FTA: Malaysia imposes terms on data exclusivity for US pharmaceuticals

New Straits Times, Malaysia

FTA: Malaysia imposes terms on data exclusivity for US pharmaceuticals

19 April 2007

Bernama, Petaling Jaya - Malaysia has set some conditions in agreeing to the U.S. request for data exclusivity (DE) for new pharmaceutical products in the bilateral free trade agreement (FTA) negotiations, Health Minister Datuk Seri Dr Chua Soi Lek said today.

Among the conditions: DE is for a five-year period effective from the time a product obtains a DE from its country of origin, and it can only be granted by Malaysia’s National Pharmaceutical Control Bureau (NPCB).

“The U.S. wants DE for five years for pharmaceutical products and three years for new clinical information,” he said.

“The Malaysian government has adopted a stand, approved by the Cabinet last year, that for new products the DE should only be for five years and should be given at the same date as at the country of origin.

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