Guidelines for registration of a new Drug in Kenya.

guidelines registration new drug Kenya

Guidelines registration new drug Kenya

The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. In some countries, such as Kenya, they are regulated at the national level by a single agency Pharmacy and Poisons Board.
The role of therapeutic goods regulation is designed mainly to protect the health and safety of the population. Regulation is aimed at ensuring the safety, quality, and efficacy of the therapeutic goods which are covered under the scope of the regulation. In Kenya, Drugs,supplements and medical devices must be registered before they are allowed to be marketed. There is usually some degree of restriction of the availability of certain therapeutic goods depending on their risk to consumers.
Drugs are usually categorized as:

  • Over the counter drugs: Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a prescription from a healthcare professional. In Kenya, OTC drugs are selected by Pharmacy and poisons board to ensure that their ingredients  are safe and effective when used without a physician’s care. OTC drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
  • Prescription drug:A prescription drug (also prescription medication or prescription medicine) is a pharmaceutical drug that legally requires a medical prescription to be dispensed. In contrast, over-the-counter drugs can be obtained without a prescription.

Below are some of the procedures:
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 –

ii. 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.

iv. A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.

v. Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not yet inspected by PPB.

Applications for Renewal of Registration Applications for renewal of registration shall be made at least 3 months before the expiry of existing registration by submitting the following:
i. Dully filled in application form for renewal of registration.

ii. Batch Manufacturing Record (BMR) of a real batch manufactured within at most six months before the submission of the application.

iii. Submit Periodic Safety Update Reports (PSUR)

iv. Proof of interchangeability for generics as explained in Module 5.

v. Any other requirements that the Board may determine.

vi. Three (3) samples of the smallest commercial pack(s) from the same batch along with batch certificates of analysis.

vii. A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.

viii. Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not inspected and approved by PPB, GMP department.

Application for Variation of a registered medicinal product All applications for variation to a registered product shall be made according to requirements stipulated in the PPB Application Guideline for Variation of Registered Medicinal Products also available the PPB offices.

The application should be submitted to the following address:
The Registrar,
Pharmacy and Poisons Board
Lenana Road,
P. O. Box 27663-00506,

For more information click here PPB

Citations/ references

  • Kawasaki, Eriko, and John P. Patten. “Drug supply systems of missionary organizations: identifying factors affecting expansion and efficiency: case studies from Uganda and Kenya.” Geneva: World Health Organization (2002).
  • O’Carroll, Sorcha. “Importing Indian Generic Drugs Following TRIPS: Case Studies of Zambia and Kenya.” unpublished paper (2005).
  • Avafia, Tenu, Jonathan Berger, and Trudi Hartzenberg. “The ability of select sub-Saharan African countries to utilize TRIPS flexibilities and competition law to ensure a sustainable supply of essential medicines: A study of producing and importing countries.” ICTSD, UNCTAD, TRALAC (2006).
  • Pharmacy, Kenya, and Poisons Board. “Registered Drugs.” Online) http://www. pharmacyboardkenya. org/index. php: 1-2.
  • “Information and guidance on prescribing in general practice” (PDF). British Medical Association.
  • Narcotic Drugs and Psychotropic Substances(Control) Act, 1994.

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