The US Food and Drug Administration (FDA) is offering Israel the opportunity to sign a secrecy agreement between the two countries’ food and drug authorities, a move that would allow Israeli firms to make their contacts with the FDA more efficient.
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Dr Mark B McClellan, the US Commissioner of Food and Drugs, made the announcement in Tel Aviv this week at the IsraPharm 2004 conference on life sciences. The offer by the US official surprised the participants of the conference. Representatives of Israeli firms commented that they had not expected the FDA to be willing to cooperate with Israeli regulators, reports Haaretz.
The FDA is responsible for approving the sales of food products and pharmaceuticals in the US, and Israeli firms who wish to enter the American market must first receive FDA approval for all the products in those areas. According to Dr McClellan, the secrecy agreement would allow the two sides to exchange information, for example on the safety of food manufactured in Israel. He said that in the past year the FDA has signed a confidentiality agreement with the EU, Switzerland and Canada. “Such agreements include joint work plans that detail the areas in which both sides agree to reveal confidential information.”
The situation today is that each Israeli company deals with the FDA on an individual basis in order to receive approval. If, for example, some of these activities were handled by the Health Ministry, “that would enable various ministry offices to share part of the information they have accumulated with all Israeli companies, thereby making their application procedures with the FDA easier,” the report notes.
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