Research calls on regulators to speed up antibiotic approvals


A report by One Health Trust indicates that recognizing antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.

A report assessing the current climate for antimicrobial innovation in Brazil, India and South Africa, reveals that removing regulatory hurdles to speed up the approval of new antibiotics will help improve their development and access.

Antimicrobial resistance (AMR) is a growing challenge for the healthcare industry, as antibiotics are a central part of modern medicine. Appropriate use of existing antibiotics and the development of new antibiotics targeting drug-resistant infections can slow the emergence, spread, and consequences of AMR.

Yet, despite the need for new antibiotics, R&D has failed to respond, mainly because antibiotics are expensive to produce, and their low prices and restricted use do not make their development economical. According to the report, while financial incentives and market reforms are essential for sustained progress, addressing regulatory hurdles to speed approval of new antibiotics can also help improve their development and access.

The Director of One Health Trust, Dr Ramanan Laxminarayan, said: “Antibiotics are different from other medicines in many ways, including the need to periodically introduce new medicines to replace those to which resistance has developed and the complexity of trials to identify drugs that are effective against drug-resistant pathogens.

In a report supported by the AMR Industry Alliance, One Health Trust described the current antimicrobial innovation climate, focusing on regulatory challenges and new antibiotic approval opportunities in Brazil, India and South Africa. South.

The landscape analysis performed highlights the importance of explicitly recognizing new antimicrobials targeting serious or life-threatening infections as a critical unmet medical need, formalizing their inclusion in regulatory frameworks for expedited drug approval.

Recommendations provided to expedite antibiotic approval include:

  • Create a specific category for antimicrobials that target serious and life-threatening infections within the regulatory framework provided for accelerated approval pathways.
  • Leverage existing accelerated drug approval programs targeting TB, HIV, and COVID-19 to expedite approval of antimicrobials targeting serious and life-threatening infections, such as multidrug-resistant infections.
  • Increase the capacity of regulatory authorities to deal with the complexity of AMR and new clinical trials.
  • Promote regulatory harmonization to facilitate adoption of trusted pathways for expedited approval of antimicrobials.

Dr Laxminarayan also noted, “Much has been written about the increasing morbidity and mortality caused by antibiotic resistance, particularly in low- and middle-income countries. The problem is often blamed on the overuse of antibiotics, and rightly so, but insufficient attention has been paid to the underlying problem of lack of access to antibiotics. Rightly, this report identifies the recognition of AMR in regulatory frameworks for drug approvals as an opportunity to improve the wider availability of new antibiotics.


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