Regulatory Affairs

Nuclear Medicine Europe’s Regulatory Affairs Expert Group represents member companies on current, pending, and proposed pharmaceutical legislation, regulations, and specific guidelines. The expert group plays a significant role in continuously monitoring these pending and proposed documents at both national and EU level.

When issues could impact our business, the group may take proactive engagement actions with the European Parliament, the European Commission, and national and EU competent health authorities, as relevant. The group drafts position papers and aims to influence decision-making through its contacts with key regulatory and legislative staff.

On a regular basis, it provides members with news and relevant documents issued by EU institutions and affiliated committees concerning pharmaceutical legislation and market issues. The expert group discusses regulatory topics of mutual interest and aims to agree on common positions for responses to authorities.

Since its creation, the Regulatory Affairs Expert Group has grown in importance and has successfully completed important advocacy actions.