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.
Public notice – Invitation to CPD policy and guidelines orientation meeting
The Pharmacy and Medicines Regulatory Authority (PMRA) invites all relevant stakeholders, including pharmacists, pharmacy technologists, pharmacy assistants, healthcare providers, employers and pharmacy training institutions to a Continuing Professional Development (CPD) Policy and Guidelines orientation meeting to be held on Saturday, 30th November, 2024 at Crossroads Hotel in Lilongwe.
Read more here.
PMRA joins global antimicrobial resistance awareness campaign
Today PMRA participated in a joint health talk at Kamuzu Central Hospital (KCH) in Lilongwe organised by the Antimicrobial Resistance (AMR) National Coordinating Committee to raise awareness about the growing threat of AMR.
The joint health talk, which targeted patients, guardians and hospital staff, was part of activities being carried out by the Ministry of Health as the country observes this year’s World Antimicrobial Resistance Awareness Week (WAAW).
In his remarks, PMRA’s National Pharmacovigilance Coordinator Anderson Ndalama said AMR was one the top global public health threats requiring concerted efforts by all stakeholders to combat.
He called on the citizens to desist from practices that drive AMR such as misuse of antibiotics.
Antimicrobials – including antibiotics, antivirals, antifungals, and antiparasitics – are medicines used to prevent and treat infectious diseases in humans, animals and plants.
Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi and parasites no longer respond to antimicrobial medicines. As a result of drug resistance, antibiotics and other antimicrobial medicines become ineffective and infections become difficult or impossible to treat, increasing the risk of disease spread, severe illness, disability and death.
The World AMR Awareness Week is a global campaign to raise awareness and understanding of AMR and promote best practices among One Health stakeholders to reduce the emergence and spread of drug-resistant infections.
WAAW is celebrated from 18-24 November every year. The theme for the World AMR Awareness Week (WAAW) 2024 is “Educate. Advocate. Act now.”
Global Fund Mission visits PMRA Lab
The Global Fund Mission to Malawi on Tuesday, 19th November, 2024 visited the Pharmacy and Medicines Regulatory Authority’s National Medicine Quality Control Laboratory (NMQCL) to appreciate the Authority’s enhanced capacity for quality assurance.
PMRA is proud to acknowledge Global Fund’s support in establishing a Quality Management System (QMS) according to ISO/IEC 17025:2017 Standard and equipping the Laboratory.
The Mission was in the country for the Fund’s 52nd Board Meeting.
Robust criminal justice response key to effective medicine regulatory enforcement
An effective medicine regulatory enforcement which is well complemented by a robust criminal justice response has potential to effectively prevent and deter pharmaceutical crimes, Pharmacy and Medicines Regulatory Authority (PMRA) Director General Mphatso Kawaye has said.
Kawaye made the remarks on Thursday in Mzuzu at the start of a two-day sensitization workshop for Northern Region-based magistrates on the legal framework of the medicine regulatory system in Malawi.
He reiterated that the country has a legislative framework to effectively prevent and respond to pharmaceutical criminal activities that are prevalent in the country including theft of medicines, illegal possession of medicines, trafficking of falsified and substandard medicines, and other related crimes.
“The public health impact of these activities cannot be underestimated. Medicines that are unapproved, stolen or illicitly trafficked are usually sourced from non-compliant manufacturers, and transported and stored without regard to regulatory requirements.
“This practice affects medicine quality and ultimately result in poor treatment outcomes for patients. Also the theft of medicines from health facilities deprives legitimately deserving patients the right to life and good health,” said Kawaye calling for stiffer penalties for convicted pharmaceutical crime offenders.
In her remarks, Guest of Honour and Chairperson of the Judiciary Training Committee, Justice Violet Chipao described the training as a significant step towards achieving collective understanding of the laws and regulations that govern the pharmaceutical sector in the country.
“As magistrates, your role is interpreting and enforcing this Act [PMRA Act, 2019] is crucial. Your decisions directly impact public health and safety, making it imperative that you are well versed in the provisions and implications of this legislation,” said Justice Chipao.
She echoed Kawaye’s sentiments saying if sentences are not deterrent enough, the law loses its value as individuals who weigh the potential of the costs of the crime against the benefits of the crime before deciding to engage in criminal activity find it beneficial to engage in the criminal activity.
She emphasized that penalties imposed by the Courts in pharmaceutical related crimes ought to reflect the seriousness of the offenses.
On his part, Association of Magistrates (AMA) President His Worship Kondani Chinangwa thanked PMRA for organsing the training workshop describing it as a good opportunity to provide insight into the work of magistrates in as far as handling of pharmaceutical crimes is concerned.
The training workshop is the second following a similar one held in Mponela, Dowa on 3rd and 4th October, 2024, targeting magistrates from Central Region.
PMRA takes part in global campaign for safer use of medicines
PMRA is among 106 national regulatory agencies and international non-governmental organisations, across 94 countries, taking part in this year’s #MedSafetyWeek, a global social media campaign aimed at raising awareness about the importance of reporting side effects of medicines.
#MedSafetyWeek is an international campaign led by Uppsala Monitoring Centre (UMC), the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. The campaign is supported by WHO and by members of the International Coalition of Medicines Regulatory Authorities (ICMRA).
Medicines are used by millions of people to treat their illness. However, sometimes medicines can cause side effects. By using medicines correctly, we can drastically reduce the risk of side effects and severe harm. And by reporting side effects when they occur, we can help make medicines safer for everyone.
This year’s ninth global #MedSafetyWeek campaign theme centres on the importance of using medicines in the right way to prevent side effects, and to report side effects when they do occur.
Research shows that about half of all side effects are preventable. Patient safety is our top priority and during the #MedSafetyWeek campaign, we want to remind patients to take their medicines as instructed and healthcare professionals to review therapies before prescribing them.
The purpose of safety monitoring is to gain more information about known side effects and find out about new ones. Constantly collecting and monitoring information from the reports received helps identify risks associated with medicines and take action to minimize harm.
Recent regulatory enforcement action against non-compliant premises and personnel
The Pharmacy and Medicines Regulatory Authority (PMRA) is informing the general public that, pursuant to Section 36 as read with Section 37 of the PMRA Act, 2019, the Authority, at its 81st Board Meeting, considered and decided over five disciplinary cases involving three retail pharmacies, one medicine store and one pharmacist as listed below.
The Authority commenced regulatory action against owners of the listed pharmaceutical establishments and personnel for contravening relevant laws and regulations under the PMRA Act, 2019 and the Pharmacy Code of Ethics, including operating premises without qualified pharmacy personnel, stocking prescription only medicines (POM), selling prescription only medicines without prescription, failure to maintain traceable records, and negligence.
All five cases registered a guilty verdict.
Read full statement here.
Malawi and India sign Memorandum of Understanding on pharmacopoeial cooperation
The governments of Malawi and India have signed a Memorandum of Understanding (MoU) on pharmacopoeial cooperation.
The signing of the MoU on Friday at Kamuzu Palace was part of bilateral talks between His Excellency President Dr. Lazarus McCarthy Chakwera and his Indian counterpart President Smt. Droupadi Murmu. The Indian President is in Malawi for a three-day state visit.
Among key areas under the agreement is to enhance cooperation in pharmacopoeia standards, specifically promoting understanding of Indian Pharmacopoeia (IP) in regulatory frameworks, requirements, and processes, considering that a significant proportion of medicines consumed in Malawi are manufactured in India.
This collaboration will facilitate the exchange of information and documentation related to the development of analytical methods published in IP.
PMRA Board Chairperson Mrs. Frider Chimimba and Indian High Commissioner to Malawi Mr. S. Gopalakrishnan signed the MoU, representing the Pharmacy and Medicines Regulatory Authority (PMRA) and the Indian Pharmacopoeia Commission (IPC), respectively.
President Chakwera and President Droupadi Murmu witnessed the signing of the agreement.
Commencement of baseline survey on 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.
PMRA engages judiciary on medicine regulatory legal framework
The Pharmacy and Medicines Regulatory Authority (PMRA) hosted a two-day interface meeting with a section of magistrates from Thursday to Friday at Chikho Hotel in Mponela, Dowa. The meeting aimed to reflect on the legal framework of the medicines regulatory system in Malawi and identify ways to enhance its effectiveness.
The Authority recognizes the judiciary as a vital partner in combating pharmaceutical crimes, including medicine theft, illegal possession of medicines, and the trafficking of falsified and substandard medicines.
By collaborating with the Judiciary, PMRA aims to ensure a more effective regulatory environment, discouraging non-compliance and promoting a healthier Malawi through assurance of quality, safe and efficacious medicines and allied substances.
PMRA is mandated by the PMRA Act, 2019 to ensure that medicines and allied substances that are used in the country are of acceptable quality, safe and efficacious.