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EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs
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The European Medicines Agency (EMA) has strengthened its collaboration with its equivalent in Australia on orphan drugs for rare diseases.

EMA's executive director Guido Rasi and Prof John Skerritt of the Therapeutic Goods Administration (TGA) announced this week that both organisations will share full assessment reports related to the marketing authorisations of these orphan products,

It also means that if the same marketing authorisation is submitted by a company to both the EMA and the TGA at the same time, the agencies will be able to engage in a scientific exchange to evaluate the medicine, although each will still be able to make an independent decision on authorisation.

The EMA said: 'The agreement will reinforce collaboration and work-sharing between the two regulatory authorities and will contribute to accelerating access to new medicines for patients with rare diseases in Europe and in Australia.'

The EMA and the TGA have existing relationships in other areas, including good manufacturing practice (GMP) for medicines and related international inspections.

The World Health Organization (WHO), the US FDA, EU Member States and the European Directorate of the Quality of Medicines and Healthcare (EDQM) are also involved in the inspection collaboration, agreed in 2012.

The EMA's efforts to improve its working partnerships with other regulators also includes a recent agreement with the FDA to hold regular meetings on respective pharmacovigilance issues.

Orphan drugs are also becoming an increasing priority for the European regulator, which has introduced greater fee reductions for pharma companies submitting treatments for rare disease and giving companies submitting orphan drugs the opportunity to received parallel advice related to health technology assessment.

Article by
Thomas Meek

8th April 2014

From: Regulatory

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