EMA and EUnetHTA Launch Joint Gateway for Parallel Advice

The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies.

The single gateway will allow for consultation requests with the EMA and HTA bodies in EU member states, in both pre- and post-marketing research, and will help align evidence requirements among regulators so that companies can generate and deliver a single set of data.

The plan will replace the existing framework for seeking parallel scientific advice, which required sponsors to contact member states’ HTA bodies individually. Now, sponsors will need to notify EMA and EUnetHTA simultaneously of their intention to request parallel advice, before EUnetHTA coordinates the involvement of individual HTA bodies.