Healthy Skepticism Library item: 19700

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Publication type: Government Document

Australian Government
TGA reforms: A blueprint for TGA’s future
2011 Dec
http://www.tga.gov.au/pdf/media-2011-tga-reforms-111208.pdf

Abstract:

The Therapeutic Goods Administration (TGA) was established to safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods. It does this through the application of the Therapeutic Goods Act 1989 (the Act). The TGA is a Division of the Commonwealth Department of Health and Ageing.
The TGA applies risk-based regulatory processes to therapeutic goods before they are marketed and monitors products once they are on the market. Additionally, it assesses the suitability of medicines and medical devices for export from Australia.
It also regulates manufacturers of therapeutic goods to ensure they meet acceptable standards of manufacturing quality. It has a team of inspectors that audit manufacturing facilities around the world to ensure that products supplied in Australia are of high quality.
The TGA works with consumers, health professionals, industry and its international counterparts in order to effectively regulate increasingly complex medicines and medical devices resulting from rapid scientific and medical developments.
In order to ensure that the TGA continues to fulfil its public health role and is able to meet community expectations within a complex therapeutics regulatory environment, several major reviews have been undertaken across various therapeutic regulatory areas. These have included:
· the review to improve transparency of the Therapeutic Goods Administration;
· ·
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public consultations on the regulatory framework for advertising therapeutic goods;
the Working Group on Promotion of Therapeutic Products;
the Auditor-General’s report on Therapeutic Goods Regulation: Complementary Medicines;
an informal working group examining the regulation of complementary medicines and reasons for low compliance rates;
public consultations on the medical devices regulatory framework; and
· · the Health Technology Assessment Review.
The reviews were undertaken as part of the commitment to open government.
In response to the various reviews, the Government has drawn this work together into a comprehensive package of reforms to be progressed in stages. The reforms will enhance the TGA’s current processes to ensure that the regulatory framework within which it operates remains able to adapt with flexibility to new scientific
TGA reforms: A blueprint for TGA’s future
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developments and emerging community expectations. They will improve the Australian community’s understanding of the TGA’s regulatory processes and decisions and enhance public trust in the safety and quality of therapeutic goods.
These reforms will also ensure that the TGA is better aligned to the central principles of the National Medicines Policy, by effectively implementing plans to inform the community of its role in providing timely access to the therapeutic goods that Australians need, and that they meet appropriate standards of quality, safety and efficacy.
These reforms are grouped under the following themes to ensure the Government can effectively monitor progress and achievements:
· communications and stakeholder engagement;
advertising of therapeutic products; complementary medicines; medical devices; and
· · · · promotion of therapeutic products.
In providing its response the Government has indicated where implementation can begin immediately and where further consult