q-report-cover-oct-2016-to-jan-2017Our blog today, taken from our latest quarterly policy and regulatory affairs update, takes a look at clinical trials hot topics.

Revision of first-in-human clinical trials guideline

Following on from our comments in our last quarterly updates regarding the tragic incident which occurred during a Phase I clinical trial in France in January 2016, the BIA has kept a watching brief on the investigations and any implications for the conduct of first-in-human trials in the EU.

The European Medicines Agency (EMA), in cooperation with the European Commission and EU Member States, has proposed a revision of its guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products to further improve the safety of trial participants.

The EMA published the draft revised guideline for public consultation on 15 November. This follows an initial consultation in the summer on a concept paper that outlined the key areas of the current guideline (adopted in 2007) that need to be amended, taking into account the lessons learnt from the tragic incident, as well as the evolution of practices in the last 10 years.

While the 2007 guideline focused on the single-ascending-dose design used at that time, the practice for conducting first-in-human clinical trials has evolved towards a more integrated approach, with sponsors conducting several steps of clinical development within a single clinical trial protocol. For example, these trials may also include collection of data on food interaction, in different age groups as well as early proof of concept / proof of principle parts and bioequivalence of different formulations.

The BIA intends to respond to the consultation in collaboration with EuropaBio (the European Association for Bioindustries). If members wish to contribute to the consultation response please contact Christiane Abouzeid at cabouzeid@bioindustry.org.

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BIA attends EMA meeting on EU Clinical Trials portal and database

In November the BIA participated upon invitation in an EMA stakeholders meeting on the development of the EU clinical trials and Union database as part of the implementation of the EU Clinical Trials Regulation. Discussions focused on user management – a set of features and capabilities that manage user access to the clinical trials system functions according to their role, so the system will display the appropriate data and also the appropriate activities for them.

We will continue our ongoing dialogue with the Agency in order to address industry concerns and ensure that the clinical trials system is fit for purpose.

BIA responds to EMA consultation on clinical trial guideline

In December, the BIA inputted, together with EuropaBio, to a consultation by EMA on a draft guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials in connection with the implementation of the EU Clinical Trials Regulation. This guideline is of particular interest to members involved in clinical development of biological and biotechnology derived medicinal products in the EU.

Voluntary Harmonisation Procedure (VHP) for clinical trials – 1000th procedure

The Heads of Medicines Agencies’ Clinical Trials Facilitation Group has recently announced receipt of the 1000th application for the evaluation of a multinational clinical trial by the VHP procedure. Established in March 2009, the VHP is a useful tool for the initiation of the authorisation procedure for clinical trials in more than one EU member state by submitting a single application. It is worth noting the VHP served as a model for the new procedure in the EU Clinical Trials Regulation, which will come in to force in October 2018.