ขั้นตอนในการลงทะเบียนยาใหม่กับหน่วยงานกำกับดูแลของสาธารณรัฐประชาธิปไตยคองโกมีอะไรบ้าง?

Hi. In the Democratic Republic of Congo (DRC), the Congolese Pharmaceutical Regulatory Authority (ACOREP) oversees marketing authorization. Applicants must submit a comprehensive dossier with details on manufacturing, quality control, clinical data, and labeling, adhering to WHO and ICH standards. For clinical trials, proof of registry enrollment and Ethics Committee approval are mandatory. ACOREP aims to decide on clinical trial applications within 30 days. The timeline for full marketing authorization is not specified but follows a multi-step evaluation. Fees are established for clinical trial applications, with a Phase III/IV study for a non-resident sponsor costing $3,000 USD. While local clinical data is not explicitly mandated for all marketing authorizations, any trial in the DRC requires ACOREP and EC approval. Post-market surveillance is managed by the National System of Pharmacovigilance, which monitors adverse events and ensures drug safety after market entry. This system includes data collection, risk assessment, and regulatory compliance to maintain the benefit-risk balance of pharmaceutical products available to the public. Thanks