Europe and Switzerland to share confidential information on swine flu medicines
This article was originally published in Scrip
The European Medicines Agency (EMA) and Switzerland's regulator, Swissmedic, are to exchange confidential information on pandemic H1N1 medicines. The agreement follows Switzerland's request for more co-operation between the two agencies.
In January Switzerland asked the European Commission's Directorate General for Health and Consumers for more cooperation between the EMA and Swissmedic. Both agencies subsequently recognised a "specific and urgent need for an interim co-operative arrangement" for swapping information that may be used in the context of the influenza A(H1N1) pandemic.
The two agencies therefore signed an agreement last week permitting them to exchange confidential scientific and technical information that may be exempt from public disclosure. This should help the agencies to guarantee the safety, quality, efficacy and post-authorisation follow-up of medicines used in the pandemic. During the course of the agreement, the information exchange could become part of the agencies' regulatory and scientific processes before and after approval, says the EMA.
Any information exchanged – which could include commercial, trade secret, personal privacy, law enforcement or international operational information – will remain confidential.
A mutual recognition agreement (MRA) has been in place since 2002, obliging the two agencies to mutually recognise one another's manufacturing authorisations and good manufacturing practices (GMP) inspections. The scope of the MRA was extended in January 2010 to include mutual recognition of GMP inspections of advanced medicinal products, and in November 2008 to include GMP inspections of active pharmaceutical ingredients.