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Uganda
Guidelines for Introducing a Locally Manufactured New Pharmaceutical Product on the Ugandan Market
These guidelines, issued by the National Drug Authority (NDA), provide requirements and procedures for the introduction of new pharmaceutical products manufactured within Uganda.
The framework is grounded in the National Drug Policy and Authority Act (Cap. 206) and the Licensing Regulations (2014), ensuring that locally produced medicines meet international standards of Good Manufacturing Practice (GMP) before being placed on the Ugandan market.
It details the pre-manufacturing and post-manufacturing assessments conducted by NDA, stability studies, batch sampling requirements, and the criteria for granting pre-marketing authorization. Local manufacturers are expected to comply with GMP, conduct validation studies, provide full manufacturing and quality documentation, and submit product dossiers in CTD format for final registration.
By enforcing these standards, the NDA aims to protect public health while supporting local pharmaceutical production and improving access to safe, effective, and quality medicines in Uganda.
Use Cases
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Local Pharmaceutical Manufacturers: Guidance on dossier preparation, GMP compliance, process validation, and stability studies before launching new products.
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Regulatory Authorities (NDA): Standard framework for assessing applications and ensuring product safety, efficacy, and quality before marketing authorization.
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Policy Makers & Legal Teams: Reference tool for aligning national policies and regulations with international best practices in medicines regulation.
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Healthcare Professionals: Assurance that newly introduced local medicines meet required quality and safety standards.
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Academia & Researchers: Resource for training on regulatory requirements, GMP, and dossier submission for product registration.
Key takeaways you'll learn
