NICM Health Research Institute (NICM HRI) is a focal point for innovation and independent research offering a full range of commercial testing and product development services for complementary and integrative medicine, pharmaceuticals, and veterinary products.
As a full service research-intensive institute, from the bench to the bedside (preclinical, clinical and translational), we advance evidence-based analysis focusing on product quality, safety, efficacy, and effectiveness.
Our world-class researchers and state-of- the-art facilities at Western Sydney University offer novel, innovative and creative solutions for technical challenges faced by industry.
TGA Licensed Laboratory
NICM HRI is one of only two university laboratories licensed by the Australian Therapeutic Goods Administration (TGA) to undertake and provide certificates of analysis for herbal products in line with regulatory requirements.
Our fully equipped laboratories support industry with independent and accredited testing and research services, including:
- Authentication of botanical identity of raw herbs and identification of active ingredients.
- Assay and potency testing – Herbals, Active Pharmaceutical Ingredients and compounded pharmaceutical preparation in all dosage forms.
- Analytical method development and validation.
- Stability testing – physical and chemical; batch to batch quality assurance.
Our preclinical research capabilities extend to various novel in vivo and in vitro models.
Utilising a wide range of instruments and advanced techniques such as Nuclear Magnetic Resonance Spectroscopy and High Performance Liquid Chromatography systems, we provide a strong scientific foundation for product development.
NICM HRI’s fully equipped laboratories support industry with independent and accredited testing and research services, including:
- Pre-formulation studies, excipient compatibility, physicochemical/chemical purity.
- Formulation studies, dosage form design.
- Extraction, isolation and quantification of herbal biomarkers.
- Herbal synergy and combination optimisation.
- Bioassay guided fractionation.
- Cell based antioxidant, anti-inflammatory, anti cancer, vascular health, neuronal and antimicrobial assays.
- Molecular targets studies underlying clinical effects of herbal medicines.
- Pharmacokinetic studies and bioavailability of herbal medicine.
- Herb-drug interaction studies.
- In vitro and in vivo toxicity testing.
Essential to the development of new interventions, clinical trials research verifies a product’s benefits and targeted indications, along with its limitations and precautions.
NICM HRI can assist in developing your research program by providing a range of clinical research services, including:
- Clinical trials – ICH compliant, phase II and III.
- CRO services, including protocol development, trial design.
- Clinical bioavailability studies.
- Cardiovascular and neurological function testing using technologies such as electroencephalography (EEG), SphygmoCor and computer based cognition testing.
Therapeutic goods include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.
NICM HRI provide a range of regulatory services specialising in complementary medicines (also known as 'traditional' or 'alternative' medicines) include vitamin, mineral, herbal and aromatherapy products. Our services include:
- Ingredient and product formulation reviews and level of registration required.
- Product formulation for TGA compliance.
- Evidence packages and reviews for therapeutic indications/claims.
- Development and submission of listing applications to the TGA.
- Label development and review.
- Liaising with the TGA.
- Stability protocol development.
- Compliance of marketing materials and advertising clearance.
Assessed Listed Medicines
A key reform legislated in the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (opens in a new window) was the establishment of an additional pathway for the regulation of intermediate-risk medicines.
The three pathways are broadly defined as follows:
- AUST-L (existing pathway – listed): Listing in the ARTG following self-declaration by the sponsor regarding safety, quality and efficacy.
- AUST-L(A) (new pathway – assessed listed): Listing in the ARTG following self-assessment of the safety and quality and a TGA assessment for efficacy and product label check.
- AUST-R (existing pathway – registered): Registration in the ARTG following full TGA assessment of safety, quality and efficacy.
NICM HRI is well positioned to assist with regulatory support and compliance with the assessed listed pathway by means of:
- Ingredient and product formulation reviews for AUST-L(A) compliance.
- Liaising with the TGA.
- Clinical trial protocol development.
- Clinical trial completion.
- Development and submission of AUST-L(A) applications to the TGA.
For more information, please visit the TGA website (opens in a new window) or contact (opens in a new window) our commercial services team.