FDA, Poland Sign off on Agreement to Exchange Regulatory Information
Posted 22 October 2013 | By
The US Food and Drug Administration (FDA) has quietly released the text of a new "Confidentiality Commitment" meant to facilitate the exchange of regulatory information between FDA and Poland's Główny Inspektorat Farmaceutyczny (GIF) and Medical Devices and Biocidal Products of Poland (Urzedowi Rejestracji Lekow, Produktow Leczniczych i Wyrobow Medycznych, or URPLWMiPB).
Such agreements are relatively common, and FDA has signed ones similar in structure and intent with dozens of international regulatory bodies, including the European Medicines Agency (EMA), Health Canada, and the regulators of Australia, Brazil, South Africa and most independent EU member states.
In its newest agreements, signed in April 2013 but only made publicly available on 22 October 2013, FDA and Polish regulators agree to collect and keep confidential-that is, exempt from public disclosure under the Freedom of Information Act (FOIA)-any non-public information provided to US regulators by Poland.
In addition, related information, such as the owner of the information or the subject of the information being provided, will not be made public unless explicitly allowed by GIF or URPLWMiPB. [Editor's note: That may be the most convoluted acronym I've ever come across in my life.]
FDA will also be tasked with providing Polish regulators with information pertaining to any legal changes in the US that could negatively impact the arrangement, such as new legislation or efforts to obtain information through the judicial process. FDA has said it will take "all appropriate legal measures" to prevent the disclosure of information in such cases, it says in the posted agreement.
The reverse of all commitments made by FDA are also binding on GIF and URPLWMiPB, which will in turn share, receive and protect information provided by FDA.
FDA Agreements (GIF) (URPLWMiPB)
Polish Agreements (GIF/FDA) (URPLWMiPB/FDA)