The International Harmonization Council (ICH) met in Singapore from 16 to 20 November 2019, bringing together over 450 participants from the sixteen ICH members and thirty-two observers.

At the meeting, the Assembly reviewed the status of the activities of all ICH working groups, including updates on several important recent activities regarding implementation and communication.

Several elections were also held in Singapore, with the following nominations:

• Lenita Lindström-Gommers (EC, Europe) and Dr. Celia Lourenco (Health Canada, Canada) were re-elected by the Assembly as President and Vice President respectively for a two-year term;

• Dr. Theresa Mullin (FDA, United States) and Dr. Nobumasa Nakashima (MHLW / PMDA, Japan) were re-elected by the ICH Management Committee as chair and vice-chair, respectively, to serve a one-year term; and

• Representatives of ANVISA, Brazil, were elected by the Assembly to the ICH Management Committee.

Among the key milestones achieved by the various ICH working groups, one particularly noteworthy was the adoption of the new ICH Q12 Guideline (Step 4 of the ICH process) on Technical and Regulatory Considerations for Pharmaceuticals – Product Lifecycle Management. This guideline complements the Quality guidelines (Q8 to Q11) and aims to promote innovation and improvement in the pharmaceutical industry, as well as strengthen product assurance and reliable supply, including proactive planning of global supply chain adjustments. The assembly also received the finalization of the work of two Working Groups, they are E9 (R1) – Step 4 of the ICH process, which deals with the Addendum to the Definition of Appropriate Estimate for a Clinical Trial / Sensitivity Analysis and the new ICH M9- Guideline that addresses systems-based Biowaivers  Biopharmaceutical Classification.

Both represent important areas of work, the Addendum E9 (R1) aimed at improving the design, design, analysis, and interpretation of clinical trials by providing greater structure and harmonized standards in the choice of estimates, while M9 provides recommendations to support classification biopharmaceuticals and waiver of bioequivalence studies.

Other groups advanced in Singapore with the finalization of conceptual documents and business plans, among them:

• E6 (R3): Good Clinical Practice;

• E2D (R1): Post-approval safety data management;

• E20: Adaptive Clinical Trials;

• Q5A (R2): Viral safety assessment of biotechnology products derived from human or animal cell lines;

• S12: Non-clinical biodistribution studies for gene therapy products;

• M12: Drug interaction studies.

Agreement on new ICH harmonization activities

The Assembly approved the Draft Concept Papers for bioequivalence topics for immediate release solids for oral dosage forms (M13) and a proposal for the revision of the ICH Q9 Guideline on Quality Risk Management.

In addition, the Assembly was briefed on the new Working Group that would be set up to start the discussion on the new guideline ICH Q3E- Evaluation and Control of Extractables and Leachables guideline topics, which was adopted in June of 2019.

Support for MedDRA’s continued global acceptance

The Assembly was briefed on the expanded number of MedDRA Training Offerings available to MedDRA users and the Management Committee, including efforts to enable terminological interoperability. Importantly, the progress of mapping developed with MedDRA adverse event terminology was also reported.

For those unfamiliar with the term MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international dictionary of the terminology used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities and also for entry, retrieval, evaluation and presentation of safety information data.

ICH Guidelines Implementation Monitoring

On the monitoring and progress of international harmonization, the focus was given to the November 2019 publication on the ICH website, which looks at the results of recent research conducted to understand the state of implementation of the ICH Guidelines by Members and Observers.

Training

The assembly was also updated on ICH training-related activities, especially with regard to Training Programs and efforts to engage non-profit training organizations, assisting the Council in its efforts to meet the training needs of its Regulatory Members. and Observers and also from Industry in a strategic way.

ICH Official web site: https://www.ich.org