Drug Development of Herbal Medicines: Regulatory Perspectives

  • 4,846

    Total Downloads

  • 23k

    Total Views and Downloads

Submit your idea

You will be redirected to our submission process.

Submit your manuscript summarySubmit your manuscript

About this Research Topic

Submission closed

Background

Traditional therapies based on plant medicines have been documented in great detail and are used globally. The development of novel medicines is embedded in different regulator systems. The variable status of ‘herbal medicines’ is equally complex as it is evident already from the complex terminology like listed as medicines (Australia), herbal medical products (European Union), botanicals (USA), or natural health products (Canada). These systems are either defined at a national level, like in India, China, and the USA, or they cover a region (group of countries), like the European Union or the Americas where people depend on medicinal plants but it is dispersed among different ethnic groups. Researchers are required to follow the regulatory requirements of the country/region where they wish to develop/use a product. However, for many of these systems, the regulatory framework is weak both in terms of their legal basis and enforcement.

This Research Topic focuses on the impact of these complex regulatory frameworks and their interpretations on the development of novel herbal medical products. Such developments may not focus on medicine (drug) development as such, but the aim may also be to market these products as cosmetics, supplements, or even foods. Simplified procedures are commonly used for herbal medicinal products considered to be safe. For example, in India, “phytopharmaceuticals” can be registered based on simplified clinical trials.

In this Research Topic, the focus is on regulatory science and on what is needed in terms of R&D in this context. We encourage primary reports and reviews on the context of regulation and herbal medicine development, including:
• Pre-clinical studies and clinical trials on the activity in the context of registering/licensing a medicine of plant origin.
• Safety is often a hallmark of these research and development strategies, and, therefore, analysis of the implementation of such safety assessments will be welcome.
• Regulatory requirements for drug development from plant origin especially in the context of changing national legislations and on a comparative basis between countries and regions.
• Assessments of the evidence base required for such regulated products.

Topic Editor Dr Chandrakant Katiyar is the CEO of Emami Ltd (India). All other Topic Editors declare no competing interests with regards to the Research Topic subject.

---

All the manuscripts submitted to the collection will need to fully comply with the Four Pillars of Best Practice in Ethnopharmacology (you can freely download the full version here).

---

Keywords: Plant medicines, Phytopharmaceuticals, Clinical trial, Regulatory requirements

Important note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

Topic editors

Frequently asked questions

  • Frontiers' Research Topics are collaborative hubs built around an emerging theme.Defined, managed, and led by renowned researchers, they bring communities together around a shared area of interest to stimulate collaboration and innovation.

    Unlike section journals, which serve established specialty communities, Research Topics are pioneer hubs, responding to the evolving scientific landscape and catering to new communities.

  • The goal of Frontiers' publishing program is to empower research communities to actively steer the course of scientific publishing. Our program was implemented as a three-part unit with fixed field journals, flexible specialty sections, and dynamically emerging Research Topics, connecting communities of different sizes and maturity.

    Research Topics originate from the scientific community. Many of our Research Topics are suggested by existing editorial board members who have identified critical challenges or areas of interest in their field.

  • As an editor, Research Topics will help you build your journal, as well as your community, around emerging, cutting-edge research. As research trailblazers, Research Topics attract high-quality submissions from leading experts all over the world.

    A thriving Research Topic can potentially evolve into a new specialty section if there is sustained interest and a growing community around it.

  • Each Research Topic must be approved by the specialty chief editor, and they fall under the editorial oversight of our editorial boards, supported by our in-house research integrity team. The same standards and rigorous peer review processes apply to articles published as part of a Research Topic as for any other article we publish.

      In 2023, 80% of the Research Topics we published were edited or co-edited by our editorial board members, who are already familiar with their journal's scope, ethos, and publishing model. All other topics are guest edited by leaders in their field, each vetted and formally approved by the specialty chief editor.

  • Publishing your article within a Research Topic with other related articles increases its discoverability and visibility, which can lead to more views, downloads, and citations. Research Topics grow dynamically as more published articles are added, causing frequent revisiting, and further visibility.

    As Research Topics are multidisciplinary, they are cross-listed in several fields and section journals – increasing your reach even more and giving you the chance to expand your network and collaborate with researchers in different fields, all focusing on expanding knowledge around the same important topic.

    Our larger Research Topics are also converted into ebooks and receive social media promotion from our digital marketing team.

     

  • Frontiers offers multiple article types, but it will depend on the field and section journals in which the Research Topic will be featured. The available article types for a Research Topic will appear in the drop-down menu during the submission process.

    Check available article types here 

  • Yes, we would love to hear your ideas for a topic. Most of our Research Topics are community-led and suggested by researchers in the field. Our in-house editorial team will contact you to talk about your idea and whether you’d like to edit the topic. If you’re an early-stage researcher, we will offer you the opportunity to coordinate your topic, with the support of a senior researcher as the topic editor. 

    Suggest your topic here 

  • A team of guest editors (called topic editors) lead their Research Topic. This editorial team oversees the entire process, from the initial topic proposal to calls for participation, the peer review, and final publications.

    The team may also include topic coordinators, who help the topic editors send calls for participation, liaise with topic editors on abstracts, and support contributing authors. In some cases, they can also be assigned as reviewers.

  • As a topic editor (TE), you will take the lead on all editorial decisions for the Research Topic, starting with defining its scope. This allows you to curate research around a topic that interests you, bring together different perspectives from leading researchers across different fields and shape the future of your field. 

     

    You will choose your team of co-editors, curate a list of potential authors, send calls for participation and oversee the peer review process, accepting or recommending rejection for each manuscript submitted.

  • As a topic editor, you're supported at every stage by our in-house team. You will be assigned a single point of contact to help you on both editorial and technical matters. Your topic is managed through our user-friendly online platform, and the peer review process is supported by our industry-first AI review assistant (AIRA).

  • If you’re an early-stage researcher, we will offer you the opportunity to coordinate your topic, with the support of a senior researcher as the topic editor. This provides you with valuable editorial experience, improving your ability to critically evaluate research articles and enhancing your understanding of the quality standards and requirements for scientific publishing, as well as the opportunity to discover new research in your field, and expand your professional network.

  • Yes, certificates can be issued on request. We are happy to provide a certificate for your contribution to editing a successful Research Topic.

  • Research Topics thrive on collaboration and their multi-disciplinary approach around emerging, cutting-edge themes, attract leading researchers from all over the world.

  • As a topic editor, you can set the timeline for your Research Topic, and we will work with you at your pace. Typically, Research Topics are online and open for submissions within a few weeks and remain open for participation for 6 – 12 months. Individual articles within a Research Topic are published as soon as they are ready.

    Find out more about our Research Topics

  • Our fee support program ensures that all articles that pass peer review, including those published in Research Topics, can benefit from open access – regardless of the author's field or funding situation.

    Authors and institutions with insufficient funding can apply for a discount on their publishing fees. A fee support application form is available on our website.

  • In line with our mission to promote healthy lives on a healthy planet, we do not provide printed materials. All our articles and ebooks are available under a CC-BY license, so you can share and print copies.

     

Impact

  • 23kTopic views
  • 16kArticle views
  • 4,846Article downloads
View impact