It’s not a straightforward process for an overseas company or a new company to start its healthcare product business in a brand new market, there are a few steps to go through in order to gain entry to that local market.
Out of these steps, two of them are vital for making your products available for patients or customers in that local market – registration approvals with local regulatory authorities, and distribution of the products in the local market.
APPharma can assist your product commercialisation in local markets in Australia and China in these key areas.
Sponsor (Marketing Authorisation Holder)
For overseas companies, you not only need an regulatory consultant to make registration submissions on behalf of your business, but also you need a local legal entity (i.e. company) to apply for the product registrations with the regulatory authorities, and to hold your product registrations for product distribution in that country. This role is called a sponsor or marketing authorisation holder.
The local legal entity can be your own locally registered company, your local distributor or partner company. Very often, at the beginning stage of exploring the business in Australia or China, you may be in a situation that you do not have a local legal entity that can be the marketing authorisation holder for the product registration applications.
Product registration applications take some time, for example, a new medicine registration application could take up to 2 years for approval in Australia. The timeframe for an approval could be even longer if an overseas manufacturing site is involved, as extra time is required for GMP clearance or GMP certificate approvals before the medicine registration application can be lodged.
You also need some extra time to look for a good distributor or partner in the local market for your product distribution, and it takes time. Ideally, at the time of commercial negotiation, the local distributor or partner normally wishes that you have already got the product registered, and the product is ready to be launched commercially.
You could not afford to wait until the local legal entity is set then proceed to the product registration application.
APPharma and our allied partners can help you with this in Australia and China. We can act as a marketing authorisation holder for making product registration applications while you are looking for a distributor or preparing your commercial plan. This will save a lot of time for commercial operations.
Outlicence and Local Distribution
Other than your registration approvals with the local regulatory authorities, the other essential part is your product distribution for making the products available for patients or customers in the local markets.
APPharma and our allied partners have extensive connections with local industries in Australia and China (e.g. healthcare product companies, wholesalers and distributors). We can help you outlicense your products to local partner companies or find right channels for your product distribution at our local markets.
Overseas companies looking to invest in Australia or China often find it’s time-consuming to select a suitable and attractive product or project to invest. We have extensive experience, market information and network at local markets to help you identify and locate the investment opportunities, and we can assist your negotiation until the project is nailed and executed.
The investment opportunities include products, brands, projects, local manufacture and distribution, mergers and acquisitions, licensing opportunities, etc.