As of June 2025, ANVISA has implemented a strategic change that demonstrates its commitment to optimizing regulatory processes in the pharmaceutical and medical device sectors.
What changed in practice?
BEFORE: The renewed Good Manufacturing Practice Certificate (CBP) validity started from the publication date, creating temporal discontinuity.
NOW: The renewal validity starts exactly on the last day of the current certification, ensuring perfect continuity.
Practical example:
- Current certification: expires on 12/31/2025
- Renewal published: 10/31/2025
- New rule: Validity starts on 12/31/2025 (not on 10/31/2025)
Key benefits:
For companies:
- Full utilization of the validity period (complete 2 or 4 years)
- Greater predictability in regulatory planning
- Elimination of unnecessary overlaps
For the regulatory system:
- Process standardization and transparency
- Reduction of questions about validity periods
- ANVISA Consultation Portal optimization
Impact on the Consultation Portal
An important change: renewals published before the current certification expires will not appear on the Portal until they are effectively in force, avoiding confusion and ensuring clarity in consultations.
Industry reflection
This change reflects Brazilian regulatory maturity, prioritizing operational efficiency and legal certainty. For regulatory affairs professionals, it represents further evidence of the importance of continuously monitoring ANVISA updates.
How is your company preparing for these regulatory changes?
💬 Share your experience in the comments about how these changes impact your processes
Need regulatory affairs consulting? Contact me to discuss how I can help your company navigate these changes.
📎 Reference:
ANVISA. Anvisa altera forma de contagem da validade do Certificado de Boas Práticas. Available at: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2025/anvisa-altera-forma-de-contagem-da-validade-do-certificado-de-boas-praticas. Accessed: Aug. 2025.
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