The European Medicines Agency (EMA) is organising a workshop on the development of new medicines to treat tuberculosis (TB). The event will take place at EMA’s premises in London on 25 November 2016, from 9:00 to 16:00.

Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. However, regulatory activities are only one element of the comprehensive and multifaceted response needed to encourage and accelerate development of new antibacterial medicines that meet patient needs.

The European Medicines Agency (EMA) has launched a public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB). The guidance is an addendum to EMA’s guideline on the evaluation of medicines to treat bacterial infections.

The use of certain antimicrobials in animals and humans is associated with resistance to these antimicrobials in bacteria from animals and humans. There are also important differences in the consumption of antimicrobials in animals and in humans between European countries. These are some of the findings of the first integrated analysis of data from humans, animals and food in Europe published jointly by the European Centre for Disease Prevention and Control (ECDC), the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA).

The European Medicines Agency (EMA) is ready to share its assessments of applications for generic medicines in real time with collaborating regulatory agencies outside the European Union (EU). This initiative aims to facilitate the timely authorisation and availability of safe, effective and high quality generic medicines worldwide.

The European Medicines Agency (EMA) supports European Antibiotic Awareness Day (EAAD), which is taking place on Tuesday 18 November. EAAD is organised every year by the European Centre for Disease Prevention and Control (ECDC). It aims to raise awareness of the threat to public and animal health of antimicrobial resistance and the importance of prudent use of antibiotics.

CHMP has recommended granting a conditional marketing authorisation for Sirturo (bedaquiline).

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Deltyba (delamanid) and Para-aminosalicylic acid Lucane (para-aminosalicylic acid), two treatment options for use in combination with other medicines against multidrug-resistant tuberculosis.

EMA's response to TB CAB letter regarding the filing of the drugs delamanid and bedaquiline for market approval.

EMA's response to TB CAB letter regarding conducting drug-drug interaction studies for bedaquiline (TMC207) and delamanid (OPC6783).