PMRA, CMST sign MoU
The Pharmacy and Medicines Regulatory Authority (PMRA) and the Central Medical Stores Trust (CMST) on Friday signed a Memorandum of Understanding (MoU) to guide the two organisations’ regulator-vendor relationship.
The signing ceremony took place at CMST Headquarters in Lilongwe.
PMRA Director General Mphatso Kawaye hailed the signing of the MoU with CMST as a game changer as it sets standards and expectations for both organisations in their respective roles of acquisition and quality testing of medicines and allied substances.
“This landmark partnership is a victory for all Malawians. By joining forces as PMRA and CMST, we are reaffirming our shared dedication to ensuring that only medicines and allied substances of the highest standards are approved, distributed, and made accessible in our hospitals. This collaboration strengthens our resolve to protect the health and well-being of the nation,” said Kawaye.
Oh his part, CMST Chief Executive Officer, Dr Chikaiko Chadzunda, said the MoU brings several strategic and operational benefits to Malawi’s healthcare system, and hence promotes transformation from reactive crisis management to strategic handling of the country’s public health sector pharmaceutical needs.
Said Chadzunda: “The MoU guarantees strengthened collaboration through improved coordination between procurement and regulatory processes; enhanced medicine availability through faster clearance and registration of essential medicines; and better-quality supplies through improved compliance from joint oversight on medicine quality and safety standards.”
PMRA, through its ISO-accredited National Medicine Quality Control Laboratory (NMQCL) is mandated to conduct quality control testing of all medicines and allied substances procured by CMST prior to distribution to public health facilities.
The MoU, among others, seeks to ensure that all guidelines and policies on medicines and allied substances quality performances and recall are well coordinated between the parties.
WHO donates risk-based post-market surveillance e-tool to PMRA
…As Authority participates in multi-country Epione survey on quality of essential antibiotics
The World Health Organisation (WHO) Country Office on Tuesday formally handed over a bespoke e-tool (Epione), a risk-based post-market surveillance (PMS) tool to enable the Authority to participate in the multi-country survey on quality of essential antibiotics and anti-malarial medicines using the bespoke e-tool (Epione) platform.
The tool is part of WHO’s technical and financial support package worthy USD24,400 (about MK43 million) for the Authority to design and conduct PMS for selected medicines and sites in the country based on risk types.
Accroding to WHO Country Office’s Communicable and Non-Communicable Diseases Cluster Lead, Dr. Michael Kayange, the tool is part of the holistic Prevent-Detect-Respond Strategy agreed to by WHO member states which identifies PMS as a core regulatory function that helps assess and reinfornce the integrity of medicines’ supply chains and that a proven efficient approach to it is the risk-based PMS.
“Epione allows the regulatory authority to design and conduct post-market surveillance of selected medicines and sites based on various risk types. It was also demonstrated to reduce the cost and burden to regulatory authorities, whilst providing robust data upon which to prioritise often limited resources,” said Dr. Kayange.
On his part, PMRA Director General, Mphatso Kawaye, hailed WHO for the donation describing it as key to the Authority’s participation in the multi-country e-tool enhanced, stratified random survey on substandard and falsified medicines.
Kawaye said findings of the study will give a clear picture of the magnitude of the problem of substandard and falsified medical products in the country thereby paving way for implementation of systems to manage the risk.
“The Epione survey is very essential in the implementation of WHO recommendation on optimisation of the management of substandard and falsified products as we first need to know the burden and enablers of the SF problem in Malawi before we put in place relevant systems to address the problem.
“So the donated items to be used in the survey will make a huge difference in the prevention and response against substandard and falsified medical prodcuts in the country,” he said.
The survey which is fully supported by the WHO Member State mechanism for Substandard and Falsified medical products in being implemented in four countries which include Malawi, Burkina Faso, Congo and Niger.
The donated items include smart phones, sample collection bags, laboratory reagents and standards; as well as logistical support for field sample collection.
PMRA is expected to collect samples from at least 83 outlets across the country.
In the picture, WHO’s Dr. Kayange (2nd from left) symbolically hands over the survey materials to PMRA Director General as PMRA’s Head of Laboratory Steven Chapima and Head of HR and Admin Irene Dzanjalimodzi look on.