Kenya Drug Product Registration

MOH

Ministry of Health

MOH Website

https://www.health.go.ke/

Regulatory Authority

Pharmacy and Poison Board(PPB) 

Regulatory Website

https://web.pharmacyboardkenya.org/

Local Authorized Representative Required

Yes

Drug Registration Process

A New Drug application

1. Two dully filled application forms (Original and Duplicate) and an electronic copy (a summary of the dossier contents) in MS Word on a CD-ROM of modules 1 and 2 only including their supporting documents – see Annex I
2. Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis.

iii. An original Certificate of Pharmaceutical Product (WHO Format) on official papers of the issuing competent drug regulatory authority.

• A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.
• Nonrefundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not yet inspected by PPB.

Applications for Registration Renewal

Applications for registration renewals must be submitted with the following documents at least three months prior to the current registration’s expiration date:

1. A properly completed application for a registration renewal.
2. The Batch Manufacturing Record (BMR) of a genuine batch produced no more than six months prior to the application’s submission.

iii. Send in PSURs, or periodic safety update reports.

iii. The evidence of generics’ interchangeability as described in Module 5.

1. Any additional specifications that the Board decides to impose.
2. Batch certificates of analysis and three (3) samples of the smallest commercial pack(s) from the same batch.

vii. A site master file if the product is produced at a facility or plants that PPB has not examined and approved.

Registration Process

1.Submission of Application- The Application for the New drug registration is submitted in the eCTD Format.

2.Evaluation Process- The evaluation of applications is done on a first in first out (FIFO) basis unless the product meets the fast-track criteria as set out in this guideline.

3.Pre-Registration lab analysis of product sample- All medications in the samples will be examined, and the application must be accompanied by a certificate of analysis from a recognized quality control laboratory in Kenya or the surrounding area. Using the analytical method supplied by the applicant, a laboratory analysis of the samples will be performed in accordance with the claimed internal or pharmacopoeia specifications.

4.Verification of compliance to current Good Manufacturing Practices (cGMP)- Before a product is registered, PPB will, if the new application is from a new production site, inspect the site or take other action to confirm that the facility complies with the most recent good production Practices Regulations and/or guidelines. A factory cannot register a product unless it complies with cGMP. Following the inspection, the observations’ specifics will be included in a comprehensive report that will be a component of the assessment procedure.

5.Approval for the New Registration – A summary of recommendations of evaluation, laboratory analysis and GMP status reports will be presented before the Committee on Drug Registration for consideration and making final recommendations for granting or rejecting registration of the product.