15.04.2026
The ADRA project (Dosage review and adjustment of selected veterinary antibiotics) was launched in the EU in 2021 and is concerned with minimising the emergence of resistance and ensuring the availability of first-line veterinary antibiotics. For the relevant antibiotics, some of which were authorised decades ago, their approved Information for healthcare professionals is no longer up to date with current scientific knowledge. Therefore, the dosage regimens (i.e. dose, frequency and treatment duration) may require a critical evaluation so that they are adapted to the current conditions for the desired level of safety and efficacy, while at the same time limiting the selection for resistant pathogenic bacteria. As of the end of 2025, the updates are being developed sequentially within the EU for prioritised groups based on "active substance-target animal species–route of administration–pharmaceutical form–disease" and will subsequently be recommended by the EMA. The initial recommendations for the updating of the information for healthcare professionals are expected at the end of 2026 – start of 2027.
Swissmedic will adopt the results of the project for the relevant veterinary medicinal products in Switzerland as soon as specific recommendations, for example relating to changes to dosages and withdrawal periods, are communicated by the EMA. The ADRA project is expected to result in higher dosages for first-line antibiotics, e.g. penicillins and tetracyclines. These higher dosages will most likely lead to longer withdrawal periods. In light of the above, all veterinary medicinal products within the same group (described above) will need to be updated at the same time. The changes will therefore be implemented as part of coordinated standard signal procedures as described in the Guidance document "Drug Safety Signals VMP".
The marketing authorisation holders will need to submit the changes as a signal via the Safety Portal (see Guidance document "Drug Safety Signals VMP"). If no signal is submitted, Swissmedic will open the corresponding procedure itself.
