Section 124 of the PMRA Act, 2019 mandates the Authority to put in place mechanisms that will promote transparency and information sharing through the establishment of a Quality Management System based on common regional requirements.

The Quality Assurance Office was established to ensure that all regulatory and administrative activities in the Authority are carried out in accordance with Regional and International Recognized Standards. As such the Quality Assurance is responsible for:

1.The development and implementation of the following PMRA Quality Management Systems:

1.1   ISO/IEC 17025:2017: The General Requirements for the Competence of Testing and Calibration Laboratories.

1.2   ISO 9001:2015: Quality Management Systems Requirements

2. Ensuring compliance to the World Health Organisation Global Benchmarking Tool for all PMRA regulatory functions including;

2.1 National Regulatory System (RS)

2.2 Registration and Marketing Authorization (MA)

2.3 Vigilance (VL)

2.4 Market Surveillance and Control (MC)

2.5 Licensing Establishment (LI)

2.6 Regulatory Inspection (RI)

2.7 Laboratory Testing (LT)

2.8 Clinical Trial’s Oversight (CT)

3. Ensuring that Customer complaints and Customer feedback are concisely responded to and ensures that timely feedback is provided to the customers.

Customer Complaints and Customer feedback can be submitted by following this link: Feedback and complaints; or in person at the PMRA reception; as mail at Pharmacy and Medicines Regulatory Authority, Off Chilambula Road, P O Box 30241, Lilongwe 3, Malawi; or via email at info@pmra.mw