23authorities (e.g., from Australia, Brazil, China, India, Russia, and Singapore). The
purpose of the RF is to provide a platform for the sharing of regulatory and scien-
tifi c expertise among regulatory authorities in order to enhance the availability of
safe and effective products in the global market. In March 2011, members of the
RF founded RF Cell Therapy Group (RFCTG) with the objective of mapping out
potential areas for convergence in the regulation of cellular therapy products,
informed by the view that an understanding of similarities and differences in
global regulations and policies relating to cellular therapy products is critically
important in identifying common ground for future regulatory convergence activi-
ties. The FDA proposed at the RF held in November 2010 in association with the
ICH that the RF consider undertaking a preliminary assessment of potential topics
of regulatory importance for cellular therapy products (Arcidiacono et al. 2012 ).
The RF Gene Therapy Group (RFGTG) constitutes a forum for discussing novel
technologies.
1.5.6 International Medical Device Regulators
Forum ( IMDRF )
Cognizance should also be taken of the role of the International Medical Device
Regulators Forum (IMDRF), a voluntary group of medical device regulators from
across the world, which replaced the Global Harmonization Task Force in 2011. Its
aim is to accelerate international harmonization with regard to the regulation of
medical devices (IMDRF 2015 ).
1.5.7 Asia-Pacifi c Economic Cooperation/Life Sciences
Innovation Forum ( APEC/LSIF )
APEC, established in 1989 to promote and facilitate trade among the Asian Pacifi c
countries, founded the Life Sciences Innovation Forum (LSIF 2002 ) in 2002. The
purpose of LSIF, a tripartite forum of the government, industry, and academia, is to
create a policy environment for life sciences innovation (LSIF 2002 ). At the 2011
workshop on stem cell product quality assurance and control, APEC/LSIF initiated
a process of identifying technical requirements for stem cell products for clinical
use. One of the primary objectives of the APEC/LSIF Regulatory Harmonization
Steering Committee is to identify international standards and guidelines to propose
to APEC members. In 2012, this committee identifi ed the promotion of regulatory
convergence for the regulation of cell- and tissue-based therapies as a priority work
area, starting with a harmonized understanding of cell- and tissue-based therapies
via training programs.
1 Stem Cell Therapy: Accepted Therapies, Managing the Hope of Society...