Avalere Health
An Inovalon Company

Apr 17, 2015

Stakeholder Input in the Harmonization of U.S. and Canadian Drug Development Regulations

On April 13, the Federal Register announced a public meeting entitled “Preparations for International Conference on Harmonization Steering Committee and Expert Working Group Meetings in Fukuoka, Japan.”

The meeting will take place on May 15, from 1pm to 4pm at FDA’s White Oak Campus in Silver Spring, MD and is of specific interest to pharmaceutical and biotech manufacturers developing products for the Canadian and U.S. markets.

One aim of the Canada-United States Regulatory Cooperation Council (RCC) initiative is to seek input on areas of current regulatory disharmony and where harmonized ICH guidelines would be beneficial.  During the last few years of the RCC, an increased alignment has been showcased through numerous results produced via the Regulatory Cooperation Council, including the creation of a Common Electronic Submission Gateway. It allows submission of electronic applications to both Health Canada and the U.S. Food and Drug Administration for pharmaceutical and biological products.

This public meeting will provide insight on key topics that may reach the forefront in efforts of harmonization among regulatory bodies in the United States, Canada, Europe, and Japan. Topics discussed at this preliminary meeting will mirror the topics presented during the face-to-face ICH Steering Committee Meeting in Fukuoka, Japan taking place one month later (June 2015). The May meeting will allow for public comment via oral presentations as well as through submissions posted to the Federal Register docket.  Stakeholder input received through this initiative will be considered in current or future guideline development. Of particular interest to stakeholders is Health Canada’s claim to also “use these opportunities to better understand areas where Canadian requirements may differ from those in place in the U.S., with a means of minimizing these differences.”

Stakeholders are encouraged to submit comments to Health Canada at HPFB_ICH_DGPSA@hc-sc.gc.ca, or to FDA as described in the Federal Register notice. Interested persons may present data, information, or views orally or in writing on issues pending at the public meeting as per the Federal Notice. Documents that are under development or revision and are up for discussion during the meeting are the following:

  • M2 - Electronic Standards for the Transfer of Regulatory Information

  • M8 - Electronic Common Technical Document (eCTD)

  • 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 and 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

  • M7 - Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk - moving towards implementation

  • Q3D - Guideline for Elemental Impurities - moving towards implementation

  • Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients: development of Q&As

  • 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

  • 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

  • E14 - Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

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