Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Could the Global Harmonization Task Force guidance of a standardized harmonized documentation format succeed in global harmonization? ***

Dr. Christine Gillen (Abschlußjahr: 2008)

Comparison of the current status of harmonization on the basis of actual requirements on documentation in selected countries/areas of America, Asia-Pacific and Europe

Language: English

The international commerce of medical devices is increasing worldwide because of aging population and increased spending on healthcare technologies. Medical devices represent a wide range of products spanning from simple bandages to heart clamps. Therefore they are classified according to their risk to patient and user. Already the definition and the classification systems of the medical devices in the different countries reflect the divergence existing in the regulation of medical device registration.

So, in the 90ties representatives of industry and authorities of five member states (Australia, USA, Canada, Japan and Europe) established similar to the ICH harmonization group for pharmaceutical products a task force for medical devices, the GHTF, with the target of harmonization of regulation of medical device registration. In the last 15 years they achieved the development of a global medical device regulation system and published 27 guidances to support this system. One of these guidance documents deals with a harmonized format of registration documentation to facilitate the work of industry and authorities. Here, summaries of the different subjects of the technical documentation should be presented in a defined manner. The guidance is called: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED).

Till now manufacturers still have to take their data of the pre-market phase and represent them in different country-specific ways. The authorities have different review approaches and only little exchange of experience with the devices takes place concerning the registration of a medical device. A harmonization here would lead to time and resource savings in the dossier preparation on the side of the manufacturer and would allow on the side of the authorities an easier review of the data always presented in the same way. So the publication of this guidance and the following implementation of it in the different country-specific regulation should be one of the first steps of harmonization. A further harmonization will be possible to be reached later on by the recognizing of a product approval across regulatory authorities similar to the EU system where the obtaining of a CE mark in one country allows the free movement throughout the EU. But this will take certainly a similar time as already spended.

After 10 years development of the guidance about a harmonized documentation format, the finalisation step is still not done yet. The GHTF members Japan, Australia and EU, have opened their systems for using STED by changing their medical device regulation or giving recommendation to use it, even if in Japan still additional requirements like application forms exist. In Canada and USA still a Pilot Program is in progress to examine the usability of the STED and here the implementation seems still a long way to go. Like in the GHTF member states the acceptance of STED in the rest of the world also varies. But the interest in a global regulation system and with this also in a harmonized documentation format exists, demonstrated by the growing participation of countries in trainings offered by the GHTF.

Pages: 61