The regulation of homeopathic medicinal products is highly variable worldwide, ranging at a national level from highly advanced to none whatsoever. The potential benefits of regulatory collaboration and harmonization for patients and global markets are significant, but supranational collaboration is advancing only slowly due to highly disparate national situations.
There is a tension between different regulatory needs: on the one hand there is a need for standardization, harmonization and reducing complexity; on the other hand there is need for a pluralistic regulatory system, which respects the specific characteristics of homeopathy as a holistic, patient-centred medical system.
This forum will explore and illustrate the potential benefits and pitfalls of bi-lateral/multilateral collaboration and advance global cooperation on a synergistic basis.
Vision of the Forum:
The increasing demand for homeopathic products by patients and health care providers worldwide needs to be underpinned by appropriate regulatory frameworks which respect the national context as well as benefit from experiences and collaboration at an international level.
Key stakeholders and opinion leaders who will be invited to attend:
- Regulators from all over the world
- Homeopathic pharmaceutical companies worldwide
- Pharmacopoeia Committee delegates from various countries
- Scientific experts with relevant expertise
- Presidents of major homeopathic doctor organizations
- Regulatory Collaboration
- Between countries with a 'mature' homeopathic tradition
- Between countries with an 'emerging' homeopathic tradition
- How to introduce homeopathic regulation in countries with little or no homeopathic tradition?
- Between groups of countries and/or bi-lateral; special themes*:
o Implementing collaboration: lessons learnt so far
- Between EurAsian Economic Union (EAEU) countries and India
- Between BRICS countries
* Parallel translation into Russian will be provided
- Converging on minimum standards:
- Minimum legal and regulatory standards
- Minimum quality standards
- Is a minimum consensus needed and possible?
- Advancing safety and quality standards:
- Collaborating on assay development: challenges and opportunities
- Regulatory trends
- Trend 1: Towards standardization and minimizing complexity;
- When is this appropriate and useful?
- When is this not appropriate and too reductionist?
- How can this be further facilitated when appropriate?
- Trend 2: Towards recognizing homeopathy as a distinct, holistic medical system.
- How can this be reflected in the regulatory framework?
- Is there a need to “think out of the current regulatory box”?
- It is possible to reflect scientific pluralism in the sphere of marketing authorizations?
- Are synergies possible with the regulation of other ‘whole person orientated’ medical systems, such as Ayurveda, TCM, etc.?
- Can both trends be united within a single regulatory framework?
The forum will consist of plenary lectures, parallel group sessions and plenary discussion forums.