The Medical Products Agency (MPA) is the Swedish national authority responsible for establishing standards and requirements for the development, manufacture and sale of drugs and other medicinal products. Our task is to ensure that both the individual patient and healthcare professionals have access to safe, effective medicines and that these are used in a rational and cost-effective manner. In addition to the control of medicines, the MPA is responsible for providing information about medicines, giving permission to carry out clinical trials, approving licences and controlling natural remedies and other medicine-related products.In carrying out our duties, we act both as a formal regulatory authority and as an informal promotor of the rational development and use of new and existing medicinal products.
The role of the MPA has changed to some extent since Sweden entered the EU. In addition to our national responsibility, we also investigate medicines for decisions at the EU-level, in close collaboration with national drug regulatory authorities in other European countries.
The MPA is a government body under the aegis of the Ministry of Health and Social Affairs with almost 300 employees. Most are trained doctors and pharmacists. The MPA's activities are financed entirely through contracts and fees.
Other tasks
The agency also monitors clinical trials of medicinal products and promotes sound reserach on these products. The regulations, inspection and quality control in manufacturing and distribution of a licensed product is a continuing task. Similarly, pharmacoepidemiology and safety monitoring, professional information and prevention of misuse are responsibilitites of the MPA.
MPA in the EU
The MPA's goal is to participate actively in and influence the EU control system in order to ensure that only safe and effective medicines are available on the European market.
An important part of this European-oriented work revolves around developing new standards and requirements for medicines in the face of rapid scientific discoveries and development of new medicines. The MPA therefore participates actively in EU working parties on, for example, clinical effectiveness and safety matters, biotechnology, quality, pre-clinical safety matters and the monitoring of side effects.
The European approval system affords many advantages. New medicines come to market faster, which of course benefits both patients and manufacturers. Also, by utilizing the collective competence of several national drug authorities, the quality of evaluations can be maintained while avoiding the duplication of work.
