Regulatory Focus™ > News Articles > Anvisa Launches Drug and Device Monitoring Program

Anvisa Launches Drug and Device Monitoring Program

Posted 18 September 2014 | By Louise Zornoza 

Anvisa Launches Drug and Device Monitoring Program

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

 

Brazilian regulator Anvisa has launched two programs for monitoring the quality of medicines and health products in Brazil. 

The National Program for Quality Control of Medicines (Proveme) will initially analyze monthly samples of drugs from Aqui Tem Farmácia Popular and Farmácia Popular, while the Monitoring Project on Health Products Marketed in Brazil will monitor health products available in the market such as orthopedic implants, breast implants and equipment.

The information generated under the two projects will be logged in the SGAWeb system, which is also being launched today. SGAWeb allows labs to record samples received, analysis results and analytical reports issued.  

The system was first developed in 2011 by the National Institute of Quality Control in Health (INCQS), in partnership with Anvisa. The goal is for SGAWeb to be used by all of the labs that make up the health surveillance laboratory network, encompassing central, regional, and municipal laboratories, in addition to the provider network.

The agency also launched the Center for Management of Emergency Health Surveillance Information (EVISA). This center is a new unit at Anvisa, which will organize the process of capturing, monitoring and responding to health emergencies. EVISA was inspired by the design of the Global Alert and Response (GAR) public health emergency network, consisting of centers set up in various countries and at the World Health Organization (WHO) in Geneva, and gained momentum with the implementation of International Health Regulation.

(Anvisa)


Tags: Brazil

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe