Preprint / Version 1

Technology Readiness Level Roadmap for Developing Innovative Herbal Medicinal Products

Authors

  • Eduardo Pagani Medical Department, Azidus Brasil, Valinhos 13271-130, SP, Brazil
  • Cristina Ropke Centroflora Group, Innovation Department, Campinas 06460-040, SP, Brazil
  • Cristiane Soares Project Management Office, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil
  • Sandra Perez Project Management Office, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil
  • Paulo Benevides Business Office, Oswaldo Cruz Foundation, Campo Grande 79081-746, MS, Brazil
  • Barbara Barbosa Centroflora Group, Innovation Department, Campinas 06460-040, SP, Brazil
  • Ana Carvalho GMESP, Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), Brasília 71205-050, DF, Brazil
  • Maria Behrens Natural Products Department, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil

Keywords:

phytotherapy, technology readiness level, herbal substance, herbal preparation, herbal medicinal products, drug discovery, drug development

Abstract

Despite the vast global botanical diversity, the pharmaceutical development of herbal medicinal products (HMPs) remains underexploited. Of over 370,000 described plant species, only a few hundred are utilized in HMPs. Most of these have originated from traditional use, and only a minority come from megadiverse countries. Exploiting the pharmacological synergies of the hundreds of compounds found in poorly studied plant species may unlock new therapeutic possibilities, enhance megadiverse countries’ scientific and socio-economic development, and help conserve biodiversity. However, extensive constraints in the development process of HMPs pose significant barriers to transforming this unsatisfactory socio-economic landscape. This paper proposes a roadmap to overcome these challenges, based on the technology readiness levels (TRLs) introduced by NASA to assess the maturity of technologies. It aims to assist research entities, manufacturers, and funding agencies from megadiverse countries in the discovery, development, and global market authorization of innovative HMPs that comply with regulatory standards from ANVISA, EMA, and FDA, as well as WHO and ICH guidelines. Keywords: phytotherapy, technology readiness level, herbal substance, herbal preparation, herbal medicinal products, drug discovery, drug development

Author Biographies

Eduardo Pagani, Medical Department, Azidus Brasil, Valinhos 13271-130, SP, Brazil

Conceptualization, Methodology, Validation, Investigation, Writing – original draft, Writing – review & editing

Cristina Ropke, Centroflora Group, Innovation Department, Campinas 06460-040, SP, Brazil

Conceptualization, Methodology, Validation, Investigation, Writing – review & editing

Cristiane Soares, Project Management Office, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil

Conceptualization, Methodology, Validation, Investigation, Writing – review & editing

Sandra Perez, Project Management Office, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil

Conceptualization, Methodology, Validation, Investigation, Writing – review & editing

Paulo Benevides, Business Office, Oswaldo Cruz Foundation, Campo Grande 79081-746, MS, Brazil

Investigation, Writing – review & editing

Barbara Barbosa, Centroflora Group, Innovation Department, Campinas 06460-040, SP, Brazil

Conceptualization, Investigation, Writing – review & editing

Ana Carvalho, GMESP, Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária (ANVISA), Brasília 71205-050, DF, Brazil

Conceptualization, Validation, Writing – review & editing

Maria Behrens, Natural Products Department, Vice Direction of Education, Research and Innovation, Institute of Drug Technology Farmanguinhos, Oswaldo Cruz Foundation, Rio de Janeiro 21041-250, RJ, Brazil

Conceptualization, Methodology, Validation, Investigation, Writing – review & editing

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