Celerion labs OKed by Brazilian regulators
Last week Celerion said the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilancia Sanitaria ANVISA) had certified operations at labs in its home city Lincoln, Nebraska and in Belfast, Northern Ireland.
Sites certified by ANVISA will have the review of their submissions expedited, potential reducing the research process. Furthermore, the organisation only accepts bioavailability/bioequivalence (BA/BE) work that is completely performed at certified sites,
The clearance therefore could be a real boon for Celerion according to CEO Susan Thornton, who explained its significance for the contract research organisations (CRO) business.
“By earning ANVISA certification to conduct early clinical studies and bioanalytical research for compounds destined for Brazil, Celerion is now able to better serve our clients’ growing needs in this high–growth, emerging market.”
The certification builds on work begun by former Celerion owner MDS Pharma, which first sought ANVISA approval for the facilities in October 2009 as a result of a client request.
Evidently this is a strategy that Celerion, which was acquired by Bain Capital and SV Life Sciences, still thinks is the right approach.
Clinical Research in Brazil
Brazil, whose pharmaceutical market is set to top $18bn (€12.3m) by 2012 according to most estimates, has one of the most rapidly expanding clinical research sectors. And Celerion is not the only CRO that has had its eye on Brazil’s market of late.
However the Celerion’s approach differs from peers like PRA, Covance and Chiltern which have established a physical presence in the country in recent years.
The clinical trials industry in Brazil began to emerge in 1996 when the country moved its rules governing trial more into line with International Conference on Harmonisation (ICH) guidelines and set a national bioethical committee, CONEP, to investigates institutional review boards (IRBs).
This process continued with the passing of resolution 39 in 2008, which enabled ANVISA and CONEP could review trial protocols in parallel process, as it occurs in Europe, potentially accelerating the process by months.
But, while these new rules have increased the amount of research conducted in Brazil, the ability to develop products for the market at sites in Europe and the US may prove to be an attractive option for international pharma firms.