Introduction
DICOL, the Collegiate Board of Directors of ANVISA (Agência Nacional de Vigilância Sanitária), oversees pharmaceutical regulations, medical devices, and public health policies in Brazil. It plays a crucial role in approving Regulatory resolutions, ensuring compliance, and expediting market access for healthcare products.
Key Responsibilities of DICOL
1. Regulatory Decision-Making
DICOL enforces RDCs (Resoluções da Diretoria Colegiada) covering:
- Pharmaceutical approvals
- Medical device regulations
- Clinical trials and food safety
2. CADIFA Certification
DICOL oversees CADIFA (Certificate of Suitability of Active Pharmaceutical Ingredient Dossier), ensuring API manufacturers comply with Brazilian Regulatory standards.
3. Regulatory Reliance & Global Alignment
DICOL fast-tracks approvals by recognizing assessments from agencies like the FDA, EMA, and TGA, reducing market entry barriers.
4. Post-Market Surveillance
DICOL enforces pharmacovigilance, device monitoring, and recalls, safeguarding product quality and patient safety.
Impact on Brazil’s Healthcare Industry
DICOL’s Regulatory oversight ensures:
- High-quality pharmaceuticals & medical devices
- Accelerated market entry for global companies
- Regulatory harmonization with international standards
- Robust public health protection
DICOL plays a pivotal role in Brazil’s pharmaceutical and medical device Regulatory landscape, supporting compliance, market expansion, and patient safety.
Looking to navigate Brazil’s complex Regulatory environment? Our Regulatory experts can help you ensure smooth market entry and compliance. Contact Us today to streamline your approvals.