Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Post marketing Activities in Japan compared to EU and USA

Dr. Benita von Glahn (Abschlußjahr: 2008)

Language: English

Regulatory approval of a medicinal product is a major achievement in the development of a new chemical or biological entity as this enables the holder of the license to market the medicinal product in the respective market, where the license is valid. However, the time of the approval is also the start of post marketing activities, which include the fulfillment of post marketing commitments, pharmacovigilance activities, as well as the changes to the approved product in view of quality, safety and efficacy data, which usually represent the majority of these activities.

This master thesis has outlined the different post marketing requirements for the 3 ICH regions Japan, EU and USA and has provided a comparison of these requirements.

Differences in post marketing requirements across the ICH regions result in the following consequences for globally acting companies:

  • Need to establish a pharmacovigilance system that fulfills all global requirements including special requirements like the drug use-results surveys in Japan, the RMP in the EU and the quarterly reporting requirements in the US
  • Need to establish processes and procedures that will allow to adhere to the different reporting needs in view of content, scope and timing for adverse drug experiences, for alert report as well as for periodic reports
  • Need to establish a system for the tracking of post marketing commitments per market to ensure that all commitments are fulfilled in a timely manner
  • Need to establish a system to ensure meeting the timelines for the re-examination in Japan, the renewal in the EU as well as the annual reports in the US to allow continued marketing of the product
  • Need to review all planned changes in view of data requirements for the regulatory submission, approval process and timing for implementation to avoid out of stock situations and to ensure that consistent labeling according to the CCDS is implemented

These consequences imply that there is further need of harmonization throughout the major regions, which may outline a future workplan for the manufacturers associations in these regions.

Pages: 81

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