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Unit of study_
PHAR7815: Regulation of Complementary Medicines
2023 unit information
This unit provides a detailed overview of the processes involved in the development, production and regulation of complementary medicines and medicinal cannabis products devices (with a focus on herbal and nutritional supplement products). In this unit, students will learn about fundamental processes related to complementary medicine and medicinal cannabis production including the regulatory framework, relevant policies and ethical implications (including evidence claims) governing this industry, good cultivation practice (GCP) and manufacturing practice (GMP) and quality standards, submission of product dossiers requirements as well as internationalisation of complementary medicine and medicinal cannabis products (e.g. regulation in Asia and other key areas for export). Students will gain an understanding of the processes and guidelines involved in registering complementary medicine and medicinal cannabis products with the Therapeutic Goods Administration (TGA) in Australia and will be able to assess the level and quality of evidence to support the manufacturer's claim. This unit is suitable for postgraduate students who are working in or interested in entering the complementary medicine or medicinal cannabis development, manufacturing, and regulation sector.
Unit details and rules
Managing faculty or University school:
Pharmacy
| Code | PHAR7815 |
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| Academic unit | Pharmacy |
| Credit points | 6 |
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Prerequisites:
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None |
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Corequisites:
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None |
| Prohibitions:
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None |
| Assumed knowledge:
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Students will be expected to have a relevant health care, health science or science related undergraduate qualification or experience working in this sector |
At the completion of this unit, you should be able to:
- LO1. Explain the regulatory framework for the assessment of safety, quality and efficacy of complementary medicines and medicinal cannabis products
- LO2. Discuss the key criteria for adherence to good manufacturing practice (GMP) standards
- LO3. Develop high quality complementary medicines and medicinal cannabis regulatory documentation
- LO4. Evaluate the ethical aspects of complementary medicines and medicinal cannabis marketing with a special focus on assessing the level and quality of evidence to support a complementary medicines product claim
- LO5. Critically appraise the key differences between regulatory frameworks for complementary medicines and medicinal cannabis within the global context.
Unit availability
This section lists the session, attendance modes and locations the unit is available in. There is a unit outline for each of the unit availabilities, which gives you information about the unit including assessment details and a schedule of weekly activities.
The outline is published 2 weeks before the first day of teaching. You can look at previous outlines for a guide to the details of a unit.
There are no availabilities for this year.
Modes of attendance (MoA)
This refers to the Mode of attendance (MoA) for the unit as it appears when you’re selecting your units in Sydney Student. Find more information about modes of attendance on our website.
