The statement emphasises the role of medicines regulators in efficiently bringing safe, effective and high quality antimicrobial products to the market, as well as minimising the regulatory barriers which can prevent access to essential treatments.
“Antimicrobials are essential to the delivery of modern healthcare.” However, according to the World Health Organisation (WHO), AMR is one of the top ten threats to global public health, economic prosperity and security.
A plethora of challenges await the development, commercialisation and viability of products that tackle AMR. There is a need for modern regulatory systems that can adapt to these challenges. Global regulators must therefore commit to work together to streamline regulatory requirements, without affecting the quality, efficacy and safety of these products. The ICMRA also states that regulators will “commit to develop processes that facilitate the review of emerging technologies, such as phage therapy and point-of-care diagnostics”.
The pharmaceutical industry should also increase their collective investment in research and development. There is an ever-growing need for new antimicrobials that will work when all other options fail, alternative treatments to minimise the use of antimicrobials, and diagnostic products that facilitate sensible and appropriate use. Infection prevention and control is the foundation of modern healthcare, and innovation to tackle AMR must correspond with advancements in other areas to ensure a stable global health system.
ICMRA has also called for continued research in all aspects of AMR, including persistent monitoring of the effectiveness of existing antimicrobial agents and active surveillance of emerging antimicrobial resistance.
In 2017, a single development programme for new antibiotics was unveiled between the United States (US), European Union (EU) and Japan. The aim was to align their approaches to the evaluation of antibiotics, to tackle AMR. Earlier this month, in the fourth tripartite meeting between the countries, further convergence approaches were discussed, including alignment of clinical trial designs. Click here to access a summary of this meeting.
The EMA believes it is the responsibility of various stakeholders to increase investment in research and development, incentivise innovation, improve prescribing principles for antibiotics and ensure adequate media coverage to maintain public awareness.
Regulatory authorities have a crucial role to play in helping the public to preserve the antimicrobials currently available by preventing infections and by reducing overuse and misuse, which promotes resistance, while ensuring global access to antimicrobials for those in need. The global industry is being pushed for innovative new therapies and technologies to help prevent, diagnose and treat infections.
To view the ICMRA’s full statement, click here.