EMA established the group in 2022 to help implement EMA's extended mandate in addressing public health emergencies, in line with Regulation (EU) 2022/123.
This enabled EMA to engage with representatives of the medical device industry, notified bodies and the pharmaceutical industry in order to implement the Regulation.
The group complements other forums for EMA dialogue with industry, such as EMA's industry stakeholder meetings and bilateral meetings with industry associations representing specific sectors.
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Members and mandate
The Industry Standing Group consists of:
- The Chair
- 1 Member and 1 alternate from industry stakeholder organisations
- Observers from:
- EMA Management Board;
- European Commission;
- EMA's scientific committees;
- Coordination Groups for Mutual Recognition and Decentralised Procedures - Human (CMDh)
- Coordination Groups for Mutual Recognition and Decentralised Procedures for veterinary medicinal products (CMDv)
- Medical device notified body organisation.
Active Pharmaceutical Ingredients Committee (APIC)
Alliance for Regenerative Medicine (ARM)
Association of Clinical Research Organizations (ACRO)
Association of the European Self-Medication Industry (AESGP)
Association of Veterinary Consultants (AVC)
European Association of Authorised Representatives (EAAR)
European Association for Bioindustries (Europabio)
European Association for Logistics and Transportation in Healthcare (EALTH)
European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR)
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
European Contract Research Organization Federation (EUCROF)
European Federation of Pharmaceutical Industries and Associations (EFPIA)
European Healthcare Distribution Association (GIRP)
European Industrial Gases Association (EIGA)
International Plasma and Fractionation Association (IPFA)
Medtech & Pharma Platform (MPP)
Nuclear Medicines Europe (NMEU)
Meetings
The group meets four times per year. For more information, see the dedicated meeting page:
EMA also hosts industry stakeholder meetings where members discuss operational aspects linked to medicine development, the centralised procedure and pharmacovigilance:
In addition, EMA organises bilateral meetings with industry associations:
EMA working parties also discuss related issues: