If you’re looking to supply your products to the Australian market but are unsure on the surrounding regulations, PharmOut’s TGA regulatory affairs consultants can support you every step of the way. We are familiar with the TGA’s framework for managing and classifying the vast range of products that come under the definition of therapeutic goods (as pictured below):
Products falling into the therapeutic goods category must be approved and registered by the TGA in the Australian Register of Therapeutic Goods (ARTG) before any manufacturer or supplier can supply or export those products to or from Australia. Products must be registered if they are:
- classed as ‘higher risk’ and have been assessed as meeting the requirements for quality, safety and efficacy and/or performance
- classed as a ‘lower risk’ medicine, biological or medical device application which has been validated.
The processes and requirements for each product’s approval varies across and within the different categories of medicines and medical devices. This variation is reflected in the different levels of quality documentation required to support each application and it can be tricky knowing which level of standard to comply to for each product.
We offer consulting services for companies wishing to register pharmaceutical, complementary medicine or dietary supplements with the Australian TGA, for sale within Australia.
Our Regulatory Affairs services include:
- regulatory strategy
- regulatory compliance for over the counter products
- regulatory compliance for prescription medicine
- regulatory compliance for product development
- regulatory compliance for medical devices
- reviewing chemistry/pharmacy, preclinical and clinical texts
- technical writing and preparation of the Common Technical Document (CTD)
- gap analysis, preparation and submission of the application to the TGA
- preparation of documents for clinical trial approval
- preparing marketing authorisation applications and submissions
- post-approval regulatory compliance
- submitting dossiers and paying fees on your behalf
For drug registrations, our TGA regulatory affairs consultants can assure validation of the dossier, receive questions from the TGA, and prepare suitable responses on your behalf. Our consultants can also co-ordinate the submission of responses and provide expert reports/overviews.
Need help with TGA submission, regulatory requirements, determining your product category, or just have a few questions you want to ask? Contact us here. We can also provide TGA consultants to suit your requirements.
If you want to read more about TGA regulatory matters, why not have a look at our blogs?