A bill to amend the Pharmaceutica Affairs Act, which grants a 6-year data exclusivity for incrementally modified new drugs that have obtained domestic marketing authorization, was reviewed during the plenary session of the Legislation and Judiciary Committee that was held on the afternoon of the 8th.

If approved by the committee, the bill will be passed during the plenary session tomorrow (Sept. 9) and be legislated.

The bill also suggest abolishing the drug re-review system and replacing it with a risk management plan (RMP).

In particular, there is great interest in the new provision in the bill that recognizes exclusive rights to new and incrementally modified