ASEAN GUIDELINE ON SUBMISSION OF …

2 GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION DATA FOR DRUG REGISTRATION 1. INTRODUCTION Process Validation is a means of ensuring that manufacturing processes are capable of consistently

  Guidelines, Drug, Process, Validation, Manufacturing, Registration, Submissions, Guideline on submission of, Guideline on submission of manufacturing process validation, Drug registration

FINAL DRAFT GUIDELINES ON SAFETY EVALUATION

ASEAN Guidelines for safety evaluation of cosmetic products - FInal Page 5 of 16 2. INGREDIENTS 11. Cosmetic ingredients are mostly chemicals and often mixtures of chemicals of synthetic origin

  Evaluation, Ingredients, Safety, Cosmetic, Safety evaluation, Cosmetic ingredients

ASEAN GUIDELINE FOR THE CONDUCT OF …

asean guideline for . the conduct of bioequivalence studies . adopted from the : “ guideline on the investigation of bioequivalence” ( european

  Guidelines, Studies, Investigation, Conduct, Bioequivalence, Guideline for the conduct of, Guideline for, The conduct of bioequivalence studies

Revised August 2017 - HSA

HEALTH SUPPLEMENTS GUIDELINES Revised August 2017 The information in this Guidelines shall be updated or revised from time-to-time. For any new, addition, amendments or deletion made to this Guidelines, please

  2017, Revised, August, Revised august 2017

THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) …

THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER PREAMBLE This ASEAN Common Technical Dossier (ACTD) is …

  Pharmaceutical, Organization, Human, Registration, Registration of pharmaceuticals for human use organization

APRIL 2016 - Home | HSA

This document is intended to provide general guidance. Although we have tried to ensure that the information contained here is accurate, we do not,

  2016, April, April 2016

MEDICAL DEVICE TECHNICAL SPECIFICATION - HSA

medical device technical specifications september 2012 health sciences authority – health products regulation group page 3 of 33

  Devices, Specification, Medical, Regulations, Technical, Medical device, Medical device technical specification

GUIDANCE NOTES ON GOOD DISTRIBUTION …

This guide is intended for those involved in the storage, transportation and distribution of starting materials and medicinal products, collectively referred to

  Notes, Guidance, Guidance notes

Aminorex Amfepramone Amobarbital Alprazolam …

7/24/2017 Singapore Statutes Online - 329 - Health Products (Therapeutic Products) Regulations 2016 Loprazolam Lorazepam Lormetazepam Mazindol Medazepam

GN-01-R3 Guidance on the Application of Good …

MEDICAL DEVICE GUIDANCE GN-01: Guidance on the Application of Good Distribution Practice for Medical Devices Revision 3 October 2011

  Devices, Applications, Good, Practices, Medical, Distribution, Application of good distribution practice for medical devices

ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …

1 ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT Version 4.0 Update revision : May 2012 Document Control Version Date 1.0 thJuly 2004 (8 ACSQ PPWG Meeting; Bangkok)

  Guidelines, Study, Drug, Stability, Asean, Asean guideline on stability study of drug

ICH Q5C Stability testing of Biotechnological / …

4 ICH Q5C - Stability testing of Biotechnological / Biological products ICH guidelines on stability • Q1A - Stability testing for new drug substances and products (R2 - 2003)

  Drug, Testing, Biological, Stability, Q5c stability testing of biotechnological, Biotechnological, Q5c stability testing of biotechnological biological, On stability

BIOFARMA EXPERIENCE WITH ASEAN CTD - …

•Established in Jakarta (ASEAN Secretariat), December 2016 • Guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier

  Guidelines, Asean

Stability Testing of Pharmaceutical Products in a …

Regulatory Feature The ASEAN developments meant a decision would have to be made on whether to amend the WHO guidance A decision was eventually taken to split

  Product, Pharmaceutical, Testing, Stability, Asean, Stability testing of pharmaceutical products