Herbal medicinal product regulation – how to find ways to better harmonization

The World Health Organization estimated that 80% of people worldwide rely on herbal medicines for some part of their primary health care. The ways herbal medicines are regulated are nonetheless still quite different. The different medical systems, cultures and traditions have imprinted their mark on the legislations of phytomedicines in the different regions.

In Europe, the different national systems around traditional herbal medicines and remedies have been harmonized by Directive 2004/24/EC which created an EU-wide definition of 'traditional herbal medicines', defined a simplified authorisation system and set-up a full-fledged committee at the EMA level which issues monographs and gives opinions. Although the increasing number of decentralised and mutual recognition procedures in the EU may also be a sign of this growing harmonization, differences subsist. Regulatory systems in some non-European countries like Canada and Australia to some extent follow similar approaches. In the US, herbal medicines are rare and dominated by food supplements containing botanicals, while East Asian countries rely on their own traditions like TCM and Kampo.

This situation complicates bringing products onto the market for companies and meeting rising patients' needs and customers' demand for high-quality herbal products with accepted safety and efficacy.

The talk will attempt to provide a tour d'horizon of the main regulatory systems related to herbal medicines around the globe, particularly reflecting on the situation in Europe, and will raise a number of questions. Is it feasible to further harmonization e.g. through regulatory bilateral or multilateral discussions, cooperation, training, etc.? Does the lack of harmonization bear an impact on innovation? Could there be downsides to harmonization?