On further examination , GDF and The Global Fund define the term “ stringent ” as being a Member , Observer or Associate of the International Council for Harmonisation ( ICH ). The ICH , founded in 1990 , is an association “ bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration .
Current ICH Regulatory Members or Associates are Brazil , Canada , the EU , Japan , South Korea , Switzerland and the US . In regard to ICH Members having newly acceded to the EU such as Cyprus , Lithuania , Malta , Poland and Latvia , the GDF Quality Assurance Policy principles additionally provide that “ GDF will consult with relevant WHO experts on the progress in adjusting their pharmaceutical legislation to EU laws before recognizing the approval by the national health authorities ”.
From 2015 , a range of Regulatory Authorities joined the ICH as Observers , namely Australia , Chinese Taipei , Cuba , India , Kazakhstan , Mexico , Russia , Singapore and South Africa . Both GDF ’ s and The Global Fund ’ s Quality Assurance Policies , which antedate 2015 , limit recognition to “ an ICH Observer , being the European Free Trade Association ( EFTA ) as represented by Swiss Medic , Health Canada and World Health Organization ( WHO ) ( as may be updated from time to time )”. Despite the closing adjustment clause , given the significant development in ICH
Observers and the generally restrictive nature of both organizations ’ policies , including the specific formulation of this provision , referring mainly to associations and only to one individual authority , moreover now an ICH “ Standing Regulatory Member ”, it must be understood that the nine new ICH Observers are currently not recognized as representing stringent regulatory environments . The conclusion must also be drawn in the absence of media releases to the contrary or other forms of clarification by the two organisations since 2015 on these significant developments at ICH , as well as lack of sourcing from those countries on the basis of ICH Observer status .
As a further qualifying option , according to the GDF Policy it will be sufficient that products are “ approved or subject to a positive opinion under the Canada S . C . 2004 , c . 23 ( Bill C-9 ) procedure , or Art . 58 of European Union Regulation ( EC9 No . 726 / 2004 ) or United States FDA tentative approval ”, i . e . interim approvals have been given by this set of countries / intergovernmental organisation . A next to identical regulation is found in The Global Fund ’ s Quality Assurance Policy .
In the event that none of the above requirements are met , GDF ’ s Quality Assurance policy then allows that “ Products shall be found acceptable to the GDF through a quality risk / benefit assessment process involving an Expert Review Panel ( ERP )”. While this specific , exceptional process was managed by the GDF itself until 2009 / 2010 , the ERP assessment was forthwith handled by The Global Fund , in cooperation with GDF . The Global Fund respectively refers to this process on its website and linked material . Under this backup process , for which approvals are limited to a 12-month period , product submissions must be pending with either the WHO Prequalification Programme or a stringent NRA . Also , the product must have been produced at a manufacturing site that was inspected and found acceptable by either the WHO Prequalification Programme , a stringent NRA or a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme ( PIC / S ).
PIC / S was established in 1995 as an extension to the Pharmaceutical Inspection Convention ( PIC ) of 1970 . There are currently 49 participating authorities ( Members ) in PIC / S , including beyond the 10 founding members from EFTA the following new entrants from 2000 : Argentina ( 2008 ), Chinese Taipei ( 2013 ), Hong Kong ( 2016 ), Indonesia ( 2012 ), Israel ( 2009 ), Korea ( Rep . of ) ( 2014 ), Malaysia ( 2002 ), New Zealand ( 2013 ), Singapore ( 2000 ), South Africa ( 2007 ), Thailand ( 2016 ) and Ukraine ( 2011 ) .
In regard to accepting PIC / S , the GDF Quality Assurance Policy nevertheless contains a similar caveat as for the ICH , stating that “ For any new PIC / s Member GDF will consult with relevant WHO experts on the level of equivalence of the GMP inspection level to those of old members PICs countries .”
2 . STRICT NRA STANDARD
The above definitions , despite developments in recent years in expanding membership and observers of ICH and PIC / S , remain in stark contrast to a meanwhile long-standing
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