1. REGISTRATION SYSTEMS- UGANDA NDA Noel Aineplan
7TH VICH OUTREACH FORUM
DATE: 22ND JUNE 2016
VENUE: BRUSSELS, BELGIUM

2. Content of Presentation
Introduction
Drug Registration process
Activities supporting Registration
Ongoing initiatives
Challenges

3. AFRICA
Map of Africa showing the location of Uganda

4. Introduction NDA was established in 1993
The National Drug Authority And Policy Act(NDPA), Cap. 206, Laws of Uganda is the enabling law
Governed by an Authority(Board of Directors) appointed by the Minister of Health
Secterariat headed by the Executive Director carries out all activities

5. Introduction Major Business Processes: Inspectorate & Enforcement
Drug Assessment & Registration
Pharmacovigilance
Quality Control
Support functions- Legal ,PR, Finance, IT, Procurement etc

6. Scope of Drug Regulation
Scope of regulation is in the definition of a drug:
Any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes.
Products regulated:
Human Pharmaceuticals, Biologicals & Vaccines
Veterinary Pharmaceuticals, Biologicals & Vaccines
Nutritional substances
Herbal Medicines
Medical devices, Diagnostics and Sundries
Public Health Chemicals

7. Steps in REGISTRATION I Application for Registration Product dossier
Compliance
Additional information
and data
Corrective
actions
Assessment
Inspections
Steps in REGISTRATION
Retention, Variations , Pharmacovigilance , import and export control and post market surveillance
Product dossier
SMF

8. World Health Organization
Process flow
World Health Organization
10 January 2012
Application for Registration
Dossier, Samples & SMF
Information
requested
Applicant
Screening
Application accepted for assessment
GMP
Review of GMP Certification,
Inspection reports,
Site Master Files (SMF).
Information
requested
Information
requested
Corrective and
preventive actions
Assessment
Applicant
Inspection
Manufacturer
Accepted
Accepted
NDA Website
Final decision on Registration: CNF & Authority
Retention
Variations
Pharmacovigilance
Import & Export control
Post market surveillance
Listing on National Register
NDA website 8
PQP-overview & update January 2012

9. Receipt of applications
2 CDs (CTD format)- All documents are submitted in electronic format
Screening for completeness
Communication of missing information to applicant
Receipt of full application (+ samples) and assessment fees
Encoding (Assigning file numbers)
GMP (Submitting application for inspection)

10. Assessment steps 1st Assessment
2nd Assessment (Quality Assurance step)
Additional information request sent out to the applicant
Additional information received and assessed
Plant inspcted for GMP and approved - Valid for 3 years
At all stages, communication is made to the applicant.

11. Presentation to CNF and Authority
Products are presented to the Committee on National Formulary (CNF)
Recommendation made to the Authority (Board) for registration or deferment or rejection (The applicant has right to appeal)
Approval for Registration or Rejection by the Authority (Board)

12. Registration of product
Assigning registration numbers to the products approved for Registration
The approved products are included in the National register
Communication to the applicant on the decision of the Authority
NOTE: Commitment by NDA on Timeline for registration: 3 months from receipt of a complete application for registration.

13. Post Registration activities
These include:
Retention,
Variations ,
Pharmacovigilance ,
Import and Export Control,
Post Market Surveillance. QC

14. Importance of International Standards –VICH,DRAs
Encourages greater transparency and public availability of regulatory information
Promotes confidence and trust in the regulatory system
Applying the same principles to the consistent integration of the scientific reviews and decisions of other DRAs into the domestic review process.

15. Ongoing initiatives Development of the Uganda National formulary.
Harmonization of Registration in EAC and adopting Common Technical Document (CTD) format in registration medicines- IVPS.
Review and strengthen our registration guidelines in the areas of:
the Active Pharmaceutical Ingredient (API),
Pharmaceutical Development,
Efficacy (Clinical trials and Bioequivalence)
Increase in collaboration with International Bodies like VICH.

16. Ongoing initiatives (continued)
Consideration and utilization of reliable regulatory decisions of other agencies, institutions and experts without compromising independency and the objective of capacity building.
Utilization of risk analysis principles in:
assessment of applications for registration of products and amendments/ variations
Implementation of electronic system in DAR activities (evaluation, filing, communication)
Training of NDA Technical staff in Assessment of Medicines for Quality, Efficacy and safety.

17. Challenges Low staffing levels of Qualified Staff.
Integrated computer system.
Lack of adequate Storage facilities for Dossiers and Samples.

18. THANK YOU