Abstract
Background:
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 need to further explore how to best advance regulatory collaboration under varying circumstances

Objectives:
To briefly explain the regulatory situation in Europe and in the USA. To explain the first World Integrated Medicine Forum on the Regulation of Homeopathic Medicinal
Products in Delhi in February 2017. To announce and explain the second World Integrated Medicine Forum on advancing global regulatory collaboration, in February 2019.

Presentation content:
In the majority of European countries there is a wellestablished regulatory framework. There is a wellharmonized simplified registration for single medicines as guided by Article 14, and a poorly harmonized marketing authorization procedure for specific homeopathic medicinal products as guided by Article 16. Regulatory collaboration
between European countries is generally poor.
In the USA the regulatory situation is quite different from Europe. Under the Federal Food, Drug and Cosmetic act of 1938, recognizes homeopathic ‘drugs’ as those recognized by the official Homeopathic Pharmacopoeia of the United States (HPUS). The Food and Drug Administration (FDA) Compliance Policy Guide 7132.15 (effective 1990) established the HPUS as the official list of drugs and standards for homeopathic medicines, as well as guidelines for ‘Over-The-Counter’ (OTC) use, and for labeling and indications for use.
The Homeopathic Pharmacopoeia Convention of the United States (HPCUS), is a non-governmental body with a mandate from the FDA with the following primary functions:
A) Pharmacy practices and procedures;
B) Drug standards and quality controls;
C) Safe minimum potencies; and
D) Monograph approval.
The HPUS has developed procedures and guidelines to better distinguish allopathic from homeopathic pre-marketing approval needs. As part of this process a homeopathic pathogenetic trial (proving) guideline was published in 2013, and a Clinical Data Guideline will be published in 2018. Monograph approval procedures
have been established, that meet both modern quality standards, as well as specific homeopathic requirements.
The Mission of the World Integrated Medicine Forum (WIMForum) is to further develop evidence based Traditional and Integrated Systems of Medicine by promoting public-private collaboration. The WIMForum engages government, political, business and academic leaders to shape global and regional agendas concerning Integrated Medicine. It organizes high level ‘invitation only’ events where key stakeholders in the rapidly growing field of Traditional and Integrated Medicine can meet for high level
strategic discussions on the current status and future.
The first WIMForum focused on the regulation of homeopathic medicinal products globally. It took place in Delhi, India from 23-24 February 2017 and was attended by delegates from over 25 countries. The Forum illustrated the different regulatory perspectives from countries worldwide and also explored ways of enhancing synergies with the regulation of other traditional and complementary medicine medications.
It also fostered a close bi-national collaboration between the Homeopathic Pharmacopoeia of the United States and the Ministry of AYUSH (comprising the Homeopathic
Pharmacopoeia of India) in India.
A second World Integrated Medicine Forum will take place in Delhi in February 2019, and focus how to advance global regulatory collaboration. It will explore regulatory collaborations in different scenarios ranging from countries without a homeopathic tradition to countries with a long homeopathic tradition. Best practices for implementing collaboration in various scenarios will be identified. In addition, the Forum will explore further regulatory topics, such as possible convergence on minimum standards, quality aspects and regulatory paradigms.

Conclusions:
The regulation of homeopathic medicinal products is highly variable worldwide. There is great potential for further regulatory collaboration, for instance between countries in
the BRICS group (Brazil, Russia, India, China and South Africa). Despite challenges and barriers, the potential benefits of regulatory collaboration and harmonization for
patients and global markets are significant.

Резюме
Основные вехи:
Регулирование гомеопатических лекарственных препаратов сильно различается во всем мире, изменяясь на национальном уровне от высокоразвитого до «никакого». Потенциальные преимущества нормативного сотрудничества и гармонизации для пациентов и глобальных рынков являются значительными, но наднациональное сотрудничество продвигается очень медленно из-за значительного различия в национальных законодательствах. Необходимо дополнительно изучить, как лучше всего продвигать нормативное сотрудничество в таких различающихся обстоятельствах.
Цели:
Чтобы кратко обрисовать регуляторную ситуацию в Европе и в США. Чтобы осветить работу первого мирового форума интегрированной медицины по регулированию гомеопатических лекарственных средств в Дели в феврале 2017. Для того, чтобы объявить о втором Всемирном форуме интегрированной медицины по продвижению глобального регулирующего сотрудничества, в феврале 2019 года.