Health Canada-US FDA Consultation on ICH (Live & Webcast)

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Sir Frederick G. Banting Research Centre

251 Sir Frederick Banting Driveway

Ottawa, ON K1Y 0M1

Canada

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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 in November 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. 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 at http://www.ich.org/home.html.

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 US 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

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Draft Agenda

Health Canada - US FDA 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 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

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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

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

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)

Date and Time

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Sir Frederick G. Banting Research Centre

251 Sir Frederick Banting Driveway

Ottawa, ON K1Y 0M1

Canada

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