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FDA and Health Canada to Jointly Discuss ICH Topics

Posted 22 February 2018 | By Zachary Brennan 

FDA and Health Canada to Jointly Discuss ICH Topics

Ahead of the International Council of Harmonisation’s (ICH) June meeting in Kobe, Japan, the Canada-US Regulatory Cooperation Council (RCC) will meet to discuss areas where harmonized ICH guidelines could be beneficial.

The US Food and Drug Administration (FDA) and Health Canada, under an agreement crafted in February 2011 to better align the two countries’ regulatory approaches, are seeking comment on current or future guideline development ahead of a meeting on 6 April in Silver Spring, MD.

And Health Canada said it also intends to use these opportunities to better understand areas in drug product regulation where Canadian requirements may differ from those in US, “with a view to minimizing these differences.”

Topics currently under regional public consultation (Step 3 of ICH Process) include:
  • S11 Nonclinical Safety Testing in Support of Development of Pediatric Medicines
  • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • E9 (R1) Addendum: Statistical Principles for Clinical Trials
  • Selected Topics Recently Finalized (Step 4 of ICH Process):
  • E17 General Principles on planning/designing Multi-Regional Clinical Trials
  • Electronic Standards and MedDRA:
  • M2 Electronic Standards for the Transfer of Regulatory Information
  • M8 Electronic Common Technical Document (eCTD)
  • E2B Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
  • M1 MedDRA Terminology
Additional ongoing topics include:
  • E19 Optimization of Safety Data Collection
  • E8(R1) Revision on General Considerations for Clinical Trials
  • E11A Pediatric Extrapolation
  • E14/S7B Discussion Group on Clinical and non-Clinical Evaluation of QT/QTc Interval Prolongation
  • M9 Biopharmaceutics Classification System-based Biowaivers
  • M10 Bioanalytical Method Validation
  • S1(R1) Revision on Rodent Carcinogenicity Studies for Human Pharmaceuticals
  • S5(R3) Revision on Detection of Toxicity to Reproduction for Human Pharmaceuticals
  • Q3C(R7) Impurities: Guideline for Residual Solvents
  • Q3D(R1) Guideline on Elemental Impurities
Future consultations will continue to alternate between Canada and the US, with the next meeting to be hosted by Health Canada in the fall of 2018.

In advance of the public meeting on 6 April 2018, Health Canada and FDA are offering the opportunity for stakeholders to submit comments in writing until 4 April 2018 to the following email address: HPFB_ICH_DGPSA@hc-sc.gc.ca.
 
Registration 

Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Council on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use
 

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