Ectd/Ctd/Actd

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eCTD/CTD/ACTD Implementation in Southeast Asia Harv Martens ICH M2 JPMA Extedo, Inc. The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are…show more content…
Brumfield, Ph.D., Senior Vice President Worldwide Regulatory and Quality Assurance Pfizer Inc 12 HSA Risk Based Drug Evaluation System 270 Days 180 Days 60 Days 13 Singapore HSA Guidance • GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE – (http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medicines/guidelines.html (http://www hsa gov sg/publish/hsaportal/en/health products regulation/western medicines/guidelines html ) – 254 pages – Very detailed – Both CTD and ACTD • All submission documents in English only – D t il d guidance on t Detailed id translation f l ti from other th

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