The role of the CHMP in the introduction of medicines

The committee for the evaluation of medicinal products for human use advises on the authorization of medicinal products. How does this committee go about when drawing a conclusion on the authorization of a medicine?  Hans Hillege, one of the two Dutch representatives in the committee, explain and provides an insight into this committee.

"We look at the balance between the efficacy (advantages) and the harmful effect (disadvantages) of a medicine; the actual effect of a medicine on a patient," says Hans. "It is on this that we base our opinions and recommendations to the European Commission. If the balance is favourable, we will advice to grant the medicine access to the market. The committee discusses both new and existing medicines, and can also be asked to look at the implications of a change of package leaflets, for instance. Sometimes we draw the conclusion that a medicine that was admitted should be withdrawn.”

Issuing an opinion
The official name of the committee is Committee for Medicinal Products for Human Use (CHMP). "Each European member state has a representative in the CHMP. Each country has an equal vote, regardless of the size of the country. As a rule, we try to agree unanimously, positive or negative. But if opinions differ, we take a vote and the majority of votes prevail.”

Read the sequel to the interview with Hans Hillege in which he explains what precedes a vote.