Mozambique has made significant progress in strengthening its pharmaceutical systems and improving access to life-saving medicines in recent years. A 2017 medicines act provides a solid legal framework for the regulation of medicines, vaccines, and biological products. Building on this, MTaPS focuses on working with the country to achieve stronger and more efficient medicines regulatory processes and preventing the spread of antimicrobial resistance.
MTaPS focuses on the following technical areas:
MTaPS is working with the National Directorate of Pharmacy (DNF) to incorporate good review practices for regulatory functions to improve efficiency, clarity, and transparency. MTaPS is also supporting the DNF to develop guidelines and standard operating procedures to implement published regulations, including supporting new medicines applications. The 2017 act called for the establishment of a national regulatory agency, ANARME (Autoridade Nacional Reguladora de Medicamentos de Moçambique), and MTaPS will assist the DNF in operationalizing the new agency.
Expanding use of an electronic medicines registration tool
MTaPS is supporting the DNF/ANARME to scale up the use of Pharmadex, a web-based tool that helps streamline and track medicines registration. Work includes improving the functionality of the tool to allow for online submission of registration applications and developing a module for licensing as a step toward expanding its use for other regulatory functions.
Developing a quality management system
A quality management system (QMS) increases legitimacy, prevents mistakes, reduces cost, and has a positive impact on regulatory outputs. MTaPS is assisting the DNF to develop a QMS that will enable the DNF to attain ISO 9001:2015 certification. A harmonized QMS, as recommended by the World Health Organization, also facilitates recognition of regulatory decisions by other national medicines regulatory agencies, including those in the Southern African Development Community.
Establishing a surveillance system for new medicines
In partnership with the University of Washington, MTaPS is providing technical assistance to the DNF to design and implement a plan for monitoring patients treated with new antiretroviral and TB medicines for adverse events. This includes developing a protocol for active surveillance; training health care providers on the protocol; and introducing tools for quality data collection, analysis, and utilization for clinical decision making.
Optimizing the use of antimicrobials through multipronged interventions led by Drug and Therapeutics Committees (DTCs) can help reduce the emergence of antimicrobial resistance. MTaPS is building DTC capacity in selected hospitals, including training on implementing antimicrobial stewardship audits and applying quality improvement approaches to improve antimicrobial use.