Product development process of therapeutic formulations is often complex or simple depending on the type of medicine and regulatory requirements. In general, all processes include the following steps:
- Concept
- Feasibility Research
- Clinical Research
- Development
- Proof of Concept
- Final Formulation
- Data Generation
- Regulatory Submissions
TGA classifies medicines within 3 main categories and the cost of development and regulatory approvals depends on what category the proposed product can be classified into.
Prescription Medicines
Prescription Medicines or Schedule 4 medicines generally requires complex drug development pathways, including human clinical studies or bioequivalence studies. We can assist with certain generic medicine development.
Over-the-counter Medicines (OTC)
Most of the generic medicines and pharmacy/retail products with a higher level of therapeutic claims will fall within this category. R2 Pharma Solutions can assist with formulation design, data generation and regulatory submission.
Listed Medicine (Complementary Medicines)
These are mostly supplements, traditional herbal medicines and other lower-level therapeutic indications. 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.
