Experience with Parallel Review/Licensure
In 2008, Kenyan regulators participated in a joint review of the Phase III protocol for the RTS,S malaria vaccine, which was organized through AVAREF.
For an application to conduct HIV/AIDS vaccine research, investigators must submit a concept paper to the Kenya HIV/AIDS Vaccine Subcommittee. After getting a response, the investigator must simultaneously submit proposals to the Pharmacy and Poisons Board (PPB) and National Council for Science and Technology (NCST).
There are additional ethical guidelines for HIV/AIDS vaccine trials listed on the Kelin Kenya website.
Clinical Trial Data Requirements
Applications are submitted to the Clinical Trial Unit of Division of Medicines Information and Pharmacovigilance of the Pharmacy and Poisons Board. The clinical trial application form can be found here. Applications must be submitted in both paper (4 bound copies) and electronic format (PDF) on a CDR/flash disk. Requirements are listed in the "Guidelines for Applications to Conduct Clinical Trials in Kenya":
-Patient Information leaflet and Informed consent form.
-Investigators Brochure/Package inserts or Investigational Medicinal Product Dossier (IMPD).
-GMP certificate of the investigational product.
-Signed investigator(s) CV(s).
-Financial declaration by Sponsor and/or PI.
-Signed Declaration by Sponsor or PI.
-Indemnity cover and Insurance Certificate for the participants.
-Copy of favourable opinion letter from the local Institutional Review Board (IRB) and Ethics committee.
-Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable.
-A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate and is not false or misleading.
-Where the trial is part of an international study, sufficient information regarding the other participating countries and the scope of the study in these countries.
-For multicentre/multi-site studies, an addendum for each of the sites should be provided upon initial application.
-Registration with the clinical trial registry.
-Payment of $1000 US (or equivalent in Kenya Shillings) application fee.
Clinical Trial Import Authorization
Permission to import investigational products is pending approval to conduct a clinical trial. When the research protocol is approved, a request to import the product can be submitted to the Trade Department of the PPB. An investigator must submit a Clinical Trial Import License and/or evidence of delivery to the approved investigator or trial center.
Clinical Trial Estimated Timeline
The decision of the PPB (Approval, Request for Additional Information or Rejection) will be communicated to the applicant within 30 days of the receipt of a valid application.
Clinical Trial Costs
US$ 1000 (or equivalent in Kenya Shillings) per proposal.
In-Country Manufacturing Requirements
The manufacturer is responsible for applying to register a pharmaceutical product for manufacturing. There are six conditions for manufacture registration:
1. Manufacturer must comply with Good Manufacturing Practices (GMP).
2. A foreign manufacturer must have a local agent with blanket power of attorney.
3. A free sale certificate from the country of origin or a certificate of a pharmaceutical product.
4. Separate application for each product.
5. Payment of fees.
6. Certificate issued is valid for five years.
More information on manufacturing registration is available here.
Clinical trial guidelines require indemnity coverage for study participants.
Clinical trial guidelines require insurance coverage for study participants.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
5 clinical trials approved from June 2012 to June 2014.
Product Registration Estimated Timeline
According to the PPB's official guidelines for new drug registration, fast- tracked registration (locally manufactured and priority medicines only), post approval variation and renewal of registration applications will be processed within 90 working days of receiving the applications. In general, donated drugs, drugs procured for the public sector, and essential drugs are eligible for fast-track registration.
New applications will be processed within 12 months of receiving the application. The applicant has 6 months to provide additional data (if requested).
Product Registration Data Requirements
1) Administrative information.
2) Chemical, Pharmaceutical, Non-Clinical and Clinical Overviews and Summaries.
3) Chemical and Pharmaceutical Documentation.
4) Non-Clinical Reports for New Chemical Entities Only.
5) Clinical Study Reports.
I) Application for Registration of a Drug – (Form 1, revised 2010).
II) Model Stability Report for Active Pharmaceutical Ingredients (APIs).
III) Model Stability Report for Finished Pharmaceutical Products.
IV) Summary Product Characteristics.
More details are available here.
Product Registration Costs
Application for registration of a pharmaceutical product:
-Imported in to Kenya - US$ 1000.
-Fully manufactured in Kenya - US$ 500.
Application for renewal of registration of a pharmaceutical product:
-Imported into Kenya US$ 500.
-Fully manufactured in Kenya US$ 300.
Post Registration Labeling Requirements
Section 41 of the Pharmacy and Poisons Act has outlines labelling for medicines containers.
Post Registration Pharmacovigilance Requirements
Beginning in April 2013, pharmacovigilance reporting in Kenya is completely digital. Kenya is the first country in the world to use a digital reporting tool for pharmacovigilance based on mobile technology. The pharmacovigilance electronic reporting system is accessible here.
The Pharmacy and Poisons Board guidelines for the national pharmacovigilance system is available here.
October 19, 2015.