For any pharmaceutical company seeking market entry in Uganda, the registration of a medicinal product is the critical first step. 
While the process may seem daunting, a clear understanding of the National Drug Authority’s (NDA’s) requirements can help streamline approval and avoid costly delays.

The National Drug Authority (NDA) Registration Framework.

The legal framework for registration of medicines in Uganda is established under the National Drug Policy and Authority (Registration of Drugs) Regulations, 2021, developed pursuant to Sections 35 and 64 of the National Drug Policy and Authority Act, Cap. 198. These Regulations form the statutory basis for the marketing authorization of all medicines, vaccines, and other immunological products before sale or distribution in Uganda. They define application procedures, dossier requirements, and conditions for registration, renewal, suspension, or cancellation of certificates, and legally require that all submissions demonstrate safety, efficacy, and quality supported by relevant technical data.

In line with these Regulations, NDA has developed six key guidelines to support industry compliance, freely accessible on the website: https://www.nda.or.ug/human-medicine-guidelines/

• Pharmaceutical products (PAR/GDL/004 Rev.3, 2023): Establishes Uganda’s CTD-based dossier structure aligned with ICH and WHO frameworks (Modules 1–5). This harmonization enables direct use of global dossiers with limited localization to administrative information.
   
• Veterinary pharmaceuticals (PAR/GDL/036 Rev.0, 2023): Provides CTD-based requirements with added veterinary-specific considerations—withdrawal periods, target animal safety, residue depletion, AMR risk, and environmental and user safety assessments.
   
• Human vaccines (PAR/GDL/021 Rev.1, 2023): Addresses vaccine-specific attributes such as antigen and adjuvant characterization, cold-chain stability, and use of vaccine vial monitors. It also requires data for lyophilized and multi-dose presentations, bridging studies for combination vaccines, and post-approval immunogenicity and safety monitoring.
   
• Biotherapeutic products (PAR/GDL/016 Rev.1, 2023): Provides requirements for originator biologics, emphasizing manufacturing control, comparability, viral safety, stability, and immunogenicity, supported by quality, non-clinical, and clinical evidence.
   
• Similar biotherapeutic products (PAR/GDL/017 Rev.1, 2023): Defines Uganda’s biosimilar pathway based on WHO TRS 1004 and ICH Q5E, using a stepwise comparability approach—analytical, non-clinical, and clinical—to establish similarity in quality, safety, and efficacy with the reference product.
   
• Imported herbal medicines (DAR/GDL/029 Rev.0, 2020): Sets dossier and quality requirements for imported herbal products, including GMP certification, validated analytical data (e.g., chromatographic fingerprints), standardization of extracts, and control of contaminants such as heavy metals and pesticides.

Important to note: At least two pieces of product samples must accompany the registration application, and must meet NDA labelling standards, including storage instructions, active ingredients, and expiry details. The NDA’s target review timelines are 210 working days for full assessments and 90 working days for fast-track priority medicines.

Common Pitfalls

• Submitting incomplete dossiers: Applications often miss mandatory components such as GMP certificates, CPPs, stability data, or product samples.
• Non-compliant labelling: Labels frequently omit essential details or fail to meet NDA’s prescribed requirements, leading to delays in approval.
• Neglecting pharmacovigilance plans for post-market safety: Many applicants fail to include Risk Management Plans or designate a local contact person responsible for pharmacovigilance (LCPPV), which are mandatory for post-market safety compliance.
• Inconsistent product information: Discrepancies between the Summary of Product Characteristics (SmPC), patient leaflet, and container label often trigger technical queries or dossier re-submission.
• Expired supporting certificates: Submissions accompanied by expired GMP, CPP, or Free Sale Certificates
• Improper dossier formatting: Failure to follow the CTD module structure,
• Lack of validated analytical methods: Missing validation reports or non-standard test procedures.
• Failure to appoint a local agent: Foreign manufacturers that omit a notarized power of attorney for their Ugandan representative
  
  The Role of Regulix Consultancy
  
  Regulix assists companies align dossiers with NDA’s expectations, conduct gap analyses, and manage communications with regulatory officers. This avoids back-and-forth queries that often delay approvals. Our recent support package to manufacturers has typically involved the customisation of international/global dossier data into a NDA-compliant dossier framework to support local submission, followed by local regulatory liaison for purposes of submission of responses for additional information to support eventual registration. We further support companies to meet NDA GMP requirements and co-develop plans to meet GMP compliance and resolution of GMP non-conformances sustainably.
  
  Medicine registration in Uganda requires detailed preparation and a solid understanding of NDA guidelines. Companies that invest in professional regulatory affairs support will save time, reduce risk, and bring safe, quality medicines to Ugandan patients more efficiently.
  
  Contact Regulix today to align your regulatory submissions with the standard requirements of the regulator