Comments invited on draft guidance until 31 January 2017
A public consultation on revised guidance on the development of new medicines to treat tuberculosis (TB) has been launched by the European Medicines Agency (EMA).
The revised guidance takes into account a recent shift towards developing new regimes to treat TB, instead of focusing on single medicines.
Stakeholders can send their comments to the EMA until 31 January 2017 and, in November 2016, EMA will also host a workshop to discuss stakeholders' comments on the revised guidance. This will be broadcast live and comments will be taken into account in the finalisation of the guideline.
In 2014 there were approximately 340,000 new TB cases and 33,000 deaths, mostly from eastern and central European countries. Although the disease is slowly declining worldwide, the burden of TB is still high with around 1.5 million fatalities a year.
Existing treatments for TB are not effective at combatting the disease because they are lengthy, complex and generally show reduced efficacy against MDR-TB. They also impose a heavy burden on patients, families and healthcare systems.
The EMA say that new TB medicines and regimes that are simpler to administer, are of shorter duration, and can overcome drug resistance are 'urgently needed'.
Comments on the draft guidelines should be sent to idwpsecretariat@ema.europa.eu using this form.
Companies marketing medicines for small pets exempt from authorisation must submit their annual return to the Veterinary Medicines Directorate (VMD) by 30 November 2026.
