Kenya is currently working towards achieving the World Health Organization’s (WHO) Maturity Level 3 (ML3) accreditation, an important milestone in enhancing the nation’s pharmaceutical regulatory framework. This recognition would place Kenya alongside other African nations such as Rwanda, Senegal, Tanzania, Nigeria, Ghana, Zimbabwe, Egypt, and South Africa, which have already attained this accreditation. Achieving ML3 signifies a well-functioning, reliable, and effective regulatory system for medicines and medical products.
What Are WHO Maturity Levels?
The WHO uses the Global Benchmarking Tool (GBT) to assess the capacity and performance of National Regulatory Authorities (NRAs) in ensuring the quality, safety, and efficacy of medical products.
Based on over 250 indicators, NRAs are classified into four maturity levels:
1. Maturity Level 1 (ML1)
Maturity Level 1 (ML1) represents the most basic stage of regulatory development, where a country either lacks a formal medicines regulatory authority (MRA) or has one that is severely underdeveloped and ineffective.
At this stage, mechanisms for ensuring the safety, efficacy, and quality of medicines are either non-existent, fragmented, or poorly enforced.
Here are some of the key characteristics of ML1 regulatory systems:
Lack of a Dedicated Medicines Regulatory Authority (MRA)
Many ML1 countries do not have a central agency responsible for medicine regulation. Instead, multiple government bodies may handle different aspects of regulation, leading to inconsistencies and gaps in oversight.
In some cases, the ministry of health may oversee drug approval and distribution, but without clear laws or guidelines, leading to an uncoordinated approach.
No Formal Product Registration System
There are no established processes for evaluating and approving medicines before they reach the market.
Manufacturers and distributors may introduce pharmaceutical products without undergoing safety, efficacy, or quality assessments.
Substandard and falsified medicines proliferate due to the lack of regulatory scrutiny.
Weak or Absent Pharmacovigilance System
ML1 countries often lack mechanisms for monitoring adverse drug reactions (ADRs) and drug safety.
Without surveillance systems, unsafe or ineffective medicines can circulate widely, endangering public health.
Unregulated Distribution and Sales of Medicines
Medicines may be sold without prescriptions, increasing the risk of misuse, antibiotic resistance, and adverse effects.
Informal markets, including street vendors and unlicensed pharmacies, dominate the pharmaceutical supply chain.
Counterfeit and substandard drugs are common, posing serious health risks to consumers.
Lack of Trained Regulatory Personnel
There is often a shortage of qualified professionals, such as pharmacists, regulatory scientists, and inspectors, to enforce regulations effectively.
Without adequately trained staff, even if regulatory policies exist, they remain unenforced due to capacity limitations.
Limited or No Post-Market Surveillance
Once medicines enter the market, there is no structured system to monitor their performance or quality.
Substandard products may remain on the market for years without detection.
Are there consequences of being at Maturity Level 1? Yes. Here are some of them:
Increased Prevalence of Substandard and Falsified Medicines
A weak regulatory system creates an environment where counterfeit drug manufacturers can thrive.
Patients may consume medicines with incorrect dosages, harmful contaminants, or no active ingredients at all.
Public Health Risks and Poor Treatment Outcomes
Patients may develop resistance to essential antibiotics and other critical medicines due to the widespread availability of fake or poor-quality drugs.
Life-threatening conditions such as malaria, tuberculosis, and HIV/AIDS may go untreated due to ineffective medications.
Loss of Investor and International Trust
International pharmaceutical companies are unlikely to invest in a country with an ML1 regulatory environment due to the lack of legal protections and market unpredictability.
Global health organizations, such as the WHO and donor agencies, may hesitate to fund medical initiatives if they cannot guarantee medicine quality and safety.
Challenges in Disease Control
ML1 countries struggle to contain disease outbreaks due to a lack of control over medicines and vaccines.
During health emergencies, they rely heavily on foreign aid and donations, often receiving surplus or outdated stock.
Examples of ML1 Situations in the Past
Liberia and Sierra Leone (Pre-Ebola Era)
Before the 2014 Ebola outbreak, Liberia and Sierra Leone had minimal regulatory oversight for pharmaceuticals, allowing unregulated medicine imports and sales. The lack of a structured regulatory framework contributed to difficulties in ensuring the availability of high-quality medicines during the health crisis.
Somalia
The ongoing political instability in Somalia has severely hampered regulatory capacity, resulting in widespread counterfeit drug markets. Many pharmacies operate without proper licenses, and there is little enforcement of medicine quality standards.
South Sudan (Emerging from ML1)
South Sudan has been working toward establishing a formal medicines regulatory authority, but its current system remains largely informal, with heavy reliance on non-governmental organizations (NGOs) and international aid for medicine supply.
Pathway Out of ML1
Countries at ML1 must take significant steps to establish a functional regulatory framework:
Establish a Dedicated Medicines Regulatory Authority
Setting up an independent, well-resourced body to oversee drug approvals, inspections, and quality control.
Develop and Enforce Regulatory Laws
Implementing legal frameworks that mandate medicine registration, licensing of pharmacies, and enforcement of quality standards.
Capacity Building for Regulatory Staff
Training professionals in drug evaluation, market surveillance, and enforcement to strengthen regulatory functions.
Implementing Basic Pharmacovigilance Systems
Establishing reporting mechanisms for adverse drug reactions and medicine safety monitoring.
Collaboration with Regional and International Bodies
Seeking technical assistance from WHO, African Medicines Agency (AMA), and other regulatory bodies to improve systems and transition to ML2.
2. Maturity Level 2 (ML2)
Maturity Level 2 (ML2) represents a transitional phase in regulatory development, where a country has established some foundational regulatory structures but has yet to achieve full functionality and effectiveness. At this level, a national medicines regulatory authority (MRA) typically exists, but it still faces challenges in enforcing regulations, ensuring compliance, and operating at an optimal capacity.
This stage is often characterized by progress toward structured oversight, but significant gaps remain, particularly in resources, technical expertise, and system automation. While ML2 countries have made efforts to regulate pharmaceuticals, they may still struggle with inconsistencies in enforcement, reliance on external technical support, and inadequate post-market surveillance.
Here are some of the characteristics of ML2 regulatory systems:
Presence of a Regulatory Authority, But With Limitations
Countries at ML2 have typically established a medicines regulatory agency or a similar governing body.
The agency may have legal backing but lacks full autonomy or sufficient funding to operate effectively.
The regulatory body may not have complete oversight over all pharmaceutical activities, leading to regulatory loopholes.
Defined Medicine Registration and Licensing, But With Gaps
A formal process for drug registration exists, requiring pharmaceutical companies to submit evidence of safety, efficacy, and quality.
However, approval processes may be slow, with long turnaround times due to limited personnel and expertise.
Not all medicines on the market may be registered, leading to unregulated products in circulation.
Inconsistent Enforcement of Good Manufacturing Practices (GMP)
There are guidelines for manufacturing standards, but enforcement is not always rigorous.
Local pharmaceutical manufacturers may not fully comply with internationally recognized GMP requirements.
Regulatory inspections of manufacturing facilities occur, but they may not be frequent or comprehensive enough to detect all quality issues.
Limited Post-Market Surveillance and Pharmacovigilance
ML2 countries have some form of pharmacovigilance system in place, often supported by WHO or donor agencies.
Reports on adverse drug reactions (ADRs) are collected but may not be systematically analyzed or acted upon.
Counterfeit and substandard medicines remain a challenge, as regulatory authorities lack the capacity to conduct frequent market surveillance.
Developing but Fragmented Distribution and Supply Chain Regulations
Regulations for drug distribution exist, but compliance remains uneven.
Some medicines are still accessible through unregulated markets or informal vendors.
Drug importation processes are partially controlled, but there may still be cases of unauthorized imports.
Shortage of Skilled Regulatory Personnel
The regulatory workforce often lacks sufficient training and expertise in key areas such as clinical trial evaluation, GMP inspections, and pharmacovigilance.
Authorities may rely on external consultants, WHO experts, or partnerships with foreign agencies to conduct specialized assessments.
Partial Use of Digital and Automated Regulatory Systems
Some ML2 countries have begun implementing digital platforms for drug registration and tracking, but full automation is not yet in place.
Regulatory systems may still involve manual or paper-based processes, leading to inefficiencies and delays.
Examples of ML2 Regulatory Systems
Uganda’s National Drug Authority (NDA) – Transitioning to ML3
Uganda’s NDA has made significant progress in strengthening its regulatory framework. It has established structured medicine registration processes, improved pharmacovigilance reporting, and adopted electronic systems for tracking drug approvals. However, challenges remain in enforcement, particularly in controlling the circulation of counterfeit medicines.
Zambia’s Medicines Regulatory Authority – Strengthening Post-Market Surveillance
Zambia has a functional regulatory authority that has developed medicine approval systems and licensing protocols for pharmacies. However, its pharmacovigilance system is still evolving, and there is a need for stronger enforcement of GMP standards.
Ghana’s FDA – Strengthening GMP Compliance
Ghana’s Food and Drugs Authority (FDA) is considered one of the more advanced ML2 regulators. It has introduced strict regulatory requirements for pharmaceutical manufacturers but still faces challenges in post-market monitoring and ensuring compliance among smaller pharmaceutical companies.
Steps Required to Advance from ML2 to ML3
For an ML2 country to progress to Maturity Level 3 (ML3), it must:
Strengthen Legal and Institutional Frameworks
Ensure that the medicines regulatory authority has full autonomy, legal backing, and adequate funding.
Establish clearer regulations for all aspects of pharmaceutical regulation, including clinical trials, manufacturing, and distribution.
Enhance Inspection and Quality Assurance Capabilities
Train more regulatory personnel to conduct GMP inspections, market surveillance, and pharmacovigilance activities.
Implement risk-based inspections to prioritize high-risk medicines and manufacturers.
Improve Pharmacovigilance and Post-Market Surveillance
Develop a robust system for tracking and responding to adverse drug reactions.
Implement real-time reporting mechanisms and encourage healthcare professionals to report safety concerns.
Expand Digital and Automated Regulatory Processes
Shift from manual to fully digital regulatory systems for medicine registration, importation approvals, and compliance tracking.
Adopt data-driven regulatory decision-making to improve efficiency.
Strengthen Collaboration with International Agencies
Work with the WHO, African Medicines Agency (AMA), and regional regulatory bodies to harmonize standards and adopt best practices.
Engage in regulatory reliance and mutual recognition agreements to improve efficiency.
3. Maturity Level 3 (ML3)
Maturity Level 3 (ML3) represents a significant milestone in the development of a country’s regulatory authority. At this level, the regulatory system is well-established, functional, and capable of ensuring that medicines and other medical products meet high standards of quality, safety, and efficacy.
Unlike lower maturity levels, where regulatory processes may be inconsistent or fragmented, ML3 countries have strong legal frameworks, efficient regulatory processes, and robust enforcement mechanisms. Regulatory agencies at this level operate with a high degree of professionalism, leveraging modern technology, skilled personnel, and internationally recognized best practices to oversee the pharmaceutical sector effectively.
Here are key characteristics of ML3 regulatory systems:
Strong Legal and Institutional Framework
The regulatory authority is fully established, legally recognized, and operates independently with minimal political interference.
Regulations cover the entire pharmaceutical lifecycle, including drug development, manufacturing, importation, distribution, marketing, and post-market surveillance.
Regulatory policies align with international standards set by organizations such as the World Health Organization (WHO), the International Council for Harmonization (ICH), and the African Medicines Agency (AMA).
Efficient and Transparent Drug Registration Processes
A structured and transparent marketing authorization process ensures that only safe, effective, and high-quality medicines enter the market.
Well-defined timelines exist for evaluating and approving new medicines, reducing unnecessary delays in access to essential treatments.
The regulatory authority employs risk-based assessments, prioritizing critical medicines and innovative therapies while maintaining rigorous evaluation standards.
Stringent Good Manufacturing Practices (GMP) Enforcement
Manufacturing facilities—both local and international—are subjected to regular inspections to ensure compliance with GMP standards.
Inspections are conducted using risk-based approaches, focusing on high-risk products and facilities with past compliance issues.
Regulatory authorities have mechanisms for recalling substandard or falsified medicines, preventing their circulation in the market.
Advanced Pharmacovigilance and Post-Market Surveillance
A well-functioning pharmacovigilance system actively monitors adverse drug reactions (ADRs) and safety signals.
Regulatory agencies work closely with healthcare professionals, patients, and pharmaceutical companies to gather and analyze safety data.
Authorities can issue drug safety alerts, revise product labels, or withdraw unsafe medicines when necessary.
Surveillance mechanisms are in place to detect and prevent counterfeit and substandard medicines.
Well-Regulated Importation and Distribution
The supply chain is strictly monitored to prevent the entry of counterfeit medicines and unauthorized products.
Only licensed importers and distributors are allowed to handle pharmaceuticals, reducing the risk of illegal trade.
The system includes track-and-trace mechanisms to ensure the integrity of the supply chain.
Adoption of Digital and Automated Regulatory Systems
Regulatory agencies use digital platforms for drug registration, licensing, and compliance monitoring, enhancing efficiency.
Artificial intelligence (AI) and data analytics are leveraged to support decision-making in regulatory processes.
A centralized regulatory database ensures information transparency and minimizes paperwork delays.
Recognition by International Regulatory Bodies
ML3 regulatory agencies meet WHO’s Global Benchmarking Tool (GBT) criteria, demonstrating their competence.
Many ML3 authorities become members of global regulatory networks, facilitating regulatory reliance and mutual recognition agreements.
Approval decisions from ML3 countries are often accepted by other nations, reducing duplication in drug registration.
Examples of ML3 Regulatory Agencies
Rwanda Food and Drugs Authority (Rwanda FDA)
Rwanda was recently awarded ML3 status by the WHO, marking a major achievement in its regulatory capacity. Rwanda FDA has demonstrated strong enforcement of drug safety, GMP compliance, and post-market surveillance. The agency’s digitalized systems and robust pharmacovigilance framework contributed to its ML3 accreditation.
Tanzania Medicines and Medical Devices Authority (TMDA)
TMDA has significantly improved its regulatory functions, ensuring that medicines entering the Tanzanian market meet international standards. The agency has adopted electronic regulatory systems, improving efficiency in drug approvals and safety monitoring.
Ethiopian Food and Drug Authority (EFDA)
Ethiopia’s regulatory agency has advanced its pharmaceutical quality assurance processes, leading to its recognition at ML3. EFDA has strengthened its post-market surveillance and regulatory enforcement mechanisms.
How ML3 Accreditation Impacts Pharmacy Practice
Improved Access to Quality Medicines
With stronger quality control systems, pharmacists can trust that the medicines they dispense meet international safety and efficacy standards.
The availability of substandard and counterfeit medicines is significantly reduced.
Greater Professional Accountability
Pharmacists are required to adhere to stricter regulatory guidelines when handling, prescribing, and dispensing medicines.
Regulatory oversight ensures ethical pharmacy practice, reducing malpractice and unethical promotions of medicines.
Increased Participation in Clinical Research
An ML3-rated regulatory system attracts clinical trials and research collaborations, providing opportunities for pharmacists to engage in cutting-edge pharmaceutical developments.
Local pharmacists and researchers can contribute to new drug development and regulatory decision-making.
Better Pharmacovigilance Engagement
Pharmacists play a central role in detecting and reporting adverse drug reactions (ADRs) to strengthen medication safety.
Regulatory agencies work closely with pharmacy professionals to enhance drug safety monitoring.
Faster Approval of Essential and Innovative Medicines
A well-functioning regulatory authority ensures that new and innovative treatments reach patients more quickly.
Pharmacists can offer patients better treatment options, particularly for life-threatening conditions.
Economic Significance of ML3 Accreditation
Boosting Local Pharmaceutical Manufacturing
ML3 accreditation encourages investment in local pharmaceutical production, reducing reliance on imports.
Pharmaceutical companies gain confidence in the regulatory system, leading to increased production and innovation.
Enhancing Trade and Export Opportunities
An ML3-certified country can export locally manufactured medicines to other regions that recognize its regulatory standards.
This improves economic growth and strengthens the country’s position in the African pharmaceutical market.
Attracting Foreign Investment in Healthcare
International pharmaceutical companies are more likely to establish manufacturing plants and research facilities in ML3 countries.
This leads to job creation, technology transfer, and economic expansion.
Lower Healthcare Costs
With a better-regulated pharmaceutical market, patients benefit from safer, more affordable medicines.
Public health expenditure is optimized as substandard and ineffective medicines are eliminated.
Steps for Kenya to Achieve ML3 Accreditation
Kenya’s Pharmacy and Poisons Board (PPB) is actively working toward achieving ML3 accreditation. To reach this goal, the country must:
Enhance Pharmacovigilance and Market Surveillance
Strengthen adverse drug reaction (ADR) reporting systems.
Increase routine inspections and post-market quality assessments.
Improve Regulatory Workforce Capacity
Invest in training programs for regulatory personnel, pharmacists, and industry stakeholders.
Enhance digital regulatory tools for efficiency.
Strengthen GMP Compliance and Inspections
Conduct more frequent and risk-based inspections of pharmaceutical manufacturers.
Ensure local production facilities meet international GMP standards.
Accelerate Digital Transformation
Fully transition to electronic drug registration, licensing, and tracking.
Implement AI-driven data analytics for decision-making.
Increase Public Awareness and Stakeholder Engagement
Educate pharmacists, healthcare workers, and the public about regulatory compliance and drug safety.
Encourage pharmaceutical companies to adopt global best practices.
Achieving Maturity Level 3 (ML3) accreditation is a game-changer for any country’s pharmaceutical industry. It signifies a trustworthy, efficient, and internationally recognized regulatory system that ensures the availability of high-quality, safe, and effective medicines. For Kenya, obtaining ML3 status would not only enhance public health outcomes but also create economic opportunities, attract investments, and position the country as a leader in the regional pharmaceutical market.
A stronger regulatory system benefits everyone—from patients to healthcare providers to the entire economy.
4. Maturity Level 4 (ML4)
Maturity Level 4 (ML4) represents the highest level of regulatory maturity recognized by the World Health Organization (WHO) through its Global Benchmarking Tool (GBT). At this level, a country’s regulatory authority is not just well-functioning but also highly advanced, operating at an internationally recognized level of excellence. An ML4-rated regulatory agency can efficiently regulate medicines, vaccines, and other medical products in a way that aligns with global best practices.
For countries striving for ML3 accreditation, achieving ML4 is the next major milestone. It signifies that the regulatory authority is not only capable of ensuring the safety, efficacy, and quality of medicines domestically but is also influential in global regulatory decision-making.
Here are characteristics of an ML4 regulatory system:
Regulatory System is Globally Recognized
The agency is internationally respected and can serve as a reference authority for other regulatory agencies worldwide.
It participates in global regulatory networks such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Regulatory decisions made in ML4 countries are often accepted by other nations, reducing duplication in drug registration.
Strong Legal and Policy Frameworks
The regulatory agency operates independently and transparently, free from political interference.
Regulatory policies are continuously updated to align with scientific advancements, emerging health threats, and international regulatory standards.
It has a robust intellectual property protection system that supports pharmaceutical innovation and research.
Highly Efficient Drug Approval and Market Authorization Processes
New medicines, including biologics and innovative therapies, undergo rigorous yet efficient evaluation processes.
The agency has well-defined risk-based approaches that prioritize urgent medical needs without compromising safety.
Conditional approvals and fast-track pathways exist for essential and breakthrough medicines, ensuring timely access to life-saving treatments.
Advanced Pharmacovigilance and Market Surveillance
The agency runs a fully digital pharmacovigilance system, integrating real-time data analytics, artificial intelligence (AI), and big data tools to monitor drug safety.
It collaborates with global regulatory bodies such as the U.S. FDA, EMA (European Medicines Agency), and WHO, ensuring rapid response to adverse drug reactions (ADRs), recalls, and emerging safety concerns.
Counterfeit and substandard medicines are effectively tracked and eliminated from the market through blockchain technology and track-and-trace systems.
Stringent Good Manufacturing Practices (GMP) Compliance
All local and international pharmaceutical manufacturers supplying the market adhere to WHO GMP, PIC/S standards, and ICH guidelines.
The regulatory agency conducts regular, unannounced inspections of manufacturing facilities.
It has comprehensive quality control laboratories that conduct post-market testing to verify product quality.
World-Class Clinical Trial Oversight
The country is a preferred destination for clinical trials due to its well-defined research ethics guidelines, regulatory efficiency, and strong participant protection mechanisms.
The agency approves and monitors clinical research, ensuring adherence to Good Clinical Practice (GCP) standards.
It has harmonized regulatory pathways for new drug development, enabling faster and safer innovation.
Digital Transformation and Automation
The regulatory system is fully digital, reducing paperwork delays and human error.
It employs AI-driven regulatory analytics, blockchain for supply chain transparency, and cloud-based systems for global regulatory collaboration.
The agency can remotely conduct facility inspections and dossier assessments, speeding up decision-making.
Global Examples of ML4 Regulatory Authorities
U.S. Food and Drug Administration (FDA) – United States
The FDA is a gold standard regulatory agency known for its efficient drug approval process, strong enforcement of GMP compliance, and advanced pharmacovigilance systems.
Its decisions influence regulatory policies worldwide, and many countries adopt FDA-approved medicines without additional evaluation.
European Medicines Agency (EMA) – European Union
The EMA coordinates drug approvals across 27 EU member states, ensuring that all medicines meet uniform safety, efficacy, and quality standards.
It has fast-track approval pathways for breakthrough drugs and a centralized pharmacovigilance database shared among EU nations.
Health Canada – Canada
Health Canada has an efficient market authorization system, ensuring timely access to safe and effective medicines.
It actively participates in global regulatory collaborations and mutual recognition agreements.
Therapeutic Goods Administration (TGA) – Australia
TGA ensures that biopharmaceuticals, vaccines, and medical devices meet the highest safety and efficacy standards.
It has stringent post-market surveillance systems and plays a significant role in the Asia-Pacific regulatory network.
Why ML4 Matters for Kenya and Africa
Strengthening Local Pharmaceutical Manufacturing
An ML4-rated regulatory system encourages local pharmaceutical companies to expand production capacity and manufacture higher-quality medicines.
It enables African pharmaceutical manufacturers to export their products internationally, boosting the continent’s self-sufficiency in medicine production.
Attracting International Pharmaceutical Investments
With an ML4 system, Kenya and other African countries could attract foreign pharmaceutical companies to establish research and manufacturing facilities.
This translates into more jobs, technology transfer, and economic growth.
Improving Access to Innovative Medicines
Countries with ML4 status gain priority access to new and breakthrough medicines.
Patients receive life-saving treatments faster, reducing the burden of non-communicable diseases (NCDs) like cancer, diabetes, and cardiovascular diseases.
Enhancing Africa’s Role in Global Health Security
An ML4 regulatory system allows Kenya and Africa to play a bigger role in global pandemic preparedness, vaccine development, and emergency response.
It ensures that vaccines and essential medicines are produced, distributed, and monitored effectively during health crises.
Maturity Level 4 (ML4) represents the pinnacle of regulatory excellence, enabling global recognition, stronger local pharmaceutical industries, and improved patient access to high-quality medicines. If Kenya is to transition to ML3 then ML4, it will require advanced digitalization, stronger enforcement of GMP, and faster regulatory decision-making.
Achieving ML4 would place Kenya at the forefront of Africa’s pharmaceutical leadership, enabling local manufacturers to compete globally, attract foreign investment, and enhance public health outcomes. The pharmacy community must support this journey by ensuring compliance, participating in regulatory decision-making, and advocating for a stronger, globally aligned regulatory system.
