The urgency of effective responses tothe COVID-19 pandemic and the reliance of many low-incomecountries on imports of medical products, requires newapproaches to regulation of these products. The challengewill be particularly acute for the new tests to identifyinfection, drugs to alleviate symptoms and machines to aidrecovery as well as vaccines that are all expected to bedeveloped in the coming months. Increased transparency,information sharing and greater cooperation among agenciesresponsible for the approval and inspection of medical goodsaround the world can help officials in low-income countriesimplement their mandate more effectively while maximizingefficient access to these commodities. Responsible agenciesshould focus on implementing technical regulations toprotect health and safety, including interception ofcounterfeit and substandard products, and avoid wastingresources and creating delays by maintaining proceduralpractices that may be better addressed through alternativerisk management strategies or seeking to regulate qualityissues, which are best left to the market. Where there is aneed to rapidly approve, test and inspect new goods orvarieties that have not previously been imported, such asnew equipment and medicines, the adoption of mutualrecognition and/or equivalence can provide effectivemechanisms to avoid regulatory delays while maintaining highlevels of safety.
PDF
download
878987797
028-85220240
