Author: John McEwan
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
Book Description
A History of Therapeutic Goods Regulation in Australia
Author: John McEwan
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
Book Description
Publisher:
ISBN: 9780980422900
Category : Drugs
Languages : en
Pages : 170
Book Description
Therapeutic Goods Administration (TGA).
Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
The Therapeutic Goods Administration (TGA) is a Division of the Department of Health and Ageing, Australia and is responsible for administering the provisions of the Therapeutic Goods Act. This site provides information about the regulations and control of prescription drugs, over the counter medications and medical devices within Australia. Also included are links to information on issues associated with [agricultural and environmental] chemicals, complementary medicines and gene technology.
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
Book Description
The Therapeutic Goods Administration (TGA) is a Division of the Department of Health and Ageing, Australia and is responsible for administering the provisions of the Therapeutic Goods Act. This site provides information about the regulations and control of prescription drugs, over the counter medications and medical devices within Australia. Also included are links to information on issues associated with [agricultural and environmental] chemicals, complementary medicines and gene technology.
Therapeutic Goods Act 1966
Author: Australia
Publisher:
ISBN: 9780644130271
Category : Capsules (Pharmacy)
Languages : en
Pages : 20
Book Description
Publisher:
ISBN: 9780644130271
Category : Capsules (Pharmacy)
Languages : en
Pages : 20
Book Description
Container Examination Facilities
Author: Australian National Audit Office
Publisher:
ISBN: 9780642808110
Category : Customs administration
Languages : en
Pages : 159
Book Description
"The Therapeutic Goods Administration (TGA) is responsible for the regulation of the manufacture and supply of medicines, including complementary and over-the-counter medicines, in Australia, to protect public health and safety... The objective of this audit was to assess the TGA's regulation of non-prescription medicinal products. In particular, it addressed the systems, procedures and resource management processes used to: confirm new manufacturers comply with requirements for the manufacture of non-prescription medicinal products; monitor manufacturers and medicines to ensure requirements continue to be met; and manage non-compliance." -- from the Summary, p. 13.
Publisher:
ISBN: 9780642808110
Category : Customs administration
Languages : en
Pages : 159
Book Description
"The Therapeutic Goods Administration (TGA) is responsible for the regulation of the manufacture and supply of medicines, including complementary and over-the-counter medicines, in Australia, to protect public health and safety... The objective of this audit was to assess the TGA's regulation of non-prescription medicinal products. In particular, it addressed the systems, procedures and resource management processes used to: confirm new manufacturers comply with requirements for the manufacture of non-prescription medicinal products; monitor manufacturers and medicines to ensure requirements continue to be met; and manage non-compliance." -- from the Summary, p. 13.
Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Therapeutic Goods Act 1989
Therapeutic Goods Regulation
Author: Australian National Audit Office
Publisher:
ISBN: 9780642812070
Category : Alternative medicine
Languages : en
Pages : 197
Book Description
"Growth in the use of complementary medicines has been attributed to concerns about adverse effects from conventional drugs and the desire to pursue alternative treatments. These medicines are also widely considered to offer gentler means of managing chronic conditions associated with greater life expectancy. However, there are potential risks as well as benefits in the use of all medicines, including complementary medicines, and this is recognised in Australia's National Medicines Policy (NMP)."--p. 13.
Publisher:
ISBN: 9780642812070
Category : Alternative medicine
Languages : en
Pages : 197
Book Description
"Growth in the use of complementary medicines has been attributed to concerns about adverse effects from conventional drugs and the desire to pursue alternative treatments. These medicines are also widely considered to offer gentler means of managing chronic conditions associated with greater life expectancy. However, there are potential risks as well as benefits in the use of all medicines, including complementary medicines, and this is recognised in Australia's National Medicines Policy (NMP)."--p. 13.
TGS Information Kit:An Introductory Guide to the Regulatory Processes for Registering and Listing Medicines in Australia
Therapeutic Goods Regulations in Force Under the Therapeutic Goods Act 1989
Therapeutic Goods Act 1989
Author: Australia
Publisher:
ISBN: 9780644474122
Category : Capsules (Pharmacy)
Languages : en
Pages : 16
Book Description
Publisher:
ISBN: 9780644474122
Category : Capsules (Pharmacy)
Languages : en
Pages : 16
Book Description