Partners: Läkemedelsverket / Medical Products Agency (MPA)
The Medical Products Agency is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and sale of drugs and other medicinal products. The MPA is a government body under the aegis of the Ministry of Health and Social Affairs. Our task is to ensure that both the individual patient and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner. Together with these other EU authorities, we work to progress and develop the control of medicines within Europe.
One of the MPAs tasks is assessment of non-clinical data (pharmacology, pharmacokinetics and toxicology), being part of applications for clinical trials and approval of medicinal products.
In ESNATS, MPA is a member of the Steering Committee and will, as such, provide advice and requirements on regulatory needs for assay development and specify reference compounds to be tested.
Key staff involved in the project
Ira Palminger Hallén, MSc Pharm, PhD, is a preclinical assessor at the division of preclinical and clinical assessment 2. She holds a PhD in reproductive toxicology and has 12 years experience from pharmaceutical industry in the fields of reproductive toxicology, drug distribution and clinical pharmacology. She has been associate director of a preclinical drug distribution group and later project team leader involved in development of early clinical programmes (phase I) for candidate drugs. Since 2007, she is working at MPA, as assessor of the preclinical documentation in applications for marketing authorisation of medicinal products.