Guidelines on Reliance Mechanisms: Fast-Tracking Medicine Approvals in Kenya

n Kenya, regulatory efficiency matters. The Pharmacy and Poisons Board (PPB) has introduced a set of reliance mechanisms. These mechanisms allow the agency to leverage decisions from trusted regulators. In doing so, they speed up medicine approvals without compromising safety, efficacy or quality.

This article explains what reliance mechanisms are, how they work in Kenya, and what companies need to do to take advantage of them.

What Are Reliance Mechanisms?

A reliance mechanism is a regulatory tool where one national regulatory authority gives significant weight to the work performed by another trusted regulator when approving a medicine.

The World Health Organization defines this approach as beneficial in optimising resources and improving timelines.

In Kenya’s context, the PPB issued the “Guidelines on Reliance Mechanisms for Marketing Authorization of Health Products and Technologies in Kenya”. These guidelines create pathways for faster approvals by recognising work done by reference authorities, reducing duplication.

Why Kenya Needs Faster Medicine Approvals

Kenya faces increasing pressure to deliver essential medicines timely. Demand for new treatments, emerging diseases and technology‐driven innovations have grown. By adopting reliance pathways, the PPB aims to reduce regulatory bottlenecks and improve access.

Also, global regulatory convergence encourages Kenya to align with international best practice. A recent workshop in Nairobi highlighted the low adoption but significant potential of reliance approaches in Kenya.

The Legal and Regulatory Framework

The PPB derives its mandate from the Pharmacy and Poisons Act and supportive regulations such as the Medicines and Allied Substances Act (as amended).

Under these laws, the PPB may approve, suspend or revoke marketing authorisations. With the new reliance guideline, the PPB formalises the use of trusted regulators’ assessments to inform its decisions.

Key Reliance Pathways Introduced by PPB

1. Reference Regulator Pathway

This pathway accepts a marketing authorisation granted by a recognised stringent or well-established regulatory authority. The PPB then uses that approval as a basis to expedite review.

2. Work-sharing or Collaborative Review Pathway

Applicants submit data simultaneously to multiple jurisdictions. The PPB may coordinate with other regulators and leverage their findings to shorten timelines.

3. Verification or Abridged Review Pathway

For products already approved elsewhere, the PPB conducts a targeted review of specific modules (such as manufacturing or clinical summary) instead of full standard review.

4. Emergency/Expedited Reliance Pathway

In public health emergencies, the PPB may use reliance mechanisms to fast-track approvals of vital medicines or vaccines.

Benefits of Using Reliance Mechanisms

• Shorter approval timelines – Applicants spend less time waiting for decisions.

• Reduced duplication of effort – The PPB uses existing assessments from trusted regulators, reducing the burden on applicants.

• Resource optimisation – The regulator can focus its resources on high-risk products and post-market surveillance.

• Improved access – Patients gain faster access to new, safe, effective medicines.

• Global alignment – Kenya signals commitment to regulatory convergence and international standards.

 

Practical Steps for Applicants: Navigating the Reliance Pathways

1. Check eligibility – Verify whether the product is approved by a recognised reference regulator and meets the criteria in the guideline.

2. Prepare a robust dossier – Include a summary of the reference agency’s approval, quality/manufacturing data, clinical evidence and safety profile.

3. Engage with PPB early – Consider pre-submission meetings to clarify which reliance pathway applies and what supporting documents are needed.

4. Submit through the designated online portal – Use PPB’s submission channel and tag the application as “Reliance Pathway”.

5. Respond promptly to queries – Once submitted, engage quickly with regulators to avoid delays.

6. Plan for post-market obligations – Even with reliance pathways, maintain pharmacovigilance, manufacturing oversight and local registration obligations.

 

Challenges and Considerations

The reliance model brings advantages but also challenges:

• Data transparency – Companies must supply unredacted reports from reference regulators.

• Local relevance – The regulator still assesses local context, disease profile and manufacturing site suitability.

• Infrastructure/Capacity – PPB and applicants need strong systems to handle reliance workflows. As one workshop found, industry awareness and regulatory capacity remain gaps in Kenya.

• Legal clarity – The guideline is relatively recent and stakeholders must monitor updates as practice evolves.

 

How Clarity Pharma Consultancy Can Help

If you are an innovator, manufacturer or distributor looking to leverage Kenya’s reliance pathways, Clarity Pharma Consultancy offers expert support.

We guide clients through the eligibility assessment, dossier preparation, submission planning, regulator engagement and post-market compliance.

Contact us for a tailored consultation and ensure your products are fast-tracked under Kenya’s reliance framework.

Kenya’s adoption of reliance mechanisms marks an important step toward faster, efficient, and safe access to medicines. The PPB’s guideline sets out clear pathways that reduce duplication and speed review without lowering standards. If you plan to register your product in Kenya, understanding and leveraging these mechanisms becomes vital. Early engagement, precise documentation and strategic planning position you for success.

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