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Regulatory Functions

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National Regulatory System

The National Regulatory System provides the framework that supports the WHO recommended regulatory functions. The NRA is the institution in charge of assuring the quality, safety, and efficacy of medical products as well as ensuring the relevance and accuracy of product information. A sustainable, well-functioning regulatory system will ensure an independent and competent oversight of medical products.

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Marketing Authorization

Marketing authorization (MA) refers to a procedure for approval of a medical product for marketing after it has undergone a process of evaluation to determine the safety, efficacy and quality of the product and the appropriateness of the product information.

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Vigilance

Section including information on the Pharmacovigilance related activities of your institution. It might also contain the definition of Pharmacovigilance. As per the WHO Global Benchmarking Tool (GBT) these activities should be established in the countries based on a risk management approach. A reporting system should be established to monitor the safety of medical products.

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Market Surveillance and Control

Market surveillance and control function activities are primarily concerned with four themes: (1) control of import activities, (2) prevention and detection of and response to substandard and falsified medical products, (3) market surveillance program for monitoring the quality of medical products throughout the supply chain, and
(4) control of promotional, marketing and advertising activities. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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Licensing Establishments

The NRA is responsible for coordinating licensing activities and should be supported by published and readily available legal provisions, regulations and guidelines which ensure that licensing of facilities throughout the supply chain is based on compliance with Good Practices (GXP) and that the NRA is empowered to issue, suspend or revoke licenses for premises and establishments. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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Regulatory inspection

The supply chain includes manufacturers, distributors, re-packagers, re-labelers, importers, agents, traders, wholesalers and retailers of medical products. The purpose of regulatory inspections is to ensure that operations at these establishments are carried out in accordance with approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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Laboratory testing

The laboratory testing regulatory function is intended to ensure that the NRA is able to assess the quality of medical products by performing quality tests on them in certain situations. Testing can be a requirement for lot release for certain products depending upon national regulations. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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Clinical Trial Oversight

Clinical trial oversight is aimed at protecting the safety and rights of humans participating in CTs, ensuring that trials are adequately designed to meet scientifically sound objectives, and preventing any potential fraud and falsification of data. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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NRA Lot Release

Lot release is a system specifically established for the regulatory release of specified biological products. The goal of the regulatory function is to ensure the quality, safety and efficacy of biological products through a regulatory release system. For more information, please refer to the WHO Global Benchmarking Tool (GBT).

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News

This part is dedicated to informing the users about recent events. These can include current campaigns, products recall and alerts or meetings and upcoming events.

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