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

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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, 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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