Europe and Australia to Work Together to Regulate Orphan Medicines

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The European Medicines agency has announced plans to strengthen their collaboration with Australia’s Therapeutic Goods Administration in the field of rare diseases.

The two agencies agreed in a meeting on the 4th of April to share full assessment reports relating to the market authorisation of orphan products, whilst maintaining their independence to come to their own decision about the orphan drugs

The collaboration means that the EMA and TGA will recognise the quality of the other’s evaluation and assessment through a mutual recognition agreement, covering good manufacturing practice for medicines and manufacturers.

Global collaboration on orphan medicines and rare diseases is particularly important in view of the small number of patients worldwide and the need for the limited number of studies performed to benefit patients regardless of where they live

It is hoped that this collaboration will speed the pace at which orphan drugs become available for patients. For manufacturers who apply simultaneously to both the EMA and the TGA, they could well enjoy a reduction in clinical research requirements, such as the duplication of clinical trials to satisfy individual regulators.

This could well be a sign of things to come as many have been calling for greater collaboration between regulators (especially between the FDA and EMA) when it comes to the evaluation of important and much needed medical products.

After the meningitis B outbreaks at US universities late last year, many saw the FDA as dragging their feet in approving Novartis Bexsero vaccine in order to prevent further outbreaks. There are suggestions that this delay, which saw a further 2 universities hit with meningitis B, could have been avoided had the FDA worked more closely with the EMA who had already approved the vaccine.

Within the field of orphan drugs though, this collaboration between the EMA and TGA should hopefully see treatments arrive sooner for patients, costs drop slightly for developers, and so hopefully a drop in price for patients.

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