What approvals are required to import and market a new medicine in DR Congo under FDA-like regulation?

Hello. Bringing pharmaceuticals to the Democratic Republic of Congo market requires several key steps. First, importers must secure an import license from an authorized commercial bank and undergo a pre-shipment inspection by Bureau Veritas for shipments valued over ,500. While Good Manufacturing Practice (GMP) certification is officially required, enforcement is often inconsistent; a Certificate of Pharmaceutical Product (CPP) is a critical document. For quality control, initial screening is conducted locally using methods like the GPHF Minilab, with more comprehensive analysis performed at WHO-prequalified laboratories abroad. The entire process, from clinical trial application to market entry, is managed by the Congolese Pharmaceutical Regulatory Authority (ACOREP), which aims to provide a decision on clinical trial applications within 30 days of submission, following ethics committee approval. Failing to meet regulations, including the mandatory use of French on all documentation and likely labeling, can lead to significant sanctions, mirroring global standards that include product recalls and fines. The regulatory landscape is complex and requires careful navigation to ensure full compliance with all import and quality standards. Thanks