The Bioavailability and Bioequivalence Laboratory of the National Center for Quality Control (CNCC) —run by the
National Health Institute (INS)— has become the first laboratory in Peru authorized to develop the analytical stage of drug bioequivalence studies, the
Ministry of Health (Minsa) reported on Sunday.
The audit consisted of a visit by Digemid inspectors, who interviewed the staff and visited each of the areas involved in the process to carry out in vivo therapeutic equivalence studies.
In addition, they assessed the requirements provided by Law No. 29459 (Law on pharmaceutical products, medical devices and sanitary products) and Supreme Decree No. 024-2018, which regulates the interchangeability of drugs.
This authorization is of great importance for the CNCC, since it will allow assessing the safety and efficacy of generic drugs, as well as their interchangeability with original drugs.
Likewise, it highlights the quality of professionals and health technicians who work at the CNCC.
(END) NDP/LIT/RMB
Published: 6/20/2021