Regulatory

Development of drugs and other products to be ingested by humans (and animals or fish during farming) is subject to strict regulatory guidelines, prepared by national and international authorities. Norwegian drug development is under the authority of Legemiddelverket, while supplements and food are under the authority of Mattilsynet.

At the European level, the European Medical Agency (EMA) has the overall authority, and they prepare guidelines which also apply in Norway. In the United States, both drugs and food are under the authority of the Food and Drug Administration (FDA). In order to coordinate regulatory cooperation across the EU, USA, Japan, etc., an International Committee for Harmonization (ICH) has been established with the responsibility to compile the relevant guidelines.

For a product to be developed into a drug, a supplement or a medical device, it is important to understand which regulations to deal with, and work accordingly from an early stage in product development.

Through the network Life Science Pilot, Catapult Life Science will contribute to skills development within “Regulatory” and, if desired, also be able to arrange courses in this field for our members. For more info, see “Life Science Pilot.”

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