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
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
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
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