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.
The Industry Standing Group consists of:
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:
The ISG Focus Group on Regulatory Science Research Translation had as main deliverable to identify what is needed to accelerate regulatory science research so that research outputs can be accepted and used by different stakeholders in the health system, with a focus on stakeholders using the outputs for their research and development (R&D) or evaluation of medicinal products.
This report summarises the priorities and approaches for pre-competitive research consortia as well as recommendations that should be widely applicable and useful for regulators and stakeholders involved in funding, conducting and translating research outputs into practical applications, to ultimately obtain benefits for public and animal health, and access to safe and effective medicines.