The role of regulatory affairs professionals in tackling covid-19 related product shortages

After 2 years, the Covid-19 pandemic continues to bring uncertainty and challenges. However, pharmaceutical, medical and scientific bodies are working hard to provide solutions.

While the development of vaccines has been a milestone in the fight against the virus, increasing public awareness about the importance of correctly using medicinal products continues to be a priority for healthcare and pharma professionals. During the ‘Omicron’ wave in January, AIFA, the Italian Drugs Agency, flagged the importance of correctly using antibiotics during a time where Italy is currently facing a supply shortage of azithromycin, an antibiotic often prescribed for the treatment of Covid-19.

Although “there is clear and unambiguous evidence for no longer using azithromycin or other antibiotics in the treatment of COVID-19, as clearly indicated by all international guidelines for the treatment of SARS-CoV-2 infection”, wide-spread use of such drugs could lead to shortages in what is considered a ‘critical weapon’ in the fight against several non-Covid conditions.

What role can be played by regulatory affairs professionals during this time?

In such circumstances, regulatory affairs aims to ensure that all the necessary actions to avoid product shortages are taken.

This can be done by acting on different levels, such as:

• Supply chain
• Parallel import
• Following up post-marketing regulatory requirements
• Ensuring the presence of therapeutic alternatives on the market

In any strategy, there should be awareness that every regulatory decision directly impacts the availability of products to patients. Determining the right approach through the use of extensive regulatory experience can make a real difference in reaching this goal.

With 900 experts in 130+ countries, including a dedicated Italian team with more than 30 professionals knowledgeable on local regulations, ProductLife Group guarantees the right response while providing ad-hoc solutions in accordance with the authority’s needs.

Although ensuring the responsible use of antibiotics is a duty for both prescribers and citizens, extensive legislative knowledge and the ability to consider prompt and proper actions make the regulatory professional a ‘key-player’ in ensuring the availability of products on the market, whilst proactively supporting and linking the authority with healthcare professionals, the pharma world, and most importantly, the people.