Call For Submission Of Scientific Data Relating To The Assessment Of Centellae Asiaticae Herba Centella Asiatica (L.) Urban, Herba (Centella)

European Medicines Agency Evaluation of Medicines for Human Use

London, 15 September 2008 Doc Ref.: EMEA/HMPC/464551/2008




Centellae asiaticae herba Centella asiatica (L.) Urban, herba (Centella)



The Committee on Herbal Medicinal Products (HMPC) was established in September 2004, in accordance with Regulation (EC) No 726/2004. The duties of HMPC are laid down in Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC. They aim at enhancing the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework.

The establishment of Community herbal monographs as well as a draft Community ‘list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’ are among the core duties of the HMPC. Public calls for submission of relevant scientific data represent an important part of the HMPC’s efforts to obtain the best possible basis for the related assessment work.

Call for scientific data

The HMPC invites all interested parties1 to submit any scientific data, which may be used in the assessment of Centellae asiaticae herba as part of the establishment of Community herbal monographs, and/or entries to the Community ‘list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products’.

The Rapporteur is seeking to receive copies of scientific contributions other than those referred to in the annex to this call for submission of scientific data.

1 Such as pharmaceutical industry associations, health care professional groups, learned societies, consumers and patients’ associations, governmental institutions as well as EU and EEA-EFTA Member States.

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 70 51 E-mail: © European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged

Conditions for data submissions

Scientific contributions should be relevant to the purpose of the assessment, and their scope should address either:

1.    Well-established medicinal use: Submitted data should provide evidence that the constituent or the constituents of the medicinal product has or have a well-established medicinal use with recognised efficacy and an acceptable level of safety within the meaning of Directive 2001/83/EC as amended.

2.    Traditional use: Submitted data should provide evidence that the medicinal product in question, or a corresponding product, has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community.

Furthermore, the acceptance of scientific contributions will be based on compliance with the following general criteria:

1.    The name and contact details of the party providing the scientific contribution is required.

2.    Scientific contributions should be classified by the interested party as (i) peer-reviewed data; or (ii) non peer-reviewed data. The EMEA encourages submission of peer-reviewed data/publications (not just the reference) as the most relevant and reliable documents. Non peer-reviewed data such as references from older standard books of phytotherapy or comparable scientific sources can be taken into consideration provided that they are of an adequate quality.

3.    A document providing a specification of the literature search strategy, the date of the search, search terms (inclusion/exclusion terms) as well as a listing of databases used for the search should be enclosed.

4.    All contributions should be provided in either electronic format (e.g. via e-mail or a CD-Rom) or paper format (2 copies) and a list of attached documents and their references should be enclosed.

Non-compliance with any of these requirements for data submission may result in the rejection of the contribution provided.

To facilitate an effective handling of incoming documents and/or CD-Roms etc., interested parties are requested to submit documents:

either to the following email address: or by post:

European Medicines Agency (EMEA)

7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Att.: HMPC secretariat

or by fax: (44-20) 75 23 70 51, Att.: HMPC secretariat.

Please note, that in order for the Rapporteur to respect assessment deadlines, any submissions are kindly requested by 30 November 2008 at the latest.


The use by the HMPC of bibliographic material is entirely for a non-commercial purpose. As its noncommercial use by the Committee is guaranteed, any interested party will not incur in any liability as to the use intended by the HMPC by forwarding bibliographic literature to the Committee. The HMPC is in all cases willing to confirm in writing the non-commercial use of documents sent in by interested parties.


Unpublished data may be included. Confidentiality will be lifted in cases where the contributor has given its consent. In other cases where confidential data are presented, it should be duly justified why these data are protected and how transparency in the procedure of assessment can be assured. The HMPC will consider such submissions on a case-by-case basis. The contributor should also take duly into account the rights of interested parties, as the documentation provided will be used for the development of Community list entries and Community herbal monographs. Such development is underpinned by assessment reports, which will be made public in accordance with measures taken by the EMEA to ensure an appropriate level of transparency.

Language requirements

Documents should be submitted in English where possible since this is the working language of the HMPC, but documents in other official Community languages will be accepted. In order to facilitate the assessment, the HMPC strongly recommends the submission of an abstract in English when original references are provided.

List of references already acquired by the Rapporteur:

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20.    Cheng CL, Guo JS, Luk J, Koo MW. The healing effects of Centella extract and asiaticoside on acetic acid induced gastric ulcers in rats. Life Sci 2004, 74:2237-49

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26.    Edwin D, Geetha VR, Vishwanathan H, Usha Rani MV. Studies on antimutagenic effects of Centella asiatica, Alternanthera sessilis and Emblica officinalis in somatic cells of mice. J. Environ. Biol. 2000, 21:75-8

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28.    Gadahad MR, Rao M, Rao G. Enhancement of hippocampal CA3 neuronal dendritic arborization by Centella asiatica (Linn) fresh leaf extract treatment in adult rats. J Chin Med Assoc 2008, 71:6-13

29.    Gautam R, Saklani A, Jachak SM. Indian medicinal plants as a source of antimycobacterial agents. J Ethnopharmacol 2007, 110:200-34

30.    Gnanapragasam A, Ebenezar KK, Sathish V, Govindaraju P, Devaki T. Protective effect of Centella asiatica on antioxidant tissue defense system against adriamycin induced cardiomyopathy in rats. Life Sci 2004, 76:585-97

31.    Govindan G, Sambandan TG, Govindan M, Sinskey A, Vanessendelft J, Adenan I, et al. A bioactive polyacetylene compound isolated from Centella asiatica. Planta Med 2007, 73: 597-9

32.    Gupta YK, Veerendra Kumar MH, Srivastava AK. Effect of Centella asiatica on pentylenetetrazole-induced kindling, cognition and oxidative stress in rats. Pharmacol Biochem Behav 2003, 74:579-85

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34.    Herbert D, Paramasivan CN, Prabhakar R, Swaminathan G. In vitro experiments with Centella asiatica: investigation to elucidate the effect of an indigenously prepared powder of this plant on the acid-fastness and viability of M. tuberculosis. Indian J Lepr 1994, 66:65-8

35.    Hong SS, Kim JH, Li H, Shim CK. Advanced formulation and pharmacological activity of hydrogel of the titrated extract of Centella asiatica. Arch Pharm Res 2005, 28:502-8

36.    Huang YH, Zhang SH, Zhen RX, Xu XD, Zhen YS. [Asiaticoside inducing apoptosis of tumour cells and enhancing anti-tumour activity of vincristine.]. Ai Zheng 2004, 23:1599604

37.    Husain GM, Mishra D, Singh PN, Rao CV, Kumar V. Ethnopharmacological review of native traditional medicinal plants for brain disorders. Pharmacognosy Reviews 2007, 1:1928

38.    Hussin M, Abdul-Hamid A, Mohamad S, Saari N, Ismail M, Hair Bejo M. Protective effect of Centella asiatica extract and powder on oxidative stress in rats. Food Chemistry 2007, 100:535-41

39.    Inamdar PK, Yeole RD, Ghogare AB, de Souza NJ. Determination of biologically active constituents in Centella asiatica. Journal of Chromatography A 1996, 742:127-30

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41.    Jayashree G, Kurup Muraleedhara G, Sudarslal S, Jacob VB. Anti-oxidant activity of Centella asiatica on lymphoma-bearing mice. Fitoterapia 2003, 74:431-4

42.    Jayathirtha MG, Mishra SH. Preliminary immunomodulatory activities of methanol extracts of Eclipta alba and Centella asiatica. Phytomedicine 2004, 11:361-5

43.    Jia G, Lu X. Enrichment and purification of madecassoside and asiaticoside from Centella asiatica extracts with macroporous resins. J Chromatogr A 2008, 1193:136-41

44.    Jorge OA, Jorge AD. Hepatotoxicity associated with the ingestion of Centella asiatica. Rev Esp Enferm Dig 2005, 97:115-24

45.    Kavindra Nath Tiwari, Nilesh Chandra Sharma, Vaibhav Tiwari, Brahma Deo Singh. Micropropagation of Centella asiatica (L.), a valuable medicinal herb. Plant Cell, Tissue and Organ Culture 2000, 63:179-85

46.    Kim C, Hwang YY, Chang JY, Choi HG, Lim SJ, Lee MK. Development of a novel dosage form for intramuscular injection of titrated extract of Centella asiatica in a mixed micellar system. International Journal of Pharmaceutics 2001, 220:141-7

47.    Kim OT, Ahn JC, Hwang SJ, Hwang B. Cloning and expression of a farnesyl diphosphate synthase in Centella asiatica (L.) Urban. Mol Cells 2005, 19:294-9

48.    Kim OT, Bang KH, Shin YS, Lee MJ, Jung SJ, Hyun DY et al. Enhanced production of asiaticoside from hairy root cultures of Centella asiatica (L.) Urban elicited by methyl jasmonate. Plant Cell Rep 2007, 26:1941-9

49.    Kim OT, Kim MY, Hong MH, Ahn JC, Hwang B. Stimulation of asiaticoside accumulation in the whole plant cultures of Centella asiatica (L.) urban by elicitors. Plant Cell Rep 2004, 23:339-44

50.    Kim OT, Kim MY, Huh SM, Bai DG, Ahn JC, Hwang B. Cloning of a cDNA probably encoding oxidosqualene cyclase associated with asiaticoside biosynthesis from Centella asiatica (L.) Urban. Plant Cell Rep 2005, 24:304-11

51.    Kuroda M, Mimaki Y, Harada H, Sakagami H, Sashida Y. Five new triterpene glycosides from Centella asiatica. Nat. Med. 2001, 55:134-8

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53.    Lee J, Jung E, Kim Y, Park J, Park J, Hong S et al. Asiaticoside Induces Human Collagen I Synthesis through TGFp Receptor I Kinase (TpRI Kinase)-Independent Smad Signaling. Planta Med 2006, 72:324-8

54.    Liu M, Dai Y, Li Y, Luo Y, Huang F, Gong Z et al Madecassoside isolated from Centella asiatica herbs facilitates burn wound healing in mice. Planta Med 2008, 74:809-15

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62.    Mohandas Rao KG, Muddanna Rao S, Gurumadhva Rao S. Centella asiatica (L.) Leaf Extract Treatment During the Growth Spurt Period Enhances Hippocampal CA3 Neuronal Dendritic Arborization in Rats. Evid Based Complement Alternat Med 2006, 3:349-57

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