Wednesday, 27 March 2019

Global approach to development of new antibacterial medicines


Antimicrobial resistance is a global public health problem. Regulators in the EU, the USA and Japan have had extensive discussions over the last few years to explore and agree how to align as much as possible their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The revised guidance reflects the outcome of these discussions. In addition, it offers clarification on the clinical development of antibacterial agents that are expected to address an unmet medical need, in accordance with experience.

The emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases. Combatting this threat, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network.
Antimicrobial resistance is when a microbe evolves to become more or fully resistant to antimicrobials which previously could treat it. Antimicrobials include antibiotics, which kill or inhibit the growth of bacteria.

A well-known example of a bacterium that is resistant to a number of antibiotics is meticillin-resistant Staphylococcus aureus (MRSA), which has caused infections that are difficult to treat across the European Union (EU).

The emerging and steady increase in the occurrence of bacteria that are resistant to multiple antibiotics has become a global public health threat due to the lack of therapeutic options to treat certain infections in humans.


Specific advice has also been added with regards to the EU regulatory requirements to develop medicines for the treatment of uncomplicated urinary tract infections and gonorrhoea. The draft revised guideline was adopted by EMA’s human medicines committee (CHMP).

See: https://www.ema.europa.eu/en/news/revised-guideline-aims-strengthen-global-approach-development-new-antibacterial-medicines

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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