ICH Updates on Guidelines, Future Topics

Regulatory NewsRegulatory News | 26 November 2018 |  By 

The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier this month.
ICH also said it has finished implementing the reforms set out in 2015 to make the organization more global.
“Three years on from the reform of ICH, all organizational changes have been implemented,” ICH writes, noting that its membership has grown to include 16 members and 28 observers, with Iran’s regulatory agency joining as an observer during the Charlotte meeting.
At the meeting ICH also elected Petra Doerr of Swissmedic as ICH Assembly vice-chair and elected Nobumasa Nakashima from Japan’s Ministry of Health, Labour and Welfare as vice-chair of the ICH Management Committee and re-elected Theresa Mullin of the US Food and Drug Administration as chair of the ICH Management Committee.
According to ICH, 13 of its 25 working groups met during the Charlotte meeting. The ICH Management Committee also endorsed the concept papers and business plans for three recently established working groups, Analytical Procedure Development and Revision of Q2(R1) Analytical Validation (Q2(R2)/Q14), Continuous manufacturing (Q13) and Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation (E14/S7B).
ICH said that timelines have also been established for two recently adopted topics, adaptive clinical trials (E20) and drug interaction studies (M12). Work on the two guidelines is expected to begin in mid-2019.
Additionally, ICH said that a new reflection paper on opportunities for harmonizing standards for generic drug was also adopted at the meeting and discussions were held on a potential new topic aimed at harmonizing requirements for pharmacoepidemiological studies.
ICH said that progress has been made on a survey intended to map the implementation of ICH guidelines by its members and observers. The survey is expected to be completed by mid-2019, with results published in the second half of the year.
In a separate press release, the MedDRA (Medical Dictionary for Regulatory Activities) Management Committee announced that it will discount MedDRA subscription fees by 5% at all levels to further expand its user base globally beginning in 2019.
“With an expanding user base, the costs of maintaining and developing the terminology can be distributed more widely, whilst still providing the same high standard of tools and services to MedDRA users,” ICH writes.
The MedDRA Management Committee also said that a Russian translation of MedDRA “is well underway,” though it did not provide an estimate for when it would be completed.


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