In Kenya, the regulatory authority that deals with pharmaceuticals, medical devices and the practice of pharmacy is PPB.  The Ministry of Health oversees to ensure PPB regulates the industry.  They provide the manpower for the same.  Although the counties are devolved, only PPB regulates the entire nation. 

There is often an overlap in regulation that interferes with effective and efficient regulation in the industry.  Other entities also attempt to regulate medical devices.  This amounts to double regulation, which simply means that licenses/permits are taken from separate authorities.  This essentially means multiple fees.  The Ministry of Health and states that PPB is the only guiding/regulatory authority.  Unfortunately, on the ground, the scenario is different.

The PPB ensures that regulations surrounding pharmaceutical manufacturing, wholesaling/distributing, retailing is maintained.  PPB undertakes the responsibility of inspecting the site of manufacturing of all drugs registered in Kenya. In order to register a drug in Kenya, there is an application that must be submitted.  Each application is a collection of documents that provides details about the drug ie., the dossier.  The dossier should include the following information: (forms and guidelines can be found in the Annex).

General Information

Module 1: Administrative Information

Module 2: Chemical, Pharmaceutical, Non-clinical and Clinical Overviews and Summaries

Module 3: Chemical and Pharmaceutical Documentation

Module 4: Non-Clinical Reports for New Chemical Entities Only

Module 5: Clinical Study Reports

The dossier annexes must include the following information:

Annex 1: Application for registration of a drug (Form 1, revised 2010)

Annex 2: Model Stability Report for Active Pharmaceutical Ingredients (APIs)

Annex 3: Model Stability Report for Finished Pharmaceutical Products

Annex 4: Summary of Product Characteristics

If the drug is being registered for the first time in the Kenyan market, one must submitted 2 dully filled application forms with 3 commercial packs from a batch with certification of analysis, in addition to inspection certificate from PPB of the manufacturing plant, and fee. 

Fees vary for an imported product (USD 1000) and that of a locally manufactured product (USD 500).  For retention of a product the fees are less for an imported product (USD 500) and locally manufactured product (USD 300).:

 Table X: Current Fees for pharmaceutical registration application

The timeline attached with processing of applications depends on whether the drug is a priority medicine and locally manufactured, or if it is otherwise.  The first group of applications take approximately 90 working days to be processed.  Other applications can take up to 12 months.