The Food and Drugs Authority (FDA) in a quest to fulfill its mandate to ensure the protection of public health and safety, has declared 2021 as a year of winning public confidence through accountability, integrity and teamwork.
The FDA’s mandate includes registering all products that fall within its purview, before they are given market authorisation; informing and educating the public about regulated products; and monitoring to ensure that regulated products comply with the standards as registered.
According to Mrs Delese Mimi Darko, CEO of the FDA, in order to effectively manage the COVID-19 pandemic her team had to institute unique measures including the introduction of a 72-hour registration period for all PPE’s to help register PPE’s as quickly as possible without compromising on the safety of these products.
Ms Darko made this known during a recent virtual press soiree with some team members and the media. According to the FDA, its outlook on 2021 include:
Zero Tolerance Policy On The Importation Of Unregistered Products – Effective February, 2021, all imported regulated products to be registered prior to their importation.
Intensified Public Education – The FDA shall intensify public education and sensitization activities in all regions of the country. This is to ensure better understanding of our mandate and encourage self-regulation among consumers. We require the support of the media to compliment our efforts.
FDA New Advertisement Statement- In response to industry’s concerns about the length of the FDA’s advertisement approval statement and its implications to cost of air time, it has reviewed the statement from “This advertisement has been vetted and approved by the FDA” to “This advert is FDA approved”.
Introduction of the Food and Drugs Safety Line- to address general myths and misconceptions about food and drugs in the public domain.
Meanwhile the FDA says adequate safety and quality assurance has been done in authorizing the two COVID-19 vaccines to be administered in the country. The two vaccines are Covishield, AstraZeneca Vaccine, manufactured by Serum Institute of India, and Sputnik-V, manufactured by Generium in Russia.
The FDA said no safety and efficacy standards were bypassed or compromised, except that the emergency use authorization pathway allowed for expedited review for the public good.
According to Ms. Darko, the FDA, listed as a World Health Organisation (WHO) Maturity Level Three Agency and a regional centre of regulatory excellence, had a stable, well-functioning and integrated regulatory system to ensure availability of quality safe and efficacious medical products, including vaccines.