International Council for Harmonisation (ICH)

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

The ICH Assembly adopted several guidelines for Step 4 of the ICH process, while several working groups advanced early stage efforts toward the development of new topics and upcoming revisions to existing guidelines.

The newly adopted guidelines include:

Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

E9(R1): Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses and

M9: Biopharmaceutics Classification System-Based Biowaivers.

ICH called the adoption of the Q12 guideline “particularly noteworthy,” and said that it “aims to promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments.”

In Singapore, ICH working groups finalized concept papers and business plans for six new topics:

E6(R3): Good Clinical Practice

E2D(R1) Post Approval Safety Data Management: Definition and Standards for Expedited Reporting

E20: Adaptive Clinical Trials

Q5A(R2): Viral Safety Evaluation of biotechnology Products Derived from Cell Lines of Human or Animal Origin

S12: Nonclinical Biodistribution Studies for Gene Therapy Products 

M12: Drug Interaction Studies.

The Assembly also approved concept paper outlines for two topics raised at its previous meeting in Amsterdam last June, M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms and a revision to Q9: Guideline on Quality Risk Management.

Additionally, ICH said that a working group will be established to start on a topic that was adopted in Amsterdam on the assessment and control of extractables and leachables for pharmaceuticals and biologics.

The Assembly voted to re-elect Lenita Lindström-Gommers from the European Commission and Celia Lourenco of Health Canada as the its chair and vice chair for new two-year terms. Theresa Mullin from the US Food and Drug Administration and Nobumasa Nakashima representing Japan’s Ministry of Health, Labour and Welfare were also re-elected to serve as the chair and vice chair of the ICH Management Committee. ICH also noted that representatives of Brazil’s ANVISA were elected to the ICH Management Committee.

ICH