Regulatory News

EMA Reveals List of Eligible Industry Stakeholder Organizations

The European Medicines Agency (EMA) on Monday disclosed a new list of eligible industry stakeholder organizations that can consult and cooperate with the agency in specific areas.

The list of 17 organizations includes the trade groups European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe and the Active Pharmaceutical Ingredients Committee.

EMA notes that in order to be more directly involved in EMA activities, industry stakeholders will need to be deemed eligible for engaging in consultative dialogue and cooperation in specific areas, though any industry organization or association may register as an interested party by writing to stakeholdersdb@ema.europa.eu.

Nonprofits that fulfil the following eligibility criteria may apply:

• legitimacy with statutes registered in the EU or European Economic Area (EEA)
• clear mission and objectives and an interest in human or veterinary medicines
• registered in the European Commission EU Transparency registry
• being representative of all its members and affiliations throughout the EU/EEA
• adequate structure.

List of eligible industry stakeholder organisations

Eligibility criteria for involvement in EMA activities