Regulatory Affairs Workshop Program

Date: August 26th, 2018

Time: 13.30 – 17.00

Theme: Globalization of Herbal and Traditional Medicines  

Chair: Werner Knöss   


                                                                                                                                                   Updated on August 14




Welcome and introduction

Examples of multi-national harmonization of regulatory frameworks

Werner Knöss (BfArM, Germany)

13.45 – 14.20

25 minutes plus discussion

Botanical Drugs in the USA

Charles Wu (FDA, USA)

14.20 – 14.55

25 minutes plus discussion

Regulatory Framework for TCM in China

De-an Guo (SIMM, China)

14.55 – 15.25


15.25 – 16.00

25 minutes plus discussion

Herbal Drugs in the European Pharmacopeia

Rudolf Bauer (Chairperson TCM-expert group, EDQM, University of Graz, Austria)

16.00 – 17.00

Discussion with speakers and participants

a) What is the impact of globalization of traditional medicines on regulation and vice versa?

b) Is there a chance and is there a reasonable way forward towards a partial convergence of regulatory frameworks for herbal and traditional medicines?

c) Which contributions can be given by the scientific community?