Pharmaregulatory affairs working party
Chairperson: Dr. Gesine Klein
Agenda:
This working party deals with any developments relating to the construction of a specific and harmonised regulatory environment for homeopathic and anthroposophic medicinal products. Developments in the field of regulatory issues such as guidelines, formats for application, pharmacopoeia monographs etc. are critically monitored concerning quality and safety issues of homeopathic and anthroposophic substances. The working party develops models and position papers and formulates comments on proposals published by Competent Authorities in consultation with its stakeholders. Active and pro-active contacts with Competent Authorities are very important for this working party in order to clarify ECHAMP’s points of view. Four Subject Groups currently work under the umbrella of the ECHAMP pharmaregulatory working party.
Five subject groups currently work under the umbrella of the ECHAMP Pharmaregulatory working party.
Regulatory affairs subject group
Chairperson: Dr. Gesine Klein
Safe concentration list subject group
Chairperson: Dr. Birgit Rüdinger
Pharmacopoeia subject group
Mutual recognition subject group
Chairperson: Dr. Astrid Sprenger
Contact: office(at)echamp.eu


