Statement on the revision of the guideline for the approximation of legislation and administrative regulations of the Member States about applying good clinical practice when conducting clinical trials with medicinal products for human use


BIO Deutschland agrees with the appraisal of the European Commission. A one-time submission via a joint 'EU portal' would in fact be welcomed. Such a procedure would bring about a significant relief in the administrative sector, especially with multinational clinical trials, as well as greatly reduced costs for the sponsors.

Sufficient financial resources and manpower would have to be made available to the European Medicines Agency for such a procedure, in order to ensure adequate IT infrastructure for the submission of applications and the relevant documentation as well as the distribution to the Member States concerned.

In addition, such a strong harmonising of data and applications for documentation can be made possible. Moreover it could have a supporting effect when dealing with additional national requirements of individual Member States, if necessary. The Member States should therefore be encouraged to reduce administrative requirements and to remove country-specific requirements from their respective federal legislature, which do not contribute to a greater security and strengthening of the rights of the participants of clinical trials, and to adapt legislature accordingly.

The portal would allow an application to be submitted that is suitable to be reviewed by the proper national authorities and the respective ethics commissions. All applications would be submitted via the portal. It does not matter whether the clinical trial is conducted in only one Member State or several Member States. This would be excellent support for the expansion of the clinical development programme as well as for the inclusion of additional Member States.

The central validation of applications would ensure that standardized requirements would be introduced and published, which would lead to an improvement of a successful submission quote of applications ("first-time-right"). This would especially simplify matters for small and medium-sized companies and is therefore quite welcomed.

When submitting follow-up applications, being able to refer to information that has already been submitted via the EU portal would make managing the dossiers for investigational products much easier. Other sponsors could refer to information already submitted on the basis of a written agreement and additional Member States could be included in the clinical development at a later time.

The use of a reference language (in this case English) would reduce administrative costs for all submissions considerably. The protocol, in the form of a synoptic overview, the form for the written permission of patients after prior clarification, the information sheet for patients as well as specific documents for the respective ethics commission could be translated into the language of the country, in which the clinical trial is to be carried out and also be submitted as country-specific, supplementary documents via the EU portal.

The submitting of applications via a joint EU portal should at the same time bring about the distribution of information and the reviewing of applications for approval in all Member States involved. A review by the proper national authorities and ethics commissions would run parallel. In addition, the use of a standard portal would allow a speedy recheck and approval of the clinical trial, as, for example, the case already is in Germany.