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Good Clinical Practice - CRC

Fourth Edition Malaysian Guideline for good Clinical Practice National Pharmaceutical Regulatory Agency (NPRA) Ministry of Health Malaysia Malaysian Guideline for good Clinical Practice , 4th Ed Page 2 Malaysian Guideline for good Clinical Practice 4th Edition First Edition 1999 Second Edition 2004 Third Edition 2011 Fourth Edition 2018 Adapted from the ICH E6: good Clinical Practice Malaysian Guideline for good Clinical Practice , 4th Ed Page 3 Malaysian Guideline for good Clinical Practice 4th Edition Published by: National Committee for Clinical Research (NCCR) National Pharmaceutical Regulatory Agency (NPRA) - secretary Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia. Telephone : 03-7883 5400 Homepage : Ministry of Health Malaysia Perpustakaan Negara Malaysia Cataloguing-in-Publication Data Malaysian Guideline for good Clinical Practice .

The revision is intended to increase the efficiency and quality of clinical trials with the ... A license in Form 4 in the schedule of The Control of Drugs and Cosmetics Regulations of 1984, authorizing the licensee to import any product for purposes of ... the object of ascertaining its safety and/or efficacy. The terms clinical trial and ...

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