IBSA in the World

Special IBSA around the world: Oceania


Oceania is an entirely unexplored region and it is precisely with the goal of expanding to new markets that IBSA has recently set up a business development team. The company intends to begin marketing its products in new countries and is currently focused on recruiting strategic partners that can provide support in both planning and operations.

Today, IBSA is present in Australia with only one product, a medical device used in urology, but the business development team is working on a new contract in the field of fertility.

Australia is an extremely attractive market but registering drugs and medical devices there is fairly complex. In many cases, benefiting from the know-how of specialists is crucial. For example, our affiliate IBSA Farmaceutici Italy has worked with the Italian Trade Agency, which promotes foreign trade and Italian exports, to assess potential companies interested in collaborating with IBSA on the Australian market, with a particular focus on potential partnerships in food supplements and intra-articular products.

Australia has a specific reimbursement system for drugs and medical devices that is somewhat similar to the European Union’s. Moreover, the Australian Therapeutic Goods Administration (TGA) – the medicine and therapeutic regulatory agency of the Australian government – is updating the classification of medical devices to increasingly harmonise its regulations with the European Union’s. Australia is also a participant in the Medical Device Single Audit Program (MDSAP), together with the United States, Canada, Japan and Brazil. Under this program, certification entities recognised and accredited by the regulatory authorities in the five participating countries may conduct a single regulatory audit of a medical device manufacturer’s quality management system to verify that it meets the dictates of good manufacturing practices (GMPs).

Daniela Mariano Sofo, Senior CMC & RA Manager (Regulatory Affairs Department) notes that “IBSA has registered medical devices in Australia that, unlike now, previously entailed leaner, faster registration processes thanks to mutual recognition with European products. On the other hand, in New Zealand, the simpler, more direct registration process is still available. We are beginning to consider the possibility of also registering our pharmaceutical products in Oceania, although the procedures are longer and more complex than those for medical devices. In any case, for both pharma and non-pharma products, it is still necessary to find local regulatory support, which distributors might be able to offer if they have their own regulatory affairs department. Alternatively, local consultancy firms can advise us on national requirements.”