BIA Responds to Clinical Trials Regulation

The UK BioIndustry Association (BIA) has inputted together with EuropaBio, the European Association for Bioindustries, to an important consultation by the European Medicines Agency (EMA) on proposals on how the transparency requirements of the EU Clinical Trials Regulation will be applied to data and information in clinical trial applications which will be stored in the new EU database.

In addition to responding to questions in the EMA’s consultation document regarding its proposals, the BIA has also supported calls for the EMA to consider further issues of relevance, including:

• A deferral for disclosure of information and summary results from Phase I trials, noting the commercial sensitivity of information on these trials
• Considering how to ensure adequate protection of sensitive and commercially confidential information in relation to clinical trials on products without a marketing authorisation
• Ensuring alignment between these proposals and existing EMA policies regarding the preparation of clinical study reports to provide consistency and avoid unnecessary bureaucracy.

        Commenting, Steve Bates, CEO of the BIA said:

“Making Europe a globally attractive location for clinical research is essential for UK economic growth and creating highly skilled employment opportunities in the UK life sciences sector. The BIA is delighted to work with our European sister organisation to ensure that the implementation of this important piece of legislation supports the growth of the bioscience sector in the UK and across Europe.

The UK is fortunate to have the EMA based in London and to have in the Medicines and Healthcare Products Regulatory Agency (MHRA) a globally leading regulatory agency. By working successfully to influence the European agenda, we can deliver most benefit back to the health of UK bioscience.”

Commenting, Christiane Abouzeid, Head of Regulatory Affairs of the BIA said:

“In our response to the European Medicines Agency (EMA)’s consultation on this issue, the BIA has supported the need for a balanced approach to be taken that respects both the rights of patients and the public to be able to access information held on the EU database concerning ongoing clinical trials, as well as the needs of developers and researchers to protect their investments and cutting edge research and development of new innovative medicines.”