Information Required from Local Manufacturers Before Commencement of New Pharmaceutical Product Manufacturing

Regulatory Authority

National Drug Authority (NDA)

Yes

Generic Drugs, Biologics, New Drugs

6-12 months

5 Years

6 Months

The local pharmaceutical manufacturer is required to provide the National Drug Authority (NDA) with written notification of their intent to produce a new pharmaceutical product. The following information should be included:

1. Product Details

• Name and description of the product, including physicochemical and biological properties of the drug substance.
• Master formula and details of product components, including the reasons for their inclusion.
• For products containing herbal raw materials, provide an impurity profile and a heavy metal test report.
• Information on the compatibility of different components, including the drug substance with excipients and excipients with each other.

2. Manufacturing Protocols

• Master batch manufacturing, master batch packaging, and master batch testing protocols for the product.
• A list of equipment intended for use in manufacturing and quality control.
• Clear description of the entire manufacturing process, including necessary controls. Provide a manufacturing process flow chart indicating stages with in-process controls.

3. Quality Control and Outsourcing

• Choice and rationale for the selection of the container-closure system and packaging materials, considering the intended use of the drug product.
• Artwork or actual specimens for packaging and labelling materials.
• Validation protocols for process, analytical methods, and cleaning validation.
• Information about premises and support systems, including pharmaceutical water system, air handling system, compressed air system, and stability determination system.

4. Outsourced Activities

If the local manufacturer lacks the capacity for a specific quality control test, it should be outsourced to a competent quality control laboratory as per Chapter 7 (Outsourced Activities) of the NDA GMP guidelines (Document No. INS/GDL/001). The contract for outsourcing should be submitted to NDA.

By providing this comprehensive information, the local manufacturer ensures transparency and compliance with regulatory requirements, facilitating the NDA’s assessment of the manufacturing process and the quality control measures in place for the new pharmaceutical product.

3.1 Submission of Information

At the completion of the process validation phase, the manufacturer must submit the following information to NDA for a minimum of three consecutive batches:

1. a) Executed batch manufacturing records;
2. b) Batch packaging records;
3. c) Batch testing records;
4. d) Reports of process validation, cleaning validation, and analytical method validation (if a non-pharmacopeial analytical method is used);
5. e) Finished product samples (refer to Appendix 1 for Sampling Plan).

3.2 NDA Assessment

NDA will assess the submitted information for accuracy and completeness.

3.3 Evaluation and Testing

NDA shall conduct an evaluation of the information submitted and perform testing on samples obtained from the three consecutive batches. The manufacturer will be informed of the assessment results.

3.4 Pre-Marketing Authorization

If the analysis results demonstrate that samples from all three consecutive batches meet the required specifications and any raised queries are addressed by the manufacturer, NDA will grant pre-marketing authorization. This authorization allows the local manufacturer to proceed with production and sale on the Uganda market, including the first three consecutive batches.

3.5 Production Permission

Upon pre-marketing authorization, the manufacturer is permitted to proceed with accelerated and long-term stability studies.

3.6 Registration Application

The manufacturer should apply for registration of the product after producing not more than six batches or within six months from the date of pre-marketing authorization, whichever comes first.

3.7 Stability Studies Submission

If no significant changes are observed in the finished product stability studies at accelerated and long-term conditions for at least six months, data covering a minimum of six months should be submitted to NDA along with the product dossier in CTD format.

3.8 NDA Evaluation for Registration

NDA will evaluate the product dossier in accordance with the NDA Guidelines on Submission of Documentation for Marketing Authorization of a Pharmaceutical Product for Human Use, Doc. No. DAR/GDL/004. The product will be registered, and marketing authorization granted if all submitted information complies with the registration guidelines.

3.9 Market Entry and Registration

A new pharmaceutical product cannot be introduced to the market after six months from the date of pre-marketing authorization or beyond the production of the sixth batch (including the first three consecutive batches), whichever comes first, unless it has been officially registered by NDA.