Closer ties for EU & Australia in Orphan Drugs

syringes-and-vial-1028452-mThe European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have announced, at a collaboration meeting in London, that they are to share the full assessment reports related to marketing authorisations (MA) for orphan drugs. According to EMA executive director Professor Guido Rasi and Professor John Skerritt, national manager of the TGA, this will lead to greater scientific exchange when evaluating new medicines and accelerate access for patients in both regions. However it is important to note that the regulatory agencies will still reach their own conclusions about the suitability of each medicine to be authorised in their respective markets.

With a small number of patients affected worldwide and therefore a limited number of studies, collaborations like this are seen as vital to give greater access to new medicines and treatments. Work-sharing agreements such as this allow for information exchange in a number of areas: mutual recognition agreement on Good Manufacturing Practice (GMP); rationalise international GMP inspections of manufacturers of active substances; and becomes part of multilateral relationships involving other regulatory partners. Other examples of collaborations include the EMA and the US Food and Drug Administration (FDA) (since 2008) whereby the agencies encourage joint applications to the agencies for orphan drug designation; and then in 2012, its extension to Japan’s Ministry of Health, labour and Welfare (MHLW) and Pharmaceutical and Medical Devices Agency (PMDA).

Additionally this may have implications past orphan drugs after the meningitis B outbreaks at US universities late last year. The industry had criticized the FDA for slowly working through Novartis Bexsero vaccine application, even though the EMA has approved it, and no doubt together with patient/physician pressure also, we will see more global collaborations for regulatory agencies.