CFDA be­comes a mem­ber of ICH

With a grow­ing num­ber of mem­bers and ob­servers, the changes in­clude caps on the size of Ex­pert Working Groups to en­sure they re­main a man­age­able size and re­vi­sions to the cri­te­ria for an in­ter­na­tional or­gan­i­sa­tion to be­come an Ob­server

BioSpectrum (Asia) - - Bio Special -

The In­ter­na­tional Coun­cil for Har­mon­i­sa­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), unique in bring­ing to­gether the reg­u­la­tory au­thor­i­ties and phar­ma­ceu­ti­cal in­dus­try to dis­cuss sci­en­tific and tech­ni­cal as­pects of drug regis­tra­tion met in Mon­treal, Canada on 27 May to 1 June 2017. Among other de­ci­sions, the ICH Assem­bly ap­proved the China Food and Drug Ad­min­is­tra­tion (CFDA) as a new Reg­u­la­tory Mem­ber, and Phar­ma­ceu­ti­cal In­spec­tion Co-op­er­a­tion Scheme (PIC/S) as a new Ob­server. With these new par­ties, there are now 14 mem­bers and 23 ob­servers.

The ICH Assem­bly agreed to be­gin work on two new top­ics. The first is for a new in­ter­na­tional har­monised guide­line on ex­trap­o­la­tion for pae­di­atric medicines. The new Working Group will fur­ther ad­vance the use of pae­di­atric ex­trap­o­la­tion, which is the fo­cus of the new ICH E11 (R1) guide­line cur­rently un­der devel­op­ment. The aim is to pro­vide guid­ance on in­cor­po­rat­ing ex­trap­o­la­tion meth­ods in an over­all ap­proach to pae­di­atric medic­i­nal prod­uct devel­op­ment. A har­monised ap­proach to the ap­pro­pri­ate use of ex­trap­o­la­tion from adult data will im­prove the speed of ac­cess to new drugs for chil­dren.

The sec­ond new topic is the re­vi­sion of the 1997 ICH E8 guide­line on gen­eral con­sid­er­a­tions for clin­i­cal tri­als. This is part of the strate­gic ‘GCP ren­o­va­tion’

an­nounced at the Novem­ber 2016 Osaka meet­ing. The re­vi­sion will look at study de­sign, plan­ning and con­duct, with a fo­cus on iden­ti­fy­ing and sup­port­ing a ba­sic set of critical-to-qual­ity fac­tors. Im­proved clin­i­cal tri­als con­trib­ute to pub­lic health by gen­er­at­ing bet­ter ev­i­dence to in­form reg­u­la­tory de­ci­sion-mak­ing, by avoid­ing the need for re­peat tri­als and un­nec­es­sary ex­po­sure for trial par­tic­i­pants, and help­ing to avoid dis­con­tin­u­a­tion of promis­ing devel­op­ment pro­grams.

The fi­nal M7(R1) ad­den­dum to the guide­line on Assess­ment and Con­trol of DNA Re­ac­tive (Mu­ta­genic) Im­pu­ri­ties in Phar­ma­ceu­ti­cals to Limit Po­ten­tial Car­cino­genic Risk was adopted by the ICH Assem­bly at Step 4 of the ICH process. The ad­den­dum pro­vides a list of com­pounds for which mu­ta­genic po­ten­tial and the thresh­old of tox­i­co­log­i­cal con­cern have been es­tab­lished.

The ICH Assem­bly adopted at Step 4 the up­date of the Ques­tions and An­swers on the im­ple­men­ta­tion guide pack­age of the guide­line E2B(R3): Elec­tronic Trans­mis­sion of In­di­vid­ual Case Safety Re­ports.

With a view to stream­lin­ing the op­er­a­tion of ICH, the Assem­bly made some re­vi­sions to the Ar­ti­cles of As­so­ci­a­tion and rules of pro­ce­dure. With a grow­ing num­ber of mem­bers and ob­servers, the changes in­clude caps on the size of Ex­pert Working Groups to en­sure they re­main a man­age­able size and re­vi­sions to the cri­te­ria for an in­ter­na­tional or­gan­i­sa­tion to be­come an Ob­server. ICH aims to at­tract and en­gage with all or­gan­i­sa­tions that are im­pacted by ICH har­mon­i­sa­tion and that can bring value to its work; the re­vised cri­te­ria try to make sure that ICH is en­gag­ing with rel­e­vant global um­brella or­gan­i­sa­tions at the high­est level of rep­re­sen­ta­tion.

In Mon­treal, the Assem­bly also wel­comed Stand­ing Ob­server In­ter­na­tional Fed­er­a­tion of Phar­ma­ceu­ti­cal Man­u­fac­tur­ers & As­so­ci­a­tions (IFPMA)’s plan to ini­tially use its seat on ICH Working Groups to fa­cil­i­tate the par­tic­i­pa­tion of IFPMA Na­tional As­so­ci­a­tion ex­perts in Working Groups. The next ICH meet­ing will take place on 11 – 16 Novem­ber 2017 in Geneva, Switzer­land.

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