By Priscilla Phiri

Lilongwe, November 12, Mana: In a breakthrough, Malawi’s Pharmacy and Medicines Regulatory Authority (PMRA) has joined the global elite in medicines and medical supplies testing, ensuring safer healthcare for millions.

With a hefty sum of K276 billion grant from the Global Fund, PMRA’s laboratory has earned an ISO 17025 accreditation, which puts PMRA on the global map as a trusted authority in medicine testing.

Through this accreditation, PMRA can now perform thorough and precise tests on medications, ensuring they meet the highest safety and efficacy standards.

Director General for PMRA, Mphatso Kawaye, the journey began with a critical self-assessment in 2015 when an audit revealed key challenges that PMRA had.

“This assessment identified four key issues which were insufficient laboratory space, inadequate equipment and unqualified staff as well as the absence of a proper quality management system,” he said.

Realizing the impact of the outcomes of the assessment in the operations of the authority, PMRA went further to address some of the challenges through construction of the state-of-the art laboratory and office space with funding from Malawi government and Global Fund.

Beyond just constructing the building, PMRA needed to resolve equipment and quality management deficiencies. To do this systematically, the authority proposed a Laboratory Capacity Building Project to the Global Fund which was approved under the NFM3 in 2018.

According to Kawaye, this project has been implemented until 2024 culminating PMRA’s accreditation.

With this grant, PMRA now has a high-end gear procured at a tune of USD 728,000 with funding from the Global Fund which has also covered maintenance service expenses for the equipment realizing that the advanced equipment requires specialized companies for servicing.

Among other equipment that PMRA procured are: High Performance Liquid Chromatography (HPLC), Microbial Testing Equipment, Fourier- Transform Inferred Spectroscopy (FTIR), and Gas Chromatography-Mass Spectrometry (GC-MS).

Additionally, the initiative included an extensive training for PMRA’s analysts, equipping them with the skills needed to operate the new equipment. 

The training was done by USP-Ghana, a renowned expert in pharmaceutical regulation and quality assurance in Africa.

This development marked a significant milestone for PMRA in positioning it as a key player in the global effort to ensure quality and safety of pharmaceuticals.

“As we speak, now PMRA’s National Quality Control Laboratory is ISO17025 accredited, and we can give reliable results.

“Just by getting this accreditation we are qualified to be testing medicines that are bought by UN organizations or even Global Fund itself whose quality assurance policies clearly states that you cannot test products bought through its systems in a lab that is not accredited or World Health Organization (WHO) qualified,” said Kawaye.

PMRA’s well known Chief Medical Analyst, Steven Chapima, highlighted the impact of the accreditation.

“Before the accreditation, when we test medicine and find that they are of poor quality, the suppliers would challenge our tests. This would leave us with no choice but to send the results to other reference labs for verification.

“This process took too much time and could not allow our clients like the Central Medical Stores Trust to distribute the medicines to hospitals and it could not allow them to dispose the medicines and in so doing patients were kept waiting for the medicines.

“Now that we are ISO 17025 certified, our results stand on their own which has reduced the time spent between testing of the medicine, distribution and patient use,” Chapima said.

He revealed that the new equipment has also built PMRA’s capacity to test most essential medicines like ARVs among others and perform critical checks of medicines before their registration and distribution.

Mixing Analyst, Moses Sondashi, who is among PMRA’s seven analysts that benefited from the USP Ghana mentorship, hailed the training saying it has helped him stay updated with pharmaceutical technicalities, ensuring quality aspects and good laboratory practices

In addition to its laboratory accreditation, PMRA has made significant strides in pharmacovigilance.

The authority said has established a robust system for monitoring and reporting adverse drug reactions, enhancing patient safety.

With PMRA’s upgraded capabilities, Malawians will benefit from enhanced medicine quality control, reduced risk of substandard medicines, improved patient safety, and increased confidence in the healthcare system.

Notably, the prevalence of substandard medicines in Malawi is currently estimated at 4 percent, below the global average.

According to WHO Regional Director for Africa, Dr Matshidiso Moeti, access to quality medicines is a fundamental right and there is need to ensure that all medicines meet the highest standards.

Global Fund’s investment in PMRA demonstrates the power of collaborative efforts. By supporting national institutions, the Global Fund contributes to strengthened health systems, improved access to quality medicines, and enhanced capacity for disease prevention and treatment.

This achievement showcases the Global Fund’s transformative impact on healthcare systems worldwide. By empowering institutions like PMRA, the Global Fund saves lives, improves health outcomes, and strengthens global health security.

As PMRA continues to grow and develop, its impact on Malawi’s healthcare system will be profound. Safer medications, improved patient safety, and enhanced health outcomes will be the hallmarks of PMRA’s success.

With this achievement, Malawians can trust that their medications are safe and effective. The country’s pharmaceutical landscape has been forever changed.

Global Fund is a financing institution that works in a partnership and achieves success by supporting implementer governments, affected communities and other stakeholders in the country to have the tools that they themselves determine are needed to fight HIV, tuberculosis and malaria.