On November 16, the Senate approved the bill that seeks to establish quality control measures for drugs in the post-registration period. The initiative now passes to the Chamber of Deputies. You can access the bill by clicking here.
The proposal seeks to establish that, during the post-registration period, the health authority shall carry out periodic inspections to the holders of national or imported drug registrations, in order to evaluate quality deviations and aspects that may affect their therapeutic efficacy.
The inspections will be carried out on a scheduled or sporadic basis, in accordance with the regulations, always considering the following types of best-selling medicines or with the highest number of claims of the following categories: similar medicines; generic medicines; and reference medicines.