PMRA unveils new five-year strategic plan

PMRA has today launched its new five-year strategic plan at a colourful ceremony held at the Bingu International Convention Centre (BICC) in Lilongwe.

Chairperson of the Parliamentary Committee on Health Dr. Matthews Ngwale presided over the launch which was also attended by USAID Health Office Deputy Director Dr. Haldon Njikho, WHO Rep Dr. Neema Kimambo and key players in the pharmaceutical sector, among others.

Chairperson of PMRA Board of Directors, Mrs Frider Chimimba described the development of the 2023/24-2027/28 blue print as a milestone towards enhancing service delivery.

Said Chimimba: “The Strategic Plan is part of the major strides the Authority is undertaking in its quest to further enhance the medicine regulatory system in the country. It comes at a time when PMRA has undergone functional review aimed at establishing new organizational structure in line with the PMRA Act, 2019 and formal WHO global benchmarking whose outputs include an institutional development plan (IDP) and a roadmap towards achieving WHO Maturity Levels II & III of a functioning national regulatory authority.”

The U.S. Agency for International Development (USAID) through its Promoting the Quality of Medicines Plus (PQM+) program supported the development of the SP.

PMRA employees urged to embrace professional integrity at workplace

Pharmacy and Medicines Regulatory Authority (PMRA) Director General, Mphatso Kawaye, has called on members of staff at the Authority to exemplify professional ethical behaviour and say not to corruption in discharging their duties.

Kawaye made the remarks Friday in Lilongwe when he presided over a half-day corruption awareness meeting for management and staff which was jointly facilitated by the Anti-Corruption Bureau (ACB) and PMRA’s Institutional Integrity Committee (IIC).

“Our commitment is to be a corruption free zone and each member of staff has a role to play for us to achieve this status and maintain it,” he said.

The Director General further said, by establishing an institutional integrity committee the Authority had demonstrated commitment to the fight against corruption and urged members of staff to rally behind efforts of the IIC in leading the institution in the prevention of the vice.

He then pledged the PMRA Board of Directors’ and management’s support towards activities of the IIC which he said are for the good of the organisation and the country.

among other topics, participants were taken through an overview of the NACS II and mandate of IIC, overview of corruption, and workplace ethics.

PMRA established the IIC in January this year to spearhead the Authority’s efforts in the fight against corruption in line with the National Anti-Corruption Strategy (NACs II), a government policy document in the fight against corruption.

The corruption awareness meeting was part of a series of activities which the IIC is geared to implement in the 2023/24 calendar year.

PMRA, MACRA court dealers of traditional medicines, broadcasters on TCM adverts

The Pharmacy and Medicines Regulatory Authority (PMRA) and Malawi Communications Regulatory Authority (MACRA) have jointly held orientation meetings with dealers of traditional and complementary medicines (TCM) and broadcasters in Blantyre, Lilongwe and Mzuzu on advertisement and promotion of traditional medicines.

The two organisations were in Blantyre on Tuesday, Lilongwe on Thursday and Mzuzu on Friday to orient the TCM dealers and owners of broadcasting media houses on the regulation of advertisement and promotion of traditional medicines as provided for in the PMRA Act, 2019.

Section 68 (2) of the PMRA Act states that advertisement of any medicine or allied substance shall require prior screening and approval by the Authority.

Speaking when he presided over the orientation meeting in Blantyre, Allied Substances Sub-Committee Chairperson Bright Lipenga said regulation of the TCM products advertisements was aimed at ensuring that only true information is being disseminated to the public and that the public makes informed decisions based on this true information.

Said Lipenga: “Production of traditional and complementary medicines at industrial scale has resulted in the need for advertisement and promotion of the same.

“Considering that these advertisements are for specialised products and main target are vulnerable people, some of them who are in a desperate need to be helped, there is a need to regulate information being disseminated to the public.”

On his part, MACRA’s Deputy Director of Broadcasting, Kelton Masangano echoed Lipenga’s sentiments saying the Communications Act, 2016 also empowers MACRA to regulate broadcast media content including advertisements hence his organisation’s decision to work with PMRA on the enforcement of regulation of TCM products advertisements.

PMRA and MACRA in November last year signed a memorandum of understanding (MoU) on collaboration on advertisement and promotion of traditional medicines with the overall objective to jointly oversee operationalisation of the requirement of the PMRA Act to have all advertisements traditional medicines vetted before they are broadcast.

PMRA aware of concerns by medicine store operators

The Pharmacy and Medicines Regulatory Authority (PMRA) says it is aware of the concerns being raised by some medicine store owners and operators under the banner, Medicine Store Owners in Malawi.

A statement by the Authority released on Thursday says while the regulator acknowledges that the issues being raised by the medicine stores are pertinent, the same cannot be discussed now as they are before the court.

Reads the statement in part: “The Authority acknowledges that the issues being raised by the medicine store owners and operators are very pertinent. However, stakeholders and the public may wish to know that the issues in question are also before the Lilongwe High Court. Both PMRA and the medicine store operators are waiting for the court’s guidance on the same.”

The statement further said other related issues which also affect operations of medicine stores in the country are being addressed through new Regulations of the PMRA Act, 2019, which Ministry of Health is currently formulating as part of on-going efforts of improving the country’s pharmaceutical industry.

WHO benchmarking mission concludes with calls for more support to PMRA

A World Health Organization (WHO) mission on formal benchmarking of Malawi’s national medicine regulatory system concluded on Friday with a call for increased technical and financial support towards strengthening capacity of Pharmacy and Medicines Regulatory Authority (PMRA) to effectively carry out its regulatory mandate.

The mission was in the country for a week-long assessment of the status of PMRA’s key regulatory functions in the areas of medicines using WHO’s global benchmarking tool (GBT) with the overall objective of helping in the formulation and establishment of a comprehensive institutional development plan (IDP) for PMRA to address existing as well as potential gaps.

Speaking when the mission presented its findings and recommendations in Lilongwe, Chairperson of the Medicine Safety Committee of the PMRA Board Dr. Lilian Chunda said there was need for stakeholders and partners to join hands with government in supporting PMRA in the implementation of the WHO recommendations.

“We set out expressing interest for this benchmarking exercise exactly for the reason of getting an objective third party assessment so that we know what gaps are there and what we need to do to address them.

“I, therefore, wish to invite stakeholders to support the implementation of the institutional Development Plan so that in a few years to come we are able to realise the gains from this investment by WHO,” said Chunda.

She thanked WHO County Office and WHO-Geneva for investing in the benchmarking exercise and pledged the Board’s commitment to implement recommendations of the benchmarking mission.

Meanwhile, the WHO benchmarking mission team leader Mohamed Refaat said WHO is committed to supporting strengthening of specific regulatory functions of the PMRA as per the mission’s recommendations.

Refaat has since called on PMRA to own the institutional development plan and play leading role in its implementation adding that partners are only there to provide support.

WHO mission in to assess Malawi’s national medicine regulatory system

Pharmacy and Medicines Regulatory Authority (PMRA) is excited to host World Health Organisation (WHO) mission which is in the country for formal benchmarking (assessment) of Malawi’s national medicine regulatory system.

The benchmarking exercise which runs up to Friday, March 31 2023 was launched on Monday at Crossroads Hotel in Lilongwe.

WHO plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe, efficacious, and affordable medical products and health products.

Public Notice: Upcoming registration examinations for pharmacy personnel – 3rd & 4th May, 2023

Pharmacy and Medicines Regulatory Authority (PMRA) hereby announces that Registration Examinations for Pharmacists, Pharmacy Technicians and Pharmacy Assistants will be administered as follows:

Date (s)3rd – 4th May, 20233rd – 4th May, 20233rd – 4th May, 2023
VenueGrand Palace HotelCrossroads HotelCrossroads Hotel

Eligible candidates who are interested to sit for these examinations are requested to confirm to PMRA by submitting duly filled registration application form with all required documents not later than 17h00 of 21st April, 2023.

For further information and/or clarification please contact PMRA on 0212 755 165 / 0212 750 108 or email at info@jjosiah

PMRA establishes institutional integrity committee

In an effort to spearhead anti-corruption efforts within its organization, Pharmacy and Medicines Regulatory Authority (PMRA) has established an institutional integrity committee (IIC).

The establishment of the committee is in line with the National Anti-Corruption Strategy (NACS II), a Malawi Government Policy document which was launched in 2019.

The NACS provides for the establishment of National Integrity System (NIS) which requires each sector to have an Institutional Integrity Committee (IIC) charged with the responsibility of coordinating anti-corruption efforts within institutions.

Speaking on Tuesday at the close of a two-day orientation workshop for the IIC members, which was being facilitated by the Anti-Corruption Bureau (ACB), PMRA’s Chief Human Resource and Administration Officer, Irene Dzanjalimodzi thanked the Bureau for providing technical support towards the establishment of the Committee and training of its members.

Dzanjalimodzi pledged management’s and Board’s support in ensuring that the Committee is fully functional and that it succeeds in carrying out its mandate.

“We are committed to the huge task ahead of us and we are positive that with the help from ACB we will deliver on our mandate,” she said.

On his part, ACB’s Senior Corruption Prevention Officer, George Makande, who was also one of the facilitators at the workshop, congratulated PMRA for establishing the Committee saying the move demonstrates commitment of the Authority in the fight against corruption.

Makande has since pledged ACB’s continued support to PMRA towards operationalization of the IIC.

PMRA revokes licenses of non-compliant pharmaceutical business premises, suspends personnel

Pharmacy and Medicines Regulatory Authority (PMRA) has revoked business licenses of six pharmaceutical premises and suspended one pharmacy technician for six months for breaching relevant laws and regulations under the PMRA Act and pharmacy code of ethics, respectively.

The Authority commenced regulatory action against owners of five medicine stores and one wholesale pharmacy for various offences including operating without a licence, stocking prescription only medicines (POM), operating premises without qualified personnel, and keeping medical products with no proof of purchase.

The six are Abundant Grace, A’s, Felida, Nsanama and Care medicine stores and Karibu wholesale pharmacy.

Rafik Mustaphar, the pharmacy technician, on the other hand, was charged with negligence leading to dispensing of incorrect medication contrary to principles 3 and 5 of the Pharmacy Code of Ethics. He has since been suspended for six months.

PMRA staff in fire safety and first aid training

Pharmacy and Medicines Regulatory Authority (PMRA) members of staff have undergone a two-day in-house fire safety and first aid training at the Authority’s offices in Lilongwe.

The training which was facilitated by Kabula Industrial Safety Specialists brought together all members of staff with first group taking their day-long session on Friday, January 13 2023, while the second group took their turn on Tuesday, January 17 2023.

Speaking, on behalf of Director General, Mphatso Kawaye, when she officially opened the training for the first group on Friday, PMRA Chief Human Resources and Administration Officer Irene Dzanjalimodzi said the training was aimed at equipping the staff with fire safety and risk management skills to enable them prevent office fire accidents and safely manage the same in the unlikely event of occurrence.

Dzanjalimodzi said while the Authority ensures that all necessary precautions aimed at preventing risks of fire are in place in all its offices, it is still vital to prepare members of staff on what to do in times of fire emergences with the view to protect life and property.

“Our goal is to make sure that there are no any fire emergencies here; but in the unlikely event that there’s fire at the office, we need to know how we are going to, first of all, protect our life and that of the next person; and secondly, property,” she said.

Dzanjalimodzi called on the members of staff to apply the fire safety and first aid skills and knowledge acquired from the training, not only at the office, but also in their homes.

Topics covered during the training included emergency evacuation, practical use of various types of fire extinguishers and principles of first aid. The staff were also taken through practical fire drills.