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Center For Disease Dynamics, Economics & Policy

Drug Regulatory Approvals and Opportunities for Antimicrobial Innovation

Four images side-by side, bacteria, a patient consultation, growing bacteria in a petri dish, an emergency room scene

In a new landscape analysis, OHT researchers describe the current climate for antimicrobial innovation with a focus on regulatory challenges and opportunities for the approval of new antibiotics in three countries: Brazil, India, and South Africa.

Antimicrobial resistance – a global health threat

Antimicrobial resistance (AMR), a global health and development threat, is regarded by public health experts as a “silent pandemic” that is often overlooked because of competing public health emergencies. Globally, an estimated 4.95 million deaths were associated with antimicrobial-resistant bacterial infections, and 1.27 million deaths were directly attributable to such infections in 2019.

Much has been written about the growing morbidity and mortality caused by antibiotic resistance, especially in low- and middle-income countries.  The problem is frequently blamed on the overuse of antibiotics and appropriately so, but insufficient attention has been given to the underlying problem of lack of access to antibiotics. When patients lack access to antibiotics that work in place of those to which resistance has developed, they are more likely to suffer the consequences of AMR.

Ramanan Laxminarayan, Director, One Health Trust

The problem with new antibiotics

The appropriate use of existing antibiotics and the development of new antibiotics targeting drug-resistant infections can slow the emergence, spread, and consequences of AMR; however, antibiotic research and development (R&D) has not responded to the urgent need for new antibiotics.

A lack of investment in antibiotic R&D explains the failing clinical and preclinical antibiotic pipelines: antibiotics are costly to produce, and their low prices and restricted use do not make their development economical.

While financial incentives and market reforms are deemed critical for sustainable progress, addressing regulatory hurdles to accelerate approval of new antibiotics can also help their development and improve access in emerging markets.

Antibiotics are different from other drugs in many respects, including the need for the periodic introduction of new drugs to replace ones to which resistance has developed and the complexity of trials to identify drugs that are effective against drug-resistant pathogens.

Ramanan Laxminarayan, Director, One Health Trust

Recognizing new antibiotics as a critical unmet need

A landscape analysis by OHT researchers on the regulatory framework for antibiotic approval in three countries — Brazil, India, and South Africa — highlights the importance of explicitly recognizing new antimicrobials. These antimicrobials target serious or life-threatening infections as a critical unmet medical need and formalizing their inclusion in regulatory frameworks for accelerated drug approval.

The National Regulatory Authorities (NRAs) in the three countries have taken steps to expedite the registration of medicines. In some instances, flexibility has been granted in clinical trial requirements for drugs targeting unmet public health needs; however, antimicrobials and multidrug-resistant infections are not explicitly included in the list of eligible drugs and indications.

Global coordination to address AMR

Accelerated drug approvals often involve risk-based approaches or reliance on other countries’ regulatory assessments.  As a result, increasing collaboration and harmonization between Health Authorities are necessary for global coordination in the fight against AMR.

With NRAs from high-income countries working toward harmonization and alignment, the inclusion of less-developed NRAs in bilateral and multilateral collaborations could provide valuable perspectives for regulatory innovations to address AMR at a global level. The COVID-19 pandemic has demonstrated what can be achieved through collaboration and harmonization when countries face global public health emergencies. The international community should leverage this momentum to address other global health threats, including AMR.

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.

“Drug Regulatory Approvals and Opportunities for Antimicrobial Innovation – Perspectives from Brazil, India, and South Africa” – Download the full report here.