Why Local Pharmacovigilance Matters: The Critical Role of the LQPPV in Kenya

Ensuring Patient Safety While Supporting Market Success

As pharmaceutical and biotechnology companies expand into emerging markets, regulatory expectations continue to evolve alongside growing healthcare demands. In Kenya, pharmacovigilance is becoming an increasingly important pillar in ensuring medicines remain safe, effective, and compliant throughout their lifecycle.

One key regulatory and operational requirement supporting this is the appointment of a Local Qualified Person for Pharmacovigilance (LQPPV). This role is essential in helping Marketing Authorization Holders (MAHs) maintain regulatory compliance while safeguarding patient safety.

What is an LQPPV and Why Does It Matter?

An LQPPV is a locally based pharmacovigilance expert responsible for overseeing medicine safety monitoring and ensuring compliance with local regulatory requirements. In Kenya, the LQPPV serves as the primary pharmacovigilance contact with the Pharmacy and Poisons Board (PPB) and ensures that safety reporting obligations are fulfilled.

For companies entering or operating in Kenya, the LQPPV is not just a regulatory requirement, it is a strategic partner in maintaining compliance, managing safety risks, and supporting successful product lifecycle management.

Kenya’s Pharmacovigilance Landscape

Kenya continues to strengthen its regulatory oversight to align with global safety standards. The PPB requires Marketing Authorization Holders to establish and maintain effective pharmacovigilance systems to monitor product safety in real-world use.

According to PPB pharmacovigilance guidelines:

• MAHs must appoint a qualified and locally resident LQPPV.
• The LQPPV must act as the primary pharmacovigilance contact person for PPB.
• Companies must maintain an operational pharmacovigilance system.
• Adverse drug reactions must be reported within specified timelines.
• Pharmacovigilance documentation and training records must be maintained and inspection ready.

These requirements highlight the importance of strong local pharmacovigilance oversight.

The Value an LQPPV Brings to Pharmaceutical Companies

Protecting Patient Safety

The LQPPV ensures continuous monitoring of medicine safety through proper collection, evaluation, and reporting of adverse events. Early identification of safety signals helps prevent patient harm and supports responsible medicine use.

Supporting Regulatory Compliance

Local regulatory requirements can be complex and continuously evolving. Having an experienced LQPPV ensures companies remain compliant with local regulations and inspection requirements, minimizing compliance risks and potential delays.

Acting as a Local Safety Liaison

The LQPPV bridges communication between regulators, healthcare providers and global pharmacovigilance teams, ensuring timely and accurate information exchange.

Supporting Business Continuity and Market Access

A compliant pharmacovigilance system supports product registration, renewal, and long-term sustainability within the Kenyan market.

How Oximio Supports LQPPV and Pharmacovigilance Compliance

At Oximio, we understand the operational and regulatory challenges pharmaceuticals face when establishing pharmacovigilance systems in new markets. Our LQPPV services are designed to provide seamless compliance support while allowing sponsors to focus on their core operations.

Oximio LQPPV Services Include:

• Acting as the designated Local Qualified Person for Pharmacovigilance
• Establishing and maintaining local pharmacovigilance systems
• Ensuring compliance with PPB pharmacovigilance guidelines
• Supporting adverse event reporting and safety monitoring
• Assisting with Risk Management Plan implementation
• Supporting regulatory inspections and pharmacovigilance audits
• Providing local pharmacovigilance training and procedural support
• Facilitating communication between global PV teams and local stakeholders
• By combining regulatory expertise, clinical trial logistics experience, and strong local regulatory engagement, Oximio provides integrated support that simplifies pharmacovigilance compliance.

Why Partnering with a Local PV Expert Matters

For many organizations, maintaining a fully operational local pharmacovigilance system can require significant resources, infrastructure, and regulatory expertise. Partnering with an experienced service provider such as Oximio offers several advantages:

• Reduced regulatory and operational risk
• Faster implementation of compliant pharmacovigilance systems
• Access to local regulatory expertise
• Enhanced inspection readiness
• Streamlined safety reporting processes

This partnership allows companies to maintain compliance while accelerating their market entry and operational efficiency.

Supporting the Future of Medicine Safety in Kenya

As Kenya continues to strengthen its healthcare and regulatory landscape, the importance of strong pharmacovigilance systems continues to grow. The LQPPV plays a central role in ensuring medicines remain safe and compliant, ultimately protecting patients and supporting healthcare system integrity.

Organizations that invest in strong pharmacovigilance oversight demonstrate their commitment to patient safety, regulatory compliance, and responsible healthcare delivery.

To find out how Oximio can support you with your supply chain solutions for clinical trials in Africa and beyond, visit our website or contact us for further information. We’d be delighted to discuss your requirements.

Author:
Beth Karimi,
Responsible Pharmacist.

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