The objectives and achievements of medicines regulations in the Nordic countries
The primary objectives of drug regulatory activities in the five Nordic countries (Denmark, Iceland, Norway, Sweden and Finland) are essentially the same.
Iceland and Norway have the lowest number of medicines on the market with Denmark and Finland having around twice that number.
The number of new drug approvals in Norway is lowest due to the implementation of a ‘needs’ clause.
For two decades the Nordic countries have strived to harmonize their regulatory procedures. Many guidelines have been produced by The Nordic Council on Medicines to simplify registration processes for the pharmaceutical industry.
There is no mutual recognition on regulatory decisions between the Nordic Countries and there are no plans to create a central regulatory agency for the Nordic countries.
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