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COMPETITIVE AND BUSINESS INTELLIGENCE
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AUSTRALIA TGA GUIDANCE DOCUMENTS |
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Guideline on the Evaluation of Medicinal Products in the Treatment of Primary Osteoporosis
This Guideline is intended to provide guidance for the evaluation of new medicinal products in the treatment of primary osteoporosis, principally in postmenopausal women but also in men. Full document...
Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells
The purpose of the Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells 2008 (‘the Guideline’) is to guide manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells. Full document...
Guidance on product changes in ELF3
This document has been developed to provide assistance to sponsors so that they are able to determine the regulatory impact and cost that making changes may have to currently Listed medicines. Full document...
Consensus Guidelines for Australian Clinicians for the use of anti-coagulants during heparin-based product shortages
On 22 April 2008 the Therapeutic Goods Administration (TGA) issued a recall of five batches of the anticoagulant Clexane (enoxaparin) due to the detection of an impurity in the affected batches. Full document...
Guidance on the GMP clearance of overseas medicine manufacturers - 16th edition (updated)
The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. Full document...
Guidance on the GMP clearance of overseas medicine manufacturers (15th edition revised)
The purpose of this guidance document is twofold. It is intended to provide information to sponsors and manufacturers on the acceptable form of evidence of GMP compliance for overseas manufacturers, and, outline how to submit such evidence to the TGA for assessment. It is not intended to provide a definitive list of the forms of evidence that are considered acceptable or unacceptable. Full document...
A guide to labelling drugs and poisons
This Guide has been prepared to assist manufacturers and packers of poisons to draft labels which comply with the SUSDP requirements as they exist on 1 January 2007. The information it contains is not complete nor is it intended to be the sole source of reference. Full document...
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