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The Therapeutic Goods Act 1989 is an Act of the Commonwealth of Australia which regulates therapeutic goods. The Act is administered by the Therapeutic Goods Administration (TGA), which is part of the Commonwealth Department of Health. [1] The statutory framework set out in the Act is supplemented by the Therapeutic Goods Regulations 1990 and ...
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In most jurisdictions, therapeutic goods must be registered before they are allowed to be ...
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. [4] As part of the Department of Health and Aged Care, the TGA regulates the safety, quality, efficacy and advertising in Australia of therapeutic goods (which comprise medicines, medical devices, biologicals and certain other therapeutic goods).
In New South Wales, poisons are proclaimed in the Poisons List by the Poisons Advisory Committee, under the authority of the Poisons and Therapeutic Goods Act 1966 (NSW). NSW legislation refers to S2 as "medicinal poisons", S3 as "potent substances", S4 as "restricted substances" and S8 as "drugs of addiction".
The department is responsible for programs such as Medicare and the Pharmaceutical Benefits Scheme, and agencies such as the Therapeutic Goods Administration and the National Health and Medical Research Council. The department is responsible to parliament through the Minister for Health and Aged Care, and is supported by four assistant ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
We will be monitoring the matter closely, and reserve all rights and remedies as discussed below. We also remain concerned about recent amendments to sections 26B(1)(a), 26C and 26D of the Therapeutic Goods Act of 1989. Under these amendments, pharmaceutical patents owners risk incurring significant penalties when they seek to enforce their ...
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.