Uganda : Drugs
Clinical Trial Data Requirements
Clinical trial data requirements are outlined in Guidelines for conduct of clinical trial.
The checklist (see Annex 2 of the Guidelines) contains the following required items for a Clinical Trial Application (CTA):
-Proof of payment.
-Applications for import and/or export of materials (if required).
-Clinical Trial Application Form.
-Participant Information Leaflet and Informed Consent.
-Certificate of GMP manufacture of the trial medicine or other evidence of manufacture quality, safety and consistency.
-Package Insert/s for trial medicines.
-Certificate of GMP manufacture of the placebo-if appropriate.
-Evidence of accreditation of the designated Laboratories or other evidence of GLP and assay validation.
-Insurance Certificate specific for the trial in consultation with NDA.
-Signed and completed Declarations by all Investigators.
-Approval of Ethics Committees for the Protocol.
-Full, legible copies of key, peer-reviewed published articles supporting the application.
-Sample of the label for the imported products.
-Letter of authorization from the manufacturer/product owner.
-Pharmaceutical Data on dosage form.
-Other supporting documents.
CTA must be in English.
Clinical Trial Estimated Timeline
The guidelines for clinical trials states that it is an average of 30 working days from the time a complete application is received by the Drug Information Department in NDA.
Clinical Trials Import Authorization
A Clinical Trial License is required to import a product for purpose of clinical trial. This is granted by the NDA. More details are outlined in Section 4 ("Importation and Release of Investigational Product") in the Guidelines for conduct of clinical trial.
Clinical Trial Costs
Phase I: $2500
Phase II or III (New investigational product): $4000
Phase II or III (Known product): $3000
Phase IV: $1000
A full list of NDA fees is posted here.
In-Country Manufacturing Requirements
Uganda follows Good Manufacturing Practices (GMP). Guidelines are available here.
For a clinical trial application, a copy of the current insurance certification is required which provides evidence that each member of the Investigation team is covered by malpractice insurance for the trial.
For a clinical trial application, a copy of the current insurance certification is required which provides evidence that each member of the Investigation team is covered by malpractice insurance for the trial. The sponsor is required to provide compensation or indemnity if there is a trial-related serious injury, disability, or death.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
32 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
Requirements for registration are outlined in Guidelines on the registration of pharmaceuticals for human use in Uganda, which were put into effect on July 1st 2013. Uganda only accepts CD-ROM submission of registration dossiers in the Common Technical Document format addressed to The Executive Secretaty/Registrar, National Drug Authority.
The application has five modules: Administrative and product information, Overview and Summaries, Quality, Non clinical study reports, and Clinical study reports. Detailed information on these modules can be found in the guidelines.
An application can only be submitted by the license/patent holder, manufacturer, distributor authorized by the manufacturer/license/patent holder, or an authorized Local Technical Representative (LTR) of the manufacturer/license/patent holder. Applicants need to Ugandan residents or appoint an NDA authorized agent in Uganda. The NDA needs to be notified of agents by submitting an appointment letter and original copy of power of attorney.
All documents are to be submitted in English.
Product Registration Costs
First registration for human/veterinary products: $1250
Annual retention of registration for human/veterinary products: $500
A full list of NDA fees is posted here.
Post Registration Labeling Requirements
Labelling information can be found in Appendix 4 of the Guidelines on Submission of Documentation for Marketing Authorisation of a Pharmaceutical Product for Human Use, which can be found here.
Post Registration Pharmacovigilance Requirements
The Drug Information Department (DID) oversees pharmacovigilance. In 2005, the DID created the National Pharmacovigilance Center (NPC). The NPC is a member of the WHO Adverse Drug Reaction (ADR) monitoring center. The NPC trains health workers on monitoring and reporting ADRs, develops pharmacovigilance guidelines, develops ADR forms and collects reports, and maintains an ADR database.
According to the Guidelines for the Conduct of Clinical Trials, Principle Investigators must report all SAEs to Institutional Review Committees and sponsors with copies to the NDA no later than 7 days following receiving notice. Full information should be submitted to the NDA no later than 15 days following request.
Section 10.2 of the National Guidelines for Research Involving Humans as Research Participants contains additional guidelines on reporting adverse events. It defines categories of serious adverse events, and states that prompt reporting is required for the following situations:
"a. All serious adverse events irrespective of relationship to the health related intervention;
b. All unexpected events of greater than moderate severity irrespective of relationship to health related intervention;
c. All events associated with protocol violations irrespective of severity and relationship to health related intervention;
d. When criteria for stopping or pausing a study as stipulated in the protocol are met;
e. Any event mandated by regulatory authorities;
f. Any event stipulated in the protocol as reportable to the regulatory bodies."
September 25, 2014.