Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Investigational Medicinal Product Dossier (IMPD): CHMP/QWP/185401/2004-Guideline (Note for Guidance on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical trials): Comparison of requirements described in this guideline and in additional national guidance documents from exemplary EU countries and the emerging country India. Discussion of the impact on the compilation of a global IMPD for a multi-centre study

Claudia Fischer (Abschlußjahr: 2007)

CHMP/QWP/185401/2004-Guideline (Note for Guidance on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical trials):
Comparison of requirements described in this guideline and in additional national guidance documents from exemplary EU countries and the emerging country India.
Discussion of the impact on the compilation of a global IMPD for a multi-centre study.

Language: English

The Directive 2001/20/EC was the result of years of discussion within the European Community based upon the experience that there exist significant inconsistencies among the national rules. The Directive was published on May 1st , 2001, giving each member state three years to enact its own national legislation, rules and guidelines to implement the Directive. With reference to Article 8 of the Directive 2001/20/EC the European Commission published a series of guidances in order to facilitate the implementation of the Directive into national law of the Member States.

However, directives and guidelines are often of low specificity and therefore leave ample space for interpretation with regard to translation of the rules into national law. Several EU Member States (e.g. Ireland, France, Germany, and Czech Republic) have published guidance documents concerning clinical trial applications and the documents necessary to be submitted to the CA in the course of national implementing of the European Directive 2001/20/EC. When comparing these national guidance documents it becomes obvious that the different national Authorities do have different requests e.g. regarding content of the Investigational Medicinal Product Dossier.

The EU Commission was and is advised to give more detailed explanatory documents for the content necessary to be submitted with a clinical trial application to reach the main objective “full harmonization”. Therefore several concept papers and draft guidances have been issued and in addition references to already existing guidelines (e.g. ICH guidances, CHMP-guidances, GMP guidances. GCP guidances) have been made when updating the detailed guidances published in Volume 10 of the Notice to Applicants.
With regard to the differences in national guidance documents the CHMP/QWP began drafting in 2004 a concept paper for a Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials. Several discussion leads to an adaptation and development of the draft guideline. The final version of the CPMP/QWP/185401/2004 NfG on the Requirements to the Chemical and Pharmaceutical Quality Documentation concerning Investigational Medicinal Products in Clinical trials final has come into operation on 1st October 2006.

Despite the existence of several EU guidelines for the compiling of an IMPD currently there are still many differences in the requirements to be submitted along with the IMPD in different European countries and also worldwide (see India) and this fact has a pronounced impact if the authorisation for a multi-centre clinical trial is applied for.

The requirements for the application and the conduct of clinical trials have increased and its impact on the European Research & Development of new pharmaceutical products must be discussed. Moreover, emerging countries, like India must be taken into consideration. They are getting more and more experienced in conducting clinical trials, they are much cheaper as European countries, and the government makes its country more attractive for foreign companies as scientific research is supported intensively.
If Europe wants to regain its competitiveness and attractiveness for industrial development the EU science base must be strengthened through efforts involving all relevant stakeholders. Further recommendations are decreasing bureaucratic hurdles, tax easements or modifying legal texts and provisions in such ways that clinical trials could be finalized in shorter times in order to get drugs earlier to market.
Finally, it must be stated that it is essential that all parties involved in clinical trials collaborate on an international scale and work closely together towards a full integration and harmonisation of procedures. Moreover this would also lead to a facilitation in the conducting of multi-centre trials either within the EU or worldwide.

Pages: 106