Ensure Compliance of Your Medicine with TGA Consultants
Therapeutic Goods of Administration (TGA) is the government authority responsible for regulations of pharmaceutical products such as Over The counter medicines, complementary/Listed medicines and prescription medicines. They also regulate Medical Devices and other therapeutic goods that falls within the definition of “Therapeutic Goods”.
Streamline Your Regulatory Journey with Trusted TGA Consultants
At R2 Pharma Solutions experts in the regulations of TGA can assist you with complete process starting with selecting the correct regulatory pathway for your idea. Then heading into providing cost and timeframe associated with product registration. Through our expertise in wide area including chemical formulations, quality management systems and regulatory we can provide a comprehensive service navigating your project in the right pathway.
TGA classifies medicines within 3 main categories and complexity depends on what category the proposed product. Our consultants possess the expertise, experience, and proven track record of success in assisting pharmaceutical companies in registration of all categories of medicines.
Prescription Medicines
Generally requires complex drug development pathway, including human clinical studies or bioequivalence studies.
Over-the-counter Medicines (OTC)
Most of the generic medicines and pharmacy/retail products with higher level of therapeutic claims will fall within this category. R2 Pharma Solution can assist with formulation design, data generation and regulatory submissions.
Globally Harmonised System (GHS) and Australian Dangerous Goods (ADG) Regulations:
Preparation of safety data sheets that comply with Australia and other countries that hold GHS regulations for hazardous chemicals.
AICIS – Industrial Chemical Regulations:
Formally known as NICNAS, all chemicals that are not regulated by the TGA or APVMA are regulated under AICIS. All industrial chemicals must be reviewed against the regulation of AICIS. We can assist in reviewing your product against AICIS compliance. We can also assist with new chemical categorisation or assessment applications with AICIS.
We specialise in New Zealand regulations as well and can assist with harmonised launch for Australia and New Zealand. We specialise in New Zealand EPA, Medsafe, ACVM and MPI regulations.
Listed Medicined (Complementary medicines)
These are mostly supplements, traditional herbal medicines and other lower-level therapeutic indications. These products have approval number as AUST L. Sunscreens are also categorised within this pathway depending on various factors. This is also the least regulated pathway out of the three categories. R2 Pharma Solutions can assist with formulation development, required data generation and regulatory approvals. We will also assist with label preparation as per TGA guidelines.
FAQs
Yes, medicines can be manufactured overseas if the manufacturer has correct GMP certifications. You must apply for GMP clearance before you can submit product registration. R2 Pharma Solutions can provide assistant to Australian sponsor or overseas manufacturer in getting TGA approval for their manufacturing site.
Yes, there are number of exclusions and exemptions specific in TGA regulations. This depends on your product type, therapeutic claims etc. R2 Pharma Solutions can provide guidance on exemptions and special pathways for medicine registration, ensuring you have a clear understanding of the options available to you.
This is where our expertise in regulation can assist you with the determination. TGA cannot act as consultant for you and will not provide the direct advice you need. We provide determinations after careful consideration of your product specification and TGA regulations whether it falls under Food Regulations or Medicine regulations.
Yes, complementary medicines are regulated by the TGA. This is the least complex of 3 medicine pathways. R2 Pharma Solutions specialises in the regulatory compliance of complementary medicines, ensuring your products meet the necessary requirements.
For complementary medicine cost of registration can be anywhere from $2000 AUD to $6000 AUD depending on product type and specifications. However, cost of the entire process can only be determined after preliminary assessment of your product. We can conduct this check without any charge to the client and provide an estimate. Cost for other medicine categories can only be ascertained after proper assessment of product to determine the category and data requirements.