Guidance Notes for Establishing Medical Products and Health Technologies Manufacturing Facilities in Kenya

With increased applications for setting up manufacturing facilities in Kenya, and given the responsibility to regulate the manufacture and trade of Medical Products and Health technologies (MPHT), the Pharmacy and Poisons Board has developed this guidance for investors in Kenya. This guidance is intended to facilitate the setting up of pharmaceutical manufacturing facilities in Kenya fit for manufacture of good quality health products and technologies, that meet international standards as well as that protect personnel working in the premises.

These notes are intended to guide pharmaceutical regulation, establishment of manufacturing facilities for pharmaceutical and medical products as well as ease of doing business. For this purpose, the Pharmacy and Poisons Board has developed this first edition ‘Guidance Notes For Establishing Pharmaceutical Products Manufacturing Facilities in Kenya’

While this guidance will by no means eliminate any existing red tapes outside the purview of the Pharmacy and Poisons Board’s mandate, it is hoped that the notes will augment efforts by other relevant government agencies in establishment of manufacturing facilities. In dealing with only bureaucracies related to pharmaceutical inspections and approvals, this guidance notes in a great way contribute towards achievement of vision 2030 and Sustainable Development Goal (SDG) 3, Sustainable Development Goal 9.

Over the years, pharmaceutical manufacturing including clean room technology has evolved so much that it is important for Pharmacy and Poison Board to establish a guidance document to ensure that the development and maintenance of new and existing clean room facilities are done according to current international standards.

Taking note that pharmaceutical manufacturing premises often require substantial resources to construct and maintain, standardization in the construction of Pharmaceutical Manufacturing is important for improving public health in Kenya and in the region. This guidance therefore, act as reference to ensure appropriate planning, development and upgrading of the pharmaceutical manufacturing facilities in Kenya.