PharmOut employs a number of ex-Australian Therapeutic Goods Administration (TGA) inspectors as TGA consultants to ensure you get the best professional advice for your GMP and regulatory requirements. Our TGA consultants can help pharmaceutical, veterinary, medical device and IVD manufacturers solve quality assurance and validation issues, meet regulatory compliance, and acquire TGA certification and manufacturing or distributor qualification within Australia and or New Zealand.
If you are entering the Australian market for the first time, and have not yet found a Distributor, we can act as interim sponsors so you can obtain a TGA manufacturing certificate before listing or registering your drug or device on the Australian Register of Therapeutic Goods (ARTG).
Background to the TGA Regulations
The Australian Therapeutic Goods Administration (TGA) is Australia’s government agency in charge of medicinal products, this authority is given to them via the Commonwealth Therapeutic Goods Act.
The TGA regulates products used as or in therapeutic goods including:
- Over the counter (OTC) drugs
- Complementary medicines
- Biological products
- Topical products and devices
- Any goods claimed or implied to have therapeutic benefits
These products must be listed or registered with the TGA and included in the Australian Register of Therapeutic Goods (ARTG) is a computer database of all approved medicines and medical devices in Australia. If a product is included, listed or registered (they are 3 different things) on ARTG, the TGA issues a unique identification number, which must be displayed on all product labelling.
PharmOut’s TGA Consultants frequently navigate through the applicable TGA regulations and requirements and submit applications for product listing or registration to the TGA on behalf of manufacturers.
Our TGA Consulting Includes:
Liaison with the Regulatory Authorities and Support
Australian TGA regulatory affairs consulting – drug development, due diligence, dossier reviews, general advise, registrations and submission support.
New Chemical & Biological Entity, Biosimilars, line extensions, major variations, Orphan Drugs (designation applications, registration applications), variations and general maintenance & general maintenance including literature based submissions.
New entities, Biosimilars, line extensions, major variations & general maintenance.
New generics, bioequivalence study management & general maintenance.
New Medicine Applications, New Generic Applications, clone applications, Switching Applications, variations and general maintenance.
Medical Devices (Class I- III)
Our regulatory affairs consultants can advise on the documentation for inclusion.
Literature Based submissions
Literature search strategy development, pre-submission activities with TGA, literature sourcing and translations, pre-clinical &medical writing, dossier finalisation, dossier submission.
Dossier review-gap analysis reports
Review of dossier in accordance with Australian guidelines for registration.
Pre-Submission meetings and Liaison with the Authorities
Coordinate liaison with the TGA, coordinate briefing packages and attendance at meeting, general regulatory enquiries and liaison activities.
Clinical Trial support
Sponsorship/Marketing Authorisation applicant
We can act as your local Australian and New Zealand Sponsor until your marketing company or distributor agreements are in place.
eCTD & NeeS services
Electronic dossier documentation services, generation and compilation of hard copy for submission to TGA.
Pharmacovigilance outsourcing services
Pharmacovigilance gap analysis/ inspection-audit readiness reports +solutions, and pharmacovigilance outsourcing activities for Sponsors.