3 de junho de 2019

BRAZIL NEWS: GMP Certificate for drug products: companies can request earlier inspection dates

Faster response to applications. Inspections scheduled for the second half of the year can be brought forward.

The waiting list for international inspections to get the Good Manufacturing Practice (GMP)Certificate for drug products no longer exists. Companies whose risk assessment point to the need for inspection are being contacted to schedule their inspection within approximately two months from the date of submission. On average, inspections are taking place five months after the application is submitted.

The results show that Anvisa’s response to requests for certification has become quicker, beating the agency's six-month target. This faster process contributes to the mission of guaranteeing that only quality drugs can be imported, and helps the Brazilian population access new therapies in less time.

Companies wishing to bring their inspection forward may e-mail Anvisa's Office of Medicines and API Inspections (GIMED), at gimed@anvisa.gov.br. We have the operational capacity and availability to set new dates to July and August.