BioSpectrum (Asia) - - Bio Special -

The Med­i­cal Dic­tio­nary for Reg­u­la­tory Ac­tiv­i­ties (MedDRA) Main­te­nance and Sup­port Ser­vices Or­ga­ni­za­tion (MSSO) and the Ja­panese Main­te­nance Or­ga­ni­za­tion (JMO) re­ported on the growth of their sub­scriber bases. The num­ber of sub­scrib­ing or­ga­ni­za­tions to MedDRA is now over 5,000 in 103 coun­tries. This re­flects the suc­cess­ful adop­tion of MedDRA as a world­wide stan­dard in the pro­tec­tion of pub­lic health. Fu­ture ar­eas of fo­cus for the MSSO in­clude con­tin­u­ing to sup­port the global use of MedDRA and ex­plor­ing in­ter­op­er­abil­ity be­tween MedDRA and other med­i­cal ter­mi­nolo­gies.

The Board of MedDRA-an ICH stan­dard­ised dic­tio­nary of med­i­cal terminology, noted that the MSSO and the World Health Or­gan­i­sa­tion (WHO) Col­lab­o­rat­ing Cen­tre for In­ter­na­tional Drug Mon­i­tor­ing (Upp­sala Mon­i­tor­ing Cen­tre) held their first joint MedDRA and WHO Drug User Group meet­ings in Ban­ga­lore and Mumbai, In­dia in Fe­bru­ary 2017. Fol­low­ing this suc­cess­ful col­lab­o­ra­tion, an­other joint MedDRA/WHO Drug meet­ing is planned for Beijing, China in Septem­ber 2017.

The Board noted the ef­forts of the ICH M1 Points to Con­sider (PtC) Working Group in sup­port­ing MedDRA’s global up­take. The Working Group has de­vel­oped con­densed ver­sions of the PtC doc­u­ments for trans­la­tion into all MedDRA lan­guages (English and Ja­panese ver­sions will re­main in full) to sup­port the im­ple­men­ta­tion and use of MedDRA world­wide. These con­densed doc­u­ments will be made avail­able to MedDRA users in 2017.

The Board also noted that the Working Group has be­gun devel­op­ment of a com­pan­ion doc­u­ment to the PtC doc­u­ments, avail­able in English and Ja­panese. This doc­u­ment will pro­vide more de­tailed guid­ance, ex­am­ples, and “Ques­tions and An­swers” on top­ics of reg­u­la­tory im­por­tance such as data qual­ity and med­i­ca­tion er­rors. The first edi­tion of the com­pan­ion doc­u­ment is ex­pected to be avail­able in 2018.

The MSSO re­ported that the MedDRA Self-Ser­vice Ap­pli­ca­tion was launched in April 2017. This web-based tool al­lows MedDRA users to re­trieve sub­scrip­tion in­for­ma­tion and pass­words, con­firm the sub­scrip­tion sta­tus of busi­ness part­ners, and ob­tain cer­tifi­cates for at­tend­ing face-to-face train­ing classes.

The Board ac­knowl­edged the sig­nif­i­cant work of the CIOMS SMQ Im­ple­men­ta­tion Working Group (IWG) and noted that one new SMQ In­fec­tive pneu­mo­nia will go into pro­duc­tion in Septem­ber 2017 for MedDRA Ver­sion 20.1.

The Board was also up­dated on other im­por­tant ini­tia­tives and de­vel­op­ments. The MSSO re­ported on its par­tic­i­pa­tion in the In­no­va­tive Medicines Ini­tia­tive’s WEB-RADR (Recog­nis­ing Ad­verse Drug Re­ac­tions) pro­ject and the devel­op­ment of a draft set of “pa­tient friendly terms” to sup­port di­rect pa­tient re­port­ing through mobile ap­pli­ca­tions and web por­tals.

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