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Quality and Regulation

Quality and Regulation

Within the framework of implementation of pharmaceutical regulation and in order to ensure that medicines fulfill the quality standards established at the global level, improving the availability of effective, safe, and quality medicines, the Pan American Health Organization (PAHO) is conducting technical cooperation projects in accordance with the mandates received from its governing bodies and based on the guidelines of the World Health Organization.

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Technical Cooperation

Strengthening of regulatory systems for medicines

One of the strategic objectives of the Medicines and Technologies Area of PAHO is to offer support to the national regulatory authorities (NRAs) that allows the member countries to develop, implement, and strengthen activities related to regulation of medicines, including vaccines and other biologicals. All of the activities conducted in order to achieve this objective are shown in this section.


Evaluation of National Drug Regulatory Authorities (NRAs)

The main objective of regulation is to guarantee the safety, efficacy, and quality of the medicines available to the population. Thus, the effectiveness of regulation should be judged in terms of the extent to which regulatory functions meet this goal. It is therefore essential to know how to measure effectiveness. One way is to relate it to the end results of each regulatory function and develop measurements that capture regulatory performance.

In 2006, as part of the strengthening of regulatory agencies, the national regulatory authorities in some countries proposed the development of a system for evaluating and qualifying NRAs that would be coordinated by the Pan American Health Organization. Such a system would facilitate and create the optimal conditions for setting up mechanisms to cooperate with other regulatory authorities in the Region and making progress toward potential interinstitutional recognition, with the consequent optimization of human and financial resources.


Evaluation of Essential Medicines, Vaccines, and Biologicals in Support of the Strategic Fund

This section details the technical support procedures and activities adopted by PAHO’s Essential Medicines and Health Technologies Area for the procurement of essential medicines, vaccines and other biologicals through the Strategic Fund, including a description, based on rigorous, transparent, and participatory processes, of the technical evaluation conducted, the basic standards and specifications established, and the monitoring of the quality and safety of products used by the member countries.


Pan American Network of Official Medicines Control Laboratories

The Official Medicines Control Laboratories (OMCL), in their status as entities assigned to the regulatory authorities, have been included in PANDRH since June 2005. At that time the Working Group on Good Laboratory Practice (WG/GLP) was created by recommendation of the Fourth Conference. The OMCLs work in a network system under the coordination of the Working Group on Good Laboratory Practice.


External quality control program of official laboratories for control of medicines

This is a control program to evaluate the performance of the official laboratories for control of medicines developed by the Pan American Health Organization/World Health Organization (PAHO/WHO) since December 2001, with the assistance of the United States Pharmacopeia (USP).


Regional Network of National Vaccine Quality Control Laboratories (RRLNCCV)

This cooperation initiative was launched by PAHO’s Regional Vaccine System (SIREVA). The initiative’s objectives included the development of a framework for action that would make it possible to set up a system for guaranteeing the quality of the vaccines used in the Region of the Americas, with testing by the national quality control laboratories as an essential part of the system. This section reviews the history, objectives, and results of this network.


Pan American Network for Drug Regulatory Harmonization (PANDRH Network)

This hemispheric forum has been engaged in technical activities. Its main objective is to support the harmonization processes by examining specific areas and issuing recommendations on priority matters as well as the harmonized guidelines proposed by the working groups created by this Conference. PAHO serves as the network’s secretariat and has designed this space to detail all the activities of the PANDRH Network.

 

 

Regional Office for the Americas of the World Health Organization
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