[Ip-health] Malaysia data exclusivity

[Sean Flynn]

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New Straits Times

FTA: Malaysia imposes terms on data exclusivity for US pharmaceuticals





By : BERNAMA



PETALING JAYA, THURS:

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.