Health Canada Module 1 Updates and Progess Towards ... - TOPRA
Health Canada Module 1 Updates and Progess Towards ... - TOPRA
Health Canada Module 1 Updates and Progess Towards ... - TOPRA
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10. Notice - Increased Scope of Submissions being accepted in Electronic Common Technical Document<br />
(eCTD) electronic-only filing format: 30-Sep-11: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applicdem<strong>and</strong>e/guide-ld/ctd/ectd/notice_scope_ectd_avis_augm-eng.php<br />
11. Boehringer Ingelheim, Glaxo-Smith Kline, Image Solutions Inc, Lundbeck, Inc, Merck, Pfizer, sanofiaventis,<br />
Takeda, <strong>and</strong> ePharmaCMC; March, 2010, Industry Book of Knowledge Practical Considerations<br />
for eCTD Submissions: Quality Overall Summary (QOS) for Marketing Applications, QOS eCTD/CMC<br />
v1.2.<br />
12. <strong>Health</strong> <strong>Canada</strong>, EMEA; Closer ties on medicines safety between European <strong>and</strong> Canadian regulatory<br />
authorities, 2008: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/announce_hcec-emea-sc_annonce-eng.pdf<br />
13. Release of Revised Guidance Document: Drug Name Review: Look-alike Sound-alike<br />
(LA/SA) <strong>Health</strong> Product Names: 31-Oct-2005: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/proj/alikesemblable/lasa-pspcs_post_market-comm_guidance-directive_2-eng.php<br />
14. Therapeutic Products Directorate (TPD) <strong>and</strong> Biologic <strong>and</strong> Genetic Therapies Directorate (BGTD)<br />
Protocol Safety <strong>and</strong> Efficacy Assessment Template-Clinical Trial Application (PSEAT-CTA), 2008:<br />
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-dem<strong>and</strong>e/templatesmodeles/notice_pseat_cta_avis_meiep_dec-eng.php<br />
15. Notice Regarding the Implementation of a Risk-Prioritized Periodic Safety Update Report Regulatory<br />
Review Pilot at <strong>Health</strong> <strong>Canada</strong>, including the adoption of International Conference on Harmonization<br />
(ICH) Guidance Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs -<br />
ICH Topic E2C, as of April 1, 2010: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-dem<strong>and</strong>e/guideld/vigilance/notice_avis_psur-rrp_pecr-rppv-eng.php<br />
16. <strong>Health</strong> <strong>Canada</strong> <strong>and</strong> FDA; Common Electronic Submissions Gateway (ESG) Work Plan - Proposal to<br />
explore <strong>and</strong> develop joint proposals to identify on-going systemic alignment mechanisms between the<br />
U.S. Food <strong>and</strong> Drug Administration (FDA) <strong>and</strong> <strong>Health</strong> <strong>Canada</strong> (HC):<br />
http://actionplan.gc.ca/eng/feature.aspmode=preview&pageId=456<br />
17. Non-electronic Common Technical Document (eCTD) Hybrid Pilot 27-Apr-12: http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic-dem<strong>and</strong>e/guide-ld/ctd/ectd/notice_non_ectd_hybrid_pilot_aviseng.php<br />
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