TU R Urticae radix // F /9/ MO TU R 7/9

8 Herbal substance Prioritised Status Opinion Outcome Outcome Prioritised Status Decision on revision Prioritised Status Opinion Outcome Outcome Uvae ursi folium // F // MO TU /7/ F // MO TU Vaccinii macrocarpi fructus 9/9/ D Valerianae aetheroleum 7// (part of radix) 9/9/ F MO TU (part of radix) /7/ F //6 MO TU Valerianae radix 7// F /7/6 MO TU WEU /7/ F //6 LE MO TU WEU Valerianae radix/lupuli flos //7 F 6// MO TU WEU 9/9/ PF MO TU WEU Verbasci flos 8//7 F /7/8 MO TU //6 F 7//8 MO TU Verbenae citriodorae folium //8 D Violae tricoloris herba //8 F // MO TU Visci albi herba //9 F // PS Vitis viniferae folium //8 F /7/ Corr. // Withaniae somniferae radix /7/ F 9/7/ PS Zingiberis rhizoma // F 7// MO TU WEU LE MO TU WEU //8 D 9/9/ F //7 LE (not revised) MO TU WEU 8/9

9 Last update: January HMPC Rapporteur Distribution Finalised First Assessments Rapporteur Peer review HMPC Rapporteur Distribution Finalised s Rapporteur Peer review 9/9