Two new pieces of guidance, from the EMA and the HTA coordination group respectively, should help companies understand which drugs must undergo an EU-wide joint clinical assessment and how to notify the relevant authorities about them.

The European Commission has published draft procedures for how the European Medicines Agency is to share information relating to joint clinical assessments with the Member State Coordination Group on HTA.

New regulation on  substances of human origin (SoHO) will help improve Europe’s “strategic autonomy” and improve access to such substances, say industry representative.

Coupled with a recent top court ruling, the draft implementing act on CoIs under the Health Technology Assessment Regulation show a general trend towards stricter conflicts of interest rules.

Despite changes, industry remains concerned over the EU implementing regulation that sets out procedures for joint clinical assessments.

Advances in cell and gene therapy, together with the forthcoming EU joint clinical assessments, have raised questions about the ethics of having to use randomized controlled trials to test new advanced therapies.