Increased Transparency in Generic Drug Approvals
New rules aim to increase transparency in the generic drug approval process. Pharmaceutical companies will find it easier to verify if their generic drugs are identical to original ones, potentially speeding up access to more affordable alternatives. Citizens may benefit from quicker access to generic medications.
Key points
Generic drug manufacturers can request information on original drug composition to ensure their versions are identical.
If a generic differs from the original, the agency must disclose which ingredients and quantities are different.
The agency cannot reverse its decision on drug identity unless the original drug was withdrawn for safety reasons or an error was identified.
Clear guidelines on how the agency will assess generic drug identity are to be issued within one year.
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