Marketing Authorisation
The Pharmacy and Poisons Board is empowered under Section 3A of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya (“The Act”), to formulate guidelines for regulating the manufacture, distribution, sale and use of health products and technologies, grant or withdraw authorization for health products and technologies, and prescribe the standards appropriate for new health products and technologies. The Pharmacy and Poisons Board, under Section 3B of The Act, is responsible for ensuring the quality and efficacy of health products and technologies, licensing and registration of medicinal substances, approve dossiers for marketing authorization, and maintain a register of all authorized/registered health products and technologies. Additionally, the Board disseminates information on health products and technologies to health professionals and the public, collaborates with other institutions on regulation, and performs other related functions. The mandate of the Board is to protect and promote the health of the public by regulating the profession of pharmacy and ensuring access to quality, safe and efficacious Health products and technologies.
To support the Board’s mission to protect and promote public health, the Department of Product Evaluation and Registration (DPER), operating under the Pharmacy and Poisons Board, is responsible for the evaluation and registration of human medicines, vaccines, herbal and alternative products, medical devices (including in vitro diagnostics), and blood products.
The board is responsible for the regulation and marketing authorization of pharmaceutical products containing small-molecule active substances to ensure they meet established standards of quality, safety, and efficacy. The division has developed Guidelines that assist applicants in preparing, submitting and maintaining applications. These guidelines also ensure transparency, predictability, and consistency in the evaluation process.
The division of Allopathic/small molecules remains dedicated to ensuring timely, rigorous and science-based evaluations that uphold the integrity of Kenya as the Pharmaceutical sector
The Biologics and Vaccines Division is entrusted with the critical responsibility of regulating the marketing authorization of vaccines and biological products in Kenya. This division ensures that all vaccines and biological products available in the country meet stringent standards of safety, efficacy, and quality. To fulfill its mandate, the division evaluates applications for marketing authorization based on comprehensive scientific evidence, including manufacturing processes, quality controls, clinical data, and stability information.
The division remains committed to facilitating timely access to high-quality vaccines and biological products while upholding regulatory standards that protect public health.
The Blood and Blood Products Division is responsible for regulating licensure of blood, blood components, and granting of marketing Authorization for plasma-derived medicinal products and other human-derived products, such as Cells and Tissues, to ensure their safety, quality, efficacy, and availability.
The division carefully evaluates applications for licensure and authorization by reviewing scientific data, donor screening protocols,testing, processing,storage, and distribution, and further manufacturing practices for compliance with regulatory frameworks and provisions. Successful regulation of blood and blood products depends on coordinated efforts among blood establishments, healthcare providers, manufacturers, distributors, and other relevant regulatory authorities. This collaboration ensures that safe, effective, and high-quality blood products are accessible to patients in need.
The division is committed to maintaining rigorous regulatory standards while facilitating timely access to critical blood, blood components, and plasma-derived products that contribute to improved health outcomes.
The Pharmacy and Poisons Board regulates herbal and complementary products to ensure they are of good quality, safe, properly labeled, and free from adulteration.
To guide this process, the Board has developed dedicated guidelines for the application, evaluation, and registration of herbal medicines. Given their growing use alongside conventional medicines, these guidelines help protect the public from unsafe, unsubstantiated medicinal claims and misleading products, while also promoting responsible use and integration into the healthcare system. The success of this initiative depends on the active collaboration of all stakeholders in ensuring that herbal and alternative medicines remain a trusted part of healthcare in Kenya.
The division remains committed to upholding regulatory standards that protect the public, while also supporting the responsible use of herbal and complementary health products in the broader health ecosystem. The division remains committed to upholding regulatory standards that protect the public, while also supporting the responsible use of herbal and complementary health products in the broader health ecosystem.
Market authorization for Medical Devices and In-Vitro Diagnostics (MD&IVDs) is granted through assessment of technical files submitted to the Board through the Directorate of Health Products and Registration.
The regulation of MD&IVDs has seen an acceleration of processes through the automation of all its services. The submission of Medical devices and diagnostics, which follow the risk-based classification of Class A (lowest risk devices) to Class D (Highest risk devices), is anchored on the essential principle of safety and performance, as outlined by the International Medical Device Regulators Forum.
Reliance practices through the assessment of WHO-Prequalified In-Vitro Diagnostics have been implemented as a pathway for faster access to the Kenyan Market.
Additionally, using Reference regulatory authorities, Medical Devices are facilitated to achieve timely access to the market in reliance of these authorities.
To keep abreast with the rapidly evolving health technologies landscape, the assessment of Medical Device Software has been implemented to take advantage of the current changes in the regulatory environment. Additionally, the use of AI and Machine Learning Medical devices has been incorporated into the current regulation for medical devices, ensuring the public has access to cutting-edge technologies.
The Medical Devices Team participates in the following international forums, demonstrative PPB’s role in international, continental, and Regional collaborative engagements
-The African Medical Devices Forum (Current Chair)
Documents under AMDF
- https://www.nepad.org/publication/guidelines-requirements-labelling-of-medical-devices-including-vitro-diagnostic
- https://www.nepad.org/publication/african-medical-devices-forum-guidelines-authorization-of-vitro-diagnostic
- https://www.nepad.org/publication/african-medical-devices-forum-procedure-field-safety-corrective-actions-medical
- https://www.nepad.org/publication/guidelines-registration-of-manufacturers-and-other-parties-and-listing-of-medical
- https://www.nepad.org/publication/guidelines-registration-and-listing-of-medical-devices-and-vitro-diagnostic-ivd
-The International Medical Devices Forum (Affiliate Membership)
-Global harmonization Working Party (Participating Membership)
The Cosmetic Division is responsible for the regulation and marketing authorization of cosmetic products to ensure they are safe for human use, meet quality standards, and are truthfully and accurately labeled. Cosmetics, including skincare, haircare, personal hygiene, and beauty products, are widely used and directly affect consumer health and well-being.
To protect the public from harmful or misleading products, all special cosmetics must undergo regulatory scrutiny prior to being placed on the market. The division evaluates marketing authorization applications based on product composition, safety data, manufacturing practices, labeling, and claims.
The division is committed to promoting consumer safety and product transparency through effective regulatory oversight of cosmetic products in the market.
The Health Supplements Division is responsible for overseeing the marketing authorization of health supplements to ensure they are safe, of high quality, and appropriately labeled for consumer use. The division evaluates marketing authorization applications through the review of product composition, manufacturing practices, safety data, labeling information, and claims made by the applicant.
The division is committed to protecting public health by ensuring that only safe and properly regulated health supplement products are authorized for sale and use.
Contacts
General Inquiries | drug_reg@ppb.go.ke |
Renewals | drugsrenewals@ppb.go.ke |
Cosmetics | cosmetics@ppb.go.ke |
Supplements | foodsupplement@ppb.go.ke |
Herbal | herbal@ppb.go.ke |
Medical Devices | medicaldevices@ppb.go.ke |
Biological Products | biologics@ppb.go.ke |
Regulatory Decisions
Guidelines and Procedures