Masterarbeit

Implementing CMC Section of the Clinical Trial Directive

Hiu Wah Yuen (2005)

Language: English

The Directive 2001/20/EC dated April 4th, 2001 was published on 1st May 2001 in Official Journal of European Communities.

Implementation date should be till 1st May 2004. This has had a big impact on the Member States, and 2004 was a year of changes. Due to implementation, the requirements of each Member State changed nearly daily. But now, almost all countries have implemented the directive.

The principal aim is certainly the harmonisation of conducting clinical trials within EU. A lot of effort has and is being made to ensure same and high standards regarding safety and quality in clinical trials. The procedures should be clear and transparent throughout the EU.
But do we have already a harmonisation throughout the EU?

In my opinion, a global or even a European harmonisation has still not yet been reached. But, nevertheless, due to the clinical trial directive a big step has been taken. The main focus of my study of literature is how to include quality data into the IMPD. Especially, quality data in the early phases should be a satisfactory progress to public safety. This should guarantee the quality of the product in the very early phase of development. Thus, implementing the quality part was and is recently a big issue.

All pharmaceutical companies, which are involved in clinical trials, are going forward to improve the strategy of CTA submission as well as their clinical research based on high standards.
The competent authorities have to review much more documentation and they also require more resources to do so in less time with more pressure.

Furthermore, the ethics committees have to get used to their new role, which means the evaluation of documentation also in fixed timelines, but this work is regulated by law.
Finally, it should be pointed out, that the clinical trial directive has changed conducting clinical trials in Man, however an increasing of complexity and cost for clinical trials cannot be avoided.
 
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