New global drug regulators forum takes shape
This article was originally published in SRA
A new global drug regulators-only group that is aspiring to become a key player in promoting international regulatory collaboration in the pharmaceutical arena is pressing on with efforts to solidify its status.
The International Pharmaceutical Regulators Forum is loosely connected with – but not part of – the regulators-industry group on harmonizing global drug regulations, the International Conference on Harmonisation. The IPRF was established in June1 and expects to finalize its terms of reference in November, according to Lenita Lindström-Gommers, a senior policy officer at the European Commission and an ICH steering committee member.
The IPRF comprises representatives from 16 regulatory authorities. It will hold its meetings in conjunction with the bi-annual meetings of the ICH and will be able to discuss topics beyond those on the ICH agenda. Its meetings will allow the regulators to exchange views on various topics among themselves without industry being present. Ms Lindström-Gommers said the forum had plenty of ideas for topics for discussion.
The IPRF replaces the Regulators Forum, which was formed in 2008 and which had participation from both ICH regulators (from the US, Japan and the EU) and non-ICH regulatory members of the ICH Global Co-operation Group. The Regulators Forum had also met in conjunction with ICH meetings, but attendance was sporadic.
The IPRF has a more formal structure than its predecessor in that it has a chair (Switzerland), a co-chair (Japan) and a secretariat; Switzerland will provide the secretariat for at least a year. This more formal structure, Ms Lindström-Gommers believes, will encourage more authorities to participate at the IPRF. Part of the reason as to why the ICH has been a success (the ICH has been running for over 20 years and has produced over 50 guidelines on harmonizing requirements for the authorization of medicinal products) is because it has permanent secretariat, she added. A permanent secretariat ensures the continuity of the work between the biannual meetings.
IPRF meetings will be held in conjunction with the next ICH steering committee meeting – in Osaka, Japan, on 9-14 November.
Ms Lindström-Gommers is a senior policy officer at the commission unit responsible for drug product authorizations and the European Medicines Agency (Unit D5/ Directorate General for Health and Consumers). She was speaking at the 10th TOPRA Annual Symposium in Lisbon on 17 October.
The GCG
The ICH GCG includes representatives from other regional harmonization initiatives – ie the Asia Pacific Economic Cooperation ( APEC), the Association of South East Asian Nations (ASEAN), the the East Africa Community (EAC), the Gulf Cooperation Council (GCC), the Pan-American Network for Drug Regulatory Harmonization (PANDRH) and the Southern African Development Community (SADC) – and also from Australia, Brazil, Canada, China, Chinese Taipei (Taiwan), India, South Korea, Russia and Singapore2.
References
- PMDA updates June 2013, www.pmda.go.jp/english/international/pdf/update/updates_201306_e.pdf
- ICH website, accessed 18 October 2013, www.ich.org/about/organisation-of-ich/coopgroup.html