PMRA launches state-of-the-art laboratory, celebrates ISO/IEC 17025:2017 accreditation
The Pharmacy and Medicines Regulatory Authority (PMRA) on Wednesday, 4th December, 2024, launched its state-of-the-art National Medicines Quality Control Laboratory (NMQCL) and celebrated the facility’s ISO/IEC 17025:2017 accreditation at a colurful ceremony presided over by Minister of Health, Khumbize Kandodo Chiponda.
The double celebration started with a solidarity walk from Chilambula High Way to PMRA Head Offices in Area 5 for the official launch and thereafter proceeded to Crossroads Hotel for the official presentation of the ISO/IEC 17025:2017 accreditation certificate to PMRA by the Chief Executive Officer of the Southern African Development Community Accreditation Service (SADCAS), Eve Christine Gadzikwa.
PMRA with funding from Malawi Government and Global Fund embarked on the construction of the Laboratory to address challenges related to Good Laboratory Practices, notably lack of space and absence of quality management system (QMS), in compliance with Section 79 of the PMRA Act, 2019.
Following completion of the construction works for the NMQCL, PMRA has made significant strides in strengthening its regulatory capacity, culminating in the ISO/IEC 17025:2017 accreditation of the Laboratory on 22nd February, 2024 by SADCAS.
The launch of the PMRA Laboratory marks a significant milestone in ensuring the quality, safety, and efficacy of medicines in Malawi. The Lab’s ISO/IEC 17025:2017 accreditation is a testament to PMRA’s commitment to international standards.
The ISO/IEC 17025:2017 accreditation of the National Medicines Quality Control Laboratory enhances credibility, ensures reliable results, and boosts client confidence. It also opens doors to international markets and opportunities to test medicines for regional countries and UN organizations; and ultimately reinforces Malawi’s capacity to assure quality of medicines.
The NMQCL is established under Section 79 of the PMRA Act, 2019 as one of the five departments of PMRA with the objective of verifying the safety, quality and efficacy of medicines and allied substances which are manufactured in or imported into the country by persons who are authorized or licensed under the Act.
Commencement of baseline survey on public awareness of PMRA mandate and functions
The Pharmacy and Medicines Regulatory Authority (PMRA) is notifying stakeholders, clients and the general public of commencement of a baseline survey on public awareness of the Authority’s mandate and functions.
The survey will be conducted from 20th October to 8th November, 2024, covering all 28 districts of Malawi.
The primary objective of this survey is to establish a public awareness index (PAI) for the Authority. The findings will inform strategic communication initiatives, enhance transparency, and foster accountability, ultimately enabling PMRA to better serve the public’s needs and interests.
Read more about the survey here.
Malawi has capacity to assure quality of medicines
The Pharmacy and Medicines Regulatory Authority (PMRA) has assured the public that Malawi has the necessary capacity to conduct rigorous medicine quality assessments for product registration and ongoing market surveillance, guaranteeing access to high-quality, safe, and effective medicines.
Among others, PMRA boasts of ISO/IEC 17025:2017 accredited laboratory attesting to Malawi’s capability and international recognition to test and assure the quality, safety and efficacy of medicines. ISO 17025 accreditation is a certification that recognizes a laboratory’s technical competence to carry out specific tests, calibrations, or measurements.
PMRA Director General Mphatso Kawaye made the remarks Tuesday in Lilongwe where the Authority addressed a media briefing to respond to findings of a study by Ethiopia’s Bahir Dar University on quality of medicines in Africa.
In particular, the Director General was commenting on an article published in the UK-based Guardian newspaper of 4th August, 2024, titled “Fifth of medicines in Africa may be sub-par or fake, research finds” which cited the Bahir Dar University study claiming that Malawi has one of the highest prevalence of substandard and falsified medicines in Africa.
“Using its Medicine Quality Control Laboratory which is ISO 17025 accredited, PMRA tests medicine samples prior to distribution and those samples collected through routine quality surveillance activities,” said Kawaye.
Among others, the Director General observed that the Bahir Dar University review referenced a 2015 Malawian study on anti-malarial medicines and used its findings to generalize the quality of all medicines in the country.
Said Kawaye: “The study which the article quoted only examined the quality of anti-malarial medicines which were: LA, Quinine, SP, DHA/SP, DHA/Pp, ATS/SmP, and ATS/SP. In addition, the study did not include samples from the government health facilities which constitute the largest proportion of anti-malarial medicines consumed in the country and whose brands are not found in the private sector.
“This means that the findings of this referenced 2015 study cannot be used to generalize the quality of all anti-malarial medicines let alone the quality of all medicines in the country.”
The DG further observed that the analytical method used for assessing LA in the 2015 reference study was modified from a published well validated method. However, the extent of the modification was quite significant and resulted into inferior validation parameters, rendering the method unsuitable for assessing quality of LA.
He cited an instance where samples from the same batch of LA gave significantly different results, which he said is not normal in medicines analysis especially considering that the samples were collected from regulated facilities.
“The failure rate of LA which had the highest number of samples in the 2015 study was largely due to analytical method problems. Had the analysis been as per the reference analytical method (Arun 2011), the failure rate could have been much different from the 88.4% that was reported in the 2015 Malawi study,” he said.
According to Kawaye, the Authority acknowledges the importance of studies conducted by institutions of higher learning whose recommendations inform both public health policy and medicines regulatory practice.
The Authority has since called for adherence to best research practices saying incorrectly done studies may raise alarm and grossly mislead the public to lose confidence in the public health sector. Further, such studies undermine the efforts by government institutions, partners and stakeholders in the health sector in ensuring access to quality health services.
PMRA hails Air Cargo Malawi’s pharma service launch
The Pharmacy and Medicines Regulatory Authority (PMRA) has commended Air Cargo Malawi Limited for launching a pharmaceutical service describing the development as a positive step towards improving healthcare outcomes for the country.
The new pharma service will see Air Cargo Malawi Limited in partnership with Emirates Airlines commence transportation of pharma products from Europe, the UAE, India and China to Malawi. Previously, Emirates did not allow Air Cargo Malawi to carry pharmaceutical products due to safety concerns as pharma products are considered high risk.
Speaking when he presided over the launch, PMRA Director General Mphatso Kawaye noted that the service launch is a significant milestone in ensuring the availability and quality of pharmaceutical products in the country.
“The launch of this service is a testament to the critical role that effective logistics plays in ensuring the availability and quality of pharmaceutical products, which subsequently assure key actors in the health sector that patients get the right treatment outcomes,” said Kawaye.
He described the pharmaceutical industry in Malawi as a very important partner in the implementation of the Health Sector Strategic Plan (HSSP III), Malawi 2063 and Sustainable Development Goals (SDGs), all of which place much emphasis on universal health coverage with quality, available, equitable and affordable health care, on one hand, and efficient drug supply chain management through monitoring of quality of medicines and medical supplies, on the other.
Kawaye observed that the medicines regulatory environment in the country places immerse responsibility on pharmaceutical wholesalers as authorized importers of medicines, to make sure that the right medicine transportation requirements are met.
Added Kawaye: “Although the regulatory environment has placed this responsibility in the hands of the pharmaceutical wholesalers as importers, the quality assurance of products in transit including cold chain products is unfortunately not within their sphere of control.”
He then expressed optimism that the coming of Air Cargo Malawi Pharma Service will fill the gap and provide sustainable support to the importer in complying with the law as it relates to storage and transportation of temperature controlled pharmaceutical products.
He called on players in the pharmaceutical sector to complement the Air Cargo pharma service by ensuring that appropriate regulatory procedures are adhered to, both before and after the shipment of consignments.
Said Kawaye: “Let us realize that our proactive participation on the regulatory side partnered with Air Cargo Pharma’s expertise on the pharmaceutical handling side will create a highly efficient transportation solution for our temperature sensitive pharmaceutical products and contribute towards timely access to quality medicines for Malawians.”