The BPOM has the Regulation Relating to Criteria and
Procedure Implementing Drug Registration of 2011 which suggests that BPOM can rely on information that it already possess. Another rule indicates that it is not required to submit clinical test
data for generics.
Meanwhile the US Special 301 review states that "The United States encourages Indonesia to provide an effective system for protecting against the unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products." For now Indonesia seems to comply with the unclear procedures in TRIPS, but it like many other countries is under pressure to change to a regulatory data exclusivity regime. This may not matter until some level of bilateral deal is needed.
Meanwhile the US Special 301 review states that "The United States encourages Indonesia to provide an effective system for protecting against the unfair commercial use, as well as unauthorized disclosure, of test or other data generated to obtain marketing approval for pharmaceutical and agricultural chemical products." For now Indonesia seems to comply with the unclear procedures in TRIPS, but it like many other countries is under pressure to change to a regulatory data exclusivity regime. This may not matter until some level of bilateral deal is needed.
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