New Report on Drug Regulatory Approvals and the Opportunities for Antimicrobial Innovation


JULY 12, 2022 – A new report by the One Health Trust, Drug Regulatory Approvals and Opportunities for Antimicrobial Innovation – Perspectives from Brazil, India and South Africa, describes the current climate for antimicrobial innovation, focusing on regulatory pathways supporting accelerated drug approvals in Brazil, India, and South Africa.

Produced with the support of the AMR Industry Alliance, the report highlights the importance of explicitly recognizing new antimicrobials targeting serious or life-threatening infections as a critical unmet medical need and formalizing their inclusion in regulatory frameworks for accelerated drug approval.

“The growing burden of AMR will need to be addressed with new antibiotics,” said Dr. Ramanan Laxminarayan, Director of One Health Trust. “Unless we significantly rethink and revise current processes for regulatory approvals, the burden of AMR will keep increasing.”

“We are pleased to support the One Health Trust’s important research into these unique perspectives regarding the challenges of AMR,” said Emily Wheeler, Director of Infectious Disease Policy at the Biotechnology Innovation Organization (BIO) and co-chair of the AMR Industry Alliance Research & Science Working Group. “We need to do everything we can to encourage increased access and more robust regulatory coordination in the space.”

The report includes recommendations to accelerate the approval of antibiotics in emerging markets:

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

To read the full report, click here.



date 12/07/2022