REGULATORY AFFAIRS

On average, it takes 12 years and $1.4 billion of research investment to bring one new medicine to the market. But each new medicine still needs to prove its worth to our local regulation agency, the Therapeutic Goods Administration.

That's where our Regulatory Affairs team comes in. The team ensures the company has collected enough of the right information for the government agency – the TGA – to approve a new medicine. Making sure a medicine is effective and has the right level of safety to use in Australia is not a simple task. And the journey doesn't end there with a medicine's approval; it's just the start. The Regulatory Affairs team works in collaboration with the TGA to ensure new information about each medicine is provided to them so that this can in turn be made available to doctors and patients – so the right treatment choices can be made.

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This site is intended for Australian residents. MSD is a member of Medicines Australia. MSD recommends patients always seek the medical advice of their healthcare professional.