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1.5.4 US Food and Drug Administration (FDA)
and the European Medicines Agency (EMA)
Increased collaboration between the EMA and the FDA has led to concerted efforts
to converge regulatory activities among international regulators in the fi eld of cell
therapy.
1.5.4.1 FDA-EMA-Health Canada ATMP Cluster
In 2008, the US FDA and EMA established the Advanced Therapy Medicinal
Products (ATMP) Cluster, with Health Canada joining in June 2012. Its aim is to
provide, among others, a platform for discussing different regulatory approaches
and for sharing information on draft documents.
1.5.5 International Conference on Harmonization
of Technical Requirements for Registration
of Pharmaceuticals for Human Use (ICH)
The International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH and the International Medical
Device Regulators Form (IMDRF), which replaced the Global Harmonization Task
Force (GHTF) , are two important international task forces formed specifi cally for
the purpose of promoting global harmonization. The ICH is comprised of industry
and regulatory agency representatives from the USA, Europe, and Japan (along with
several nonvoting observers, such as Canada and Australia). It has developed com-
mon guidelines on safety, effi cacy, quality, and multidisciplinary issues in the fi eld
of pharmaceutical regulation. The ICH has not formulated any guidelines specifi c to
stem cell-based products, but its guidelines on biotechnology products provide
some direction (e.g., Q5A (RI); Q5B; Q5D; Q6B; Q7, Q8, Q9 and Q11).
1.5.5.1 ICH (Regulators Forum Cell Therapy Group ( RFCTG )
and Regulators Forum Gene Therapy Group (RFGTG) )
The Regulators Forum (RF) consists of the ICH members (US FDA, EMA, and
Japan PMDA/MHLW), ICH observers (Canada, European Free Trade Association
(EFTA), WHO), regional harmonization initiatives (APEC, Association of the
Southeast Asian Nations (ASEAN), Southern African Development Community
(SADC), Gulf Cooperation Council (GCC), Pan-American Network for Drug
Regulatory Harmonization (PANDRH)), as well as individual drug regulatory
W.M. Botes et al.