- Todos > Quality and Safety: Medicines > Counterfeit Medicines
- Todos > Quality and Safety: Medicines > Quality Assurance
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > Quality and Safety: Medicines > Safety and Efficacy
- Palabras clave > annual report
- Palabras clave > medicines quality monitoring (MQM)
- Palabras clave > medicines regulatory systems
- Palabras clave > pharmaceutical quality - assessment and monitoring
- Palabras clave > pharmaceutical services - building capacity
- Palabras clave > progress report
- Palabras clave > quality assurance system
- Palabras clave > quality of medicines
- Palabras clave > regulatory systems
- Palabras clave > technical assistance
(2018; 45 pages)
Financed by the U.S. Agency for International Development (USAID) and implemented by the U.S. Pharmacopeial Convention (USP), the Promoting the Quality of Medicines (PQM) program works to improve the quality of essential medicines in low- and middle-income countries (LMICs) to help prevent and treat HIV/AIDS, tuberculosis, malaria, neglected tropical diseases, and threats to maternal, newborn, and child health. To achieve this important goal, the program supports the adoption of effective and enforceable policies and legislation; strengthens the regulatory and quality assurance workforce to effectively manage product quality; and harnesses information to increase evidence-based decision-making at all levels. Through these activities and related actions, PQM strengthens regulatory systems and improves the ability of manufacturers to produce quality-assured medicines.
The PQM program has been providing technical assistance to governments and pharmaceutical manufacturers since 2009. Since that time, it has developed or contributed to a significant number of resources that can be useful to implementers of medicines quality assurance programs and to decision makers who must consider the value of investments in medicines regulatory systems and quality manufacturing for LMICs. The purpose of this inventory is to provide easy access to these resources through a regularly updated document.
This inventory consists of four main chapters that span the PQM program’s primary technical areas: regulatory systems strengthening, manufacturing, laboratory strengthening, and quality surveillance. These chapters are preceded by a section of resources that introduce the project and its intervention zone, and are followed by a collection of resources that cut across multiple themes. Those resources are grouped by type and displayed chronologically based on their publishing date in each grouping.
Resource types mainly include:
- Policies and guidelines (providing direction on the necessary procedures, processes, and decisions to implement an activity).
- Reports (detailing the implementation and results of key activities).
- Success stories (highlighting factors that led to impact in the implementation of technical approaches and activities).
- Fact sheets and briefs (summarizing PQM’s achievements through short texts and tables, bullet points, graphs, and other data visualization and presentation techniques).
Titles of all resources listed in the chapters of document are linked to online, downloadable versions of those resources. The annex provides a linked, alphabetical listing of the same resources and also includes a URL and a citation to facilitate attribution by authors who quote or excerpt information therein.