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

The Canada-United States (U.S.) Regulatory Cooperation Council (RCC) was created in February 2011 to better align the two countries' regulatory approaches, where possible.

Under the RCC initiative, Health Canada and the United States (U.S.) Food and Drug Administration (FDA) are holding joint public consultation meetings on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines currently under development. The aim of this initiative is to hold public consultation meetings prior to each bi-annual ICH face-to-face meeting, in order to seek input on areas of current regulatory disharmony and where harmonised ICH guidelines would be beneficial. Stakeholder input received through this initiative will be considered in current or future guideline development. Health Canada also intends to use these opportunities to better understand areas in drug product regulation where Canadian requirements may differ from those in place in the U.S., with a view to minimizing these differences.

How to Get Involved

The next ICH face-to-face meeting will take place from May 27-June 1, 2017 in Montreal, Canada. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on April 24, 2017, 11am-2pm, at the White Oak Campus of the U.S. FDA in Silver Spring, Maryland. Stakeholders will also be able to participate by webcast . Registration is to be completed online. Future meetings will continue to alternate between Canada and the U.S., with the next meeting (which is planned to be hosted by Health Canada) to occur in the fall of 2017 prior to the fall scheduled ICH meeting (which will be held in Geneva, Switzerland).

A draft agenda and list of guidelines currently under development or undergoing revision follow below. For additional information including Concept Papers and any available draft guidelines for comment please visit the ICH website.

In advance of the public meeting in October, Health Canada is also offering the opportunity for stakeholders to submit comments in writing for consideration by Health Canada and/or the U.S. FDA. Comments will be accepted from the date of this Notice until April 20, 2017 .

Please submit comments to the following email address: HPFB_ICH_DGPSA@hc-sc.gc.ca

Draft Agenda

Health Canada - U.S. FDA - ICH Consultation
April 24, 2017 11:00am-2:00 pm

1. Opening Remarks/Introductions
2. Overview of the ICH Process and ICH Reforms
3. Overview of MedDRA and MedDRA Points to Consider
4. Overview of Current Efficacy Topics
5. Overview of Current Safety Topics
6. Overview of Current Quality Topics
7. Overview of Current Electronic Standards Topics
8. Closing Remarks

Guidelines Under Development or Revision

• M2 - Electronic Standards for the Transfer of Regulatory Information
• E2B(R3) - Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
• M1 - MedDRA Points to Consider
• S1 - Rodent Carcinogenicity Studies for Human Pharmaceuticals - prospective study
• S3A - Toxicokinetics: the Assessment of Systemic Exposure in Toxicity Studies: development of Questions & Answers (Q&As)
• S5 - Detection of Toxicity to Reproduction for Medical Products & Toxicity to Male Fertility - guideline revision
• S9 - Nonclinical Evaluation for Anticancer Pharmaceuticals: development of Q&As
• S11 - Nonclinical Safety Testing in Support of Development of Paediatric Medicines - New guideline
• Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management - New guideline
• Q11 - Selection and Justification of Starting Materials for the Manufacture of Drug Substances: development of Q&As
• Q3C(R6) - Impurities: Guideline for Residual Solvents - Maintenance
• E9(R1) - Addendum: Statistical Principles for Clinical Trials
• E17 - Multi-Regional Clinical Trials - New guideline
• E11(R1) - Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population
• E18 - Genomic Sampling Methodologies for Future Use - New guideline

Guidelines Pending Implementation

• E6(R2) - Addendum: Good Clinical Practice
• E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• Q3D - Guideline for Elemental Impurities - moving towards implementation
• M4Q - Common Technical Document - Quality;
• M4E - Common Technical Document - Efficacy: Revision on Enhancing the Format and Structure of Benefit-Risk Information
• M7 - Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - moving towards implementation
• M8 - Electronic Common Technical Document (eCTD)

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact HPFB_ICH_DGPSA@hc-sc.gc.ca.

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