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

August 29, 2016
Our Reference Number: 16-109635-274

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 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.

The next ICH face-to-face meeting will take place from November 5-10 2016 in Osaka, Japan. In preparation for this meeting, a public consultation for Canadian and U.S. stakeholders under the RCC initiative will take place on October 24, 2016, 1pm-3pm, at the Tunney’s Pasture campus of Health Canada in Ottawa, Ontario. Stakeholders will also be able to participate by webcast. If you wish to participate in this public consultation, advance registration is required. Future meetings will continue to alternate between Canada and the USA, with the next meeting (which is planned to be hosted by FDA) to occur in the Spring of 2017 prior to the next scheduled ICH meeting (which will be held in Montreal, Canada).

A draft agenda and list of guidelines currently under development or undergoing revision follows 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 October 20, 2016.

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

Draft Agenda
Health Canada - United States Food and Drug Administration (US FDA)
International Council for Harmonisation (ICH) Consultation
October 24, 2016 1:00-3:00 pm

1. Opening Remarks/Introductions
2. Overview of the ICH Process and ICH Reforms
3. Value of ICH to Industry
4. Overview of MedDRA (Medical Dictionary for Regulatory Activities) and MedDRA Points to Consider
5. Overview of Current Efficacy Topics
6. Overview of Current Safety Topics
7. Overview of Current Quality Topics
8. Overview of Current Electronic Standards Topics
9. 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 - Impurities: Guideline for Residual Solvents - Maintenance
• M4Q - Common Technical Document - Quality; and M4E - Common Technical Document - Efficacy: Revision on Enhancing the Format and Structure of Benefit-Risk Information
• E6(R2) - Addendum: Good Clinical Practice
• 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

• E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
• Q3D - Guideline for Elemental Impurities - moving towards implementation
• 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)