EU and Swiss regulators strengthen ties with confidentiality agreement
The European Medicines Agency (EMA) signed the confidentiality agreement with the Swiss Agency for Therapeutic Products (Swissmedic) in order to share non-public information on the safety, quality and efficacy of drugs - both on the market and in development – and builds on the close relationship between the agencies.
“EMA and Swissmedic have collaborated for many years in the context of the Mutual Recognition Agreement signed in 2002 and their cooperation during the 2009/2010 H1N1 pandemic,” EMA spokesperson Eleni Fistikaki told in-Pharmatechnologist.com.
While this has brought close cooperation on Good Manufacturing Practice (GMP), she said this latest agreement may bring opportunities for further resource savings on other types of inspections.
“Cooperation is expected to further align communication to protect public health and to improve efficiency in areas of common interest [through] the exchange of regulatory information and sharing of expertise and best practice to improve safety, quality and efficacy of medicines and the elimination of unnecessary duplication to improve competence in the human and veterinary areas, both in Switzerland and the European Union (EU).”
Closer relations between the agencies will also improve timely patient access to new drugs, she added: “By sharing information and perspectives in specific therapeutic areas, under concurrent review in both agencies, the two regulators aim to increase alignment and support patients’ access to new treatments.”
Swissmedic spokesperson Peter Balzli agreed that such an agreement “helps regulators to deal more effectively with the common challenges they face in supervising a globalised industry with complex supply chains,” but told us the major reason for signing the concord was to facilitate the exchange of information between the two agencies and any financial or resource savings would be a bonus.
“Speaking for Swissmedic, it may improve our capability to apply a provision in the Therapeutic Products Act, which refers to the consideration of scientific assessments of other well-established regulators in the decision-making process.”
