Transcription of GENERAL GUIDELINES FOR SUBMITTING …
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GENERAL GUIDELINES FOR SUBMITTING …
PHARMACEUTICAL REGULATORY AUTHORITY. GENERAL GUIDELINES FOR. SUBMITTING applications . FOR REGISTRATION OF A. MEDICINE. First Edition Table of Contents 1. Foreword 3. 2. Acknowledgements . 4. 3. Definitions and Interpretations .. 5. 4. Abbreviations and Acronyms . 7. 5. Introduction .. 10. PART IA GENERAL Information 13. PART IB Product Profile 17. PART IIA Bioavailability / Bioequivalence data 24. PART IIB Expert reports 24. PART III CHEMICAL AND PHARMACEUTICAL INFORMATION .. 25. PART IIIA Composition PART IIIB Development Pharmaceutics PART IIIC Control of the starting materials Active pharmaceutical ingredients (API). Excipient(s). PART IIID Packaging material (immediate packaging).
pharmaceutical regulatory authority general guidelines for submitting applications for registration of a medicine first edition
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