Medical Products Agency (Sweden)

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The Medical Products Agency (Swedish: Läkemedelsverket) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics.

Its task is also to ensure that both individual patients and healthcare professionals have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner.

The Swedish Medical Products Agency is one of the leading regulatory authorities in the EU. During the last five years, the Swedish MPA has been among the top three agencies in Europe, counting the number of approvals processes managed for central (ie. European) approvals of medicines. The Swedish MPA also has strong representaion in more than 110 working groups and committees in the scope of the Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) for regulation of medical products in Europe.

The Medical Products Agency is a government body under the aegis of the Swedish Ministry of Health and Social Affairs (see Government agencies in Sweden). Its operations are largely financed through fees. Approximately 750 people work at the agency; most are pharmacists and doctors.

The Innovation Office[edit]

As of January 2013, the Innovation Office at the MPA has been established to provide guidance on regulatory issues as well as assistance in contacts with the agency. The Innovation Office is open to all innovators in academia and industry seeking advice and further knowledge about the European market for medical products. The Innovation Office also provides the Regulatory News newsletter about European regulatory affairs.

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