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Mei Wang - One of the best experts on this subject based on the ideXlab platform.

  • non european traditional herbal medicines in europe a community herbal Monograph perspective
    Journal of Ethnopharmacology, 2014
    Co-Authors: Wenjun Zou, Zhenxiang Zhou, Tingmo Zhang, Janvander Greef, Mei Wang
    Abstract:

    Abstract Ethnopharmacological relevance The European Directive 2004/24/EC introducing a simplified registration procedure for traditional herbal medicinal products, plays an important role in harmonising the current legislation framework for all herbal medicinal products in the European Union (EU). Although substantial achievements have been made under the new scheme, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Therefore, identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products are of critical importance for the EU herbal medicinal product market. Aims of the study The primary aims of this study were to understand the key issues and obstacles to registration of non-European traditional herbal medicinal products within the EU. The findings may identify the need for more attention on the Community herbal Monographs elaborated by the Herbal Medicinal Products Committee (HMPC), as well as further evidence based scientific research on non-European herbal substances/preparations by the scientific community. Methods A systematic evaluation of the herbal substances and preparations included in Community herbal Monographs and public statements has been carried out. The focus was herbal substances and preparations derived from non-European traditions. Results Of the 109 adopted Community herbal Monographs, 10 are herbal substances used in Chinese traditional medicine. Where the HMPC issued a public statement because it was unable to elaborate a Monograph more than half-involved herbal substances/preparations from non-European traditions. The main reasons herbal substances/preparations from non-European traditions were not accepted for inclusion in the Community herbal Monographs have been identified as due to unfulfilled requirements of Directive 2004/24/EC. The most common reasons were the lack of evidence to demonstrate a 15-year minimum medicinal use period in the EU and evidence of absence of health risk as required by Article 16a (1) (d), and Article 16a (1) (e). Conclusions Under the current EU legislation, the requirement to demonstrate 15-year minimum medicinal use in the EU is a major obstacle to the registration of non-European traditional herbal medicinal products. Access to scientific data to support the product safety profile may be a possible solution to overcome the hurdle presented by the 15-year minimum medicinal use period. Furthermore, the Community herbal Monographs play an important role in the registration process. Therefore, making full use of existing Community herbal Monographs, and promoting scientific research and subsequent development of additional Monographs for herbal substances and preparations, and combinations thereof from non-European traditions would be of benefit to herbal medicinal product registration from non-European traditions.

Dennis Massie - One of the best experts on this subject based on the ideXlab platform.

  • from traditional inter library loan to a new interlending model the role of the curl Monograph interlending pilot
    Interlending & Document Supply, 2002
    Co-Authors: Stephen Prowse, Dennis Massie
    Abstract:

    The traditional inter‐library loan of Monographs is often seen as the future niche of interlending activity, with journal article supply being catered for by other means, such as full text access through e‐journals. Examines how a Monograph interlending pilot project, undertaken by CURL institutions, is part of a move towards a more distributed interlending model for the UK. Describes the project, presents statistical figures, and outlines results from feedback questionnaires. Shows the relationship to SHARES, RLG’s interlending program, and how the pilot has affected international interlending. Calls for other models to support the new interlending paradigm.

  • from traditional inter library loan to a new interlending model the role of the curl Monograph interlending pilot
    Interlending & Document Supply, 2002
    Co-Authors: Stephen Prowse, Dennis Massie
    Abstract:

    The traditional inter‐library loan of Monographs is often seen as the future niche of interlending activity, with journal article supply being catered for by other means, such as full text access through e‐journals. Examines how a Monograph interlending pilot project, undertaken by CURL institutions, is part of a move towards a more distributed interlending model for the UK. Describes the project, presents statistical figures, and outlines results from feedback questionnaires. Shows the relationship to SHARES, RLG’s interlending program, and how the pilot has affected international interlending. Calls for other models to support the new interlending paradigm.

Wenjun Zou - One of the best experts on this subject based on the ideXlab platform.

  • non european traditional herbal medicines in europe a community herbal Monograph perspective
    Journal of Ethnopharmacology, 2014
    Co-Authors: Wenjun Zou, Zhenxiang Zhou, Tingmo Zhang, Janvander Greef, Mei Wang
    Abstract:

    Abstract Ethnopharmacological relevance The European Directive 2004/24/EC introducing a simplified registration procedure for traditional herbal medicinal products, plays an important role in harmonising the current legislation framework for all herbal medicinal products in the European Union (EU). Although substantial achievements have been made under the new scheme, only a limited number of herbal medicinal products from non-European traditions commonly used in Europe have been registered. Therefore, identification of the obstacles, and determination of appropriate means to overcome the major challenges in the registration of non-European traditional herbal medicinal products are of critical importance for the EU herbal medicinal product market. Aims of the study The primary aims of this study were to understand the key issues and obstacles to registration of non-European traditional herbal medicinal products within the EU. The findings may identify the need for more attention on the Community herbal Monographs elaborated by the Herbal Medicinal Products Committee (HMPC), as well as further evidence based scientific research on non-European herbal substances/preparations by the scientific community. Methods A systematic evaluation of the herbal substances and preparations included in Community herbal Monographs and public statements has been carried out. The focus was herbal substances and preparations derived from non-European traditions. Results Of the 109 adopted Community herbal Monographs, 10 are herbal substances used in Chinese traditional medicine. Where the HMPC issued a public statement because it was unable to elaborate a Monograph more than half-involved herbal substances/preparations from non-European traditions. The main reasons herbal substances/preparations from non-European traditions were not accepted for inclusion in the Community herbal Monographs have been identified as due to unfulfilled requirements of Directive 2004/24/EC. The most common reasons were the lack of evidence to demonstrate a 15-year minimum medicinal use period in the EU and evidence of absence of health risk as required by Article 16a (1) (d), and Article 16a (1) (e). Conclusions Under the current EU legislation, the requirement to demonstrate 15-year minimum medicinal use in the EU is a major obstacle to the registration of non-European traditional herbal medicinal products. Access to scientific data to support the product safety profile may be a possible solution to overcome the hurdle presented by the 15-year minimum medicinal use period. Furthermore, the Community herbal Monographs play an important role in the registration process. Therefore, making full use of existing Community herbal Monographs, and promoting scientific research and subsequent development of additional Monographs for herbal substances and preparations, and combinations thereof from non-European traditions would be of benefit to herbal medicinal product registration from non-European traditions.

Stephen Prowse - One of the best experts on this subject based on the ideXlab platform.

  • from traditional inter library loan to a new interlending model the role of the curl Monograph interlending pilot
    Interlending & Document Supply, 2002
    Co-Authors: Stephen Prowse, Dennis Massie
    Abstract:

    The traditional inter‐library loan of Monographs is often seen as the future niche of interlending activity, with journal article supply being catered for by other means, such as full text access through e‐journals. Examines how a Monograph interlending pilot project, undertaken by CURL institutions, is part of a move towards a more distributed interlending model for the UK. Describes the project, presents statistical figures, and outlines results from feedback questionnaires. Shows the relationship to SHARES, RLG’s interlending program, and how the pilot has affected international interlending. Calls for other models to support the new interlending paradigm.

  • from traditional inter library loan to a new interlending model the role of the curl Monograph interlending pilot
    Interlending & Document Supply, 2002
    Co-Authors: Stephen Prowse, Dennis Massie
    Abstract:

    The traditional inter‐library loan of Monographs is often seen as the future niche of interlending activity, with journal article supply being catered for by other means, such as full text access through e‐journals. Examines how a Monograph interlending pilot project, undertaken by CURL institutions, is part of a move towards a more distributed interlending model for the UK. Describes the project, presents statistical figures, and outlines results from feedback questionnaires. Shows the relationship to SHARES, RLG’s interlending program, and how the pilot has affected international interlending. Calls for other models to support the new interlending paradigm.

Eve, Martin Paul - One of the best experts on this subject based on the ideXlab platform.

  • A new funding model for open-access Monographs
    2020
    Co-Authors: Eve, Martin Paul
    Abstract:

    We outline the work of a university press, with assistance from the COPIM Project (Community-led Open Publication Infrastructures for Monographs), in building an innovative revenue model to fund open access Monographs at a traditional publisher. Building on library journal subscription models (eg: OLH) and on Knowledge Unlatched's approach to Monograph funding, we present a sustainable OA publishing model that gives members exclusive access to a backlist, with the revenue then used to make the frontlist openly accessible. The model can be emulated by other scholarly presses who wish to take advantage of the opportunities that open access publishing affords

  • COPIM – Revenue Models for Open Access Monographs 2020
    2020
    Co-Authors: Penier Izabella, Eve, Martin Paul, Grady Tom
    Abstract:

    A report by the Community-led Open Publication Infrastructures for Monographs project (COPIM) analysing the open access economic models in use today in scholarly publishing. The report examines academic Monograph publishing in the context of today’s challenging Monograph publishing environment: from Covid-19 and budget cuts, to print sales, funder mandates, and research evaluation. Launched in 2019, and funded by Arcadia and Research England, the COPIM project is an international partnership of researchers, universities, librarians, open access (OA) book publishers and infrastructure providers. It is fostering community-owned, open systems and infrastructures to enable OA book publishing to flourish. This project report builds on a decade of studies written by OA advocates and consultants around the world, and updates their research to describe the environment and economics of OA publishing in 2020. The report will eventually become one component of a practical ‘toolkit’ that COPIM will produce on how presses might transition to sustainably publishing OA Monographs