IMB at a glance.
•New Medicines
New medicines for certain conditions including vaccines, oncology treatments and diabetes must be licensed centrally through the European Medicines Agency. A company wishing to secure a licence for a product outside these categories for Ireland has to apply to the IMB.
•IMB Licensing of new medicines
Drug companies must submit all research on the safety and efficacy of a new product to the IMB for analysis. The IMB can ask for more information if it is not satisfied with that available. The new product will be compared to a placebo and existing treatments.
The IMB then decides whether to license the drug for use taking into account the benefits and risks. The IMB processes hundreds of new product applications a year.
•Monitoring
The IMB uses reports from medical professionals, the public and the pharmaceutical firms to monitor suspected adverse drug reactions in patients.
Drug companies must also give the IMB regular safety updates containing global information on reactions to the drug.
•Herbal Treatments
The IMB has a number of staff dedicated to the regulation of traditional and alternative treatments used for medicinal purposes under the Herbal Medicines Directive.
The board is reviewing the more than 2,200 products available and checking how they are manufactured and their quality.
•Staff
The IMB has 210 staff engaged in a range of regulatory activities including licensing new drugs, approving clinical trials and visiting manufacturing sites for pharmaceuticals and medical devices.