The regulation of natural products is a global challenge, given the multitude of regulatory pathways and different approaches globally. Therefore, GA, the Society for Medicinal Plants and Natural Product research, steps in a series of lectures on Regulatory Affairs for (traditional) herbal medicinal products, herbal food supplements (so called botanicals), and substance-based medical devices, with leading experts from industry, authorities and academia worldwide as lecturers. The aim is to help in differentiating the different market niches for herbal products in the countries of this world and to reveal pros and cons of the categories. Part A of the eSeminar, started in autumn 2021, gave an overview of the regulation of mainly supply and quality of the products from different regulatory pathways.
Part B of the eSeminar series in spring 2022, with four issues, gave insights to the regulation of the different types of natural products in different regions worldwide, again presented by renowned experts in the field.
Now Part C is starting on 2nd December with a kick-off on Regulatory Concepts in the EU, Switzerland and an alternative pathway through substance-based medical devices.
Work Priorities of the HMPC in 2023
Dr. Emiel van Galen,
College ter Beoordeling van Geneesmiddelen (The Netherlands)
Chairman Herbal Medicinal Products Committee (HMPC, EMA)
Phytotherapeutic Products in Switzerland
Dr. Martin Ziak, Swissmedic, Bern (Switzerland)
Medical Device Regulation (2017/745/EC) – current status of implementation
Dr. Heike Wollersen, Bundesverband der Arzneimittelhersteller, Bonn (Germany)