Please login to the form below

Not currently logged in
Email:
Password:

EU and Australian regulators collaborate on rare diseases

EMA and Therapeutic Goods Administration to share reports for orphan drugs
EMA-Logo

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

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
W2O Group

W2O Group is an integrated marketing agency with expertise in brand and digital strategy, creative development and communications services. We...

Latest intelligence

Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...
NHS medicines optimisation milestone
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare Consulting Team, explore the implications of Adalimumab’s recent European patent expiry...

Infographics