Post-marketing surveillance (PMS) is the system in place for monitoring of the known and unknown side effects of pharmaceuticals with the main sources for this information being physicians or pharmacists. This is a mandatory system that is the responsibility of the marketing company to administer but requires that the results be reported regularly to the regulatory agencies. Access to medicines is carefully controlled through the issue of prescriptions and availability through pharmacies or hospitals. In contrast, foods are widely available without prescription through retail outlets which means that the PMS system for drugs and medicines cannot be applied for food products. The main feedback on health concerns will come directly from consumers, often into company carelines, and therefore a different system of surveillance is required. To differentiate between PMS and the approach for foods, the term post-launch monitoring has been coined.
KeywordsGenetically Modify Retail Outlet Acceptable Daily Intake Estimate Daily Intake Marketing Company
References and Further Reading
- Commission of the European Communities (2000) Commission Decision 2000/500/EC of 24 July 2000 on authorising the placing on the market of ‘yellow fat spreads with added phytosterol esters’ as a novel food or novel food ingredient under Regulation (EC) No. 258/97 of the European Parliament and of the Council. Official Journal of the European Communities No. L 200, p 59Google Scholar
- EFSA (2011) Guidance on the post-market environmental monitoring (PMEM) of genetically modified plants. EFSA J 9(8):1–40 Google Scholar
- FSANZ (2007) Final assessment report proposal P291 review of novel food standard. http://www.foodstandards.gov.au/code/proposals/pages/proposalp291reviewof2805.aspx
- Lea LJ, Hepburn P. (2006) Safety evaluation of phytosterol-esters. Part 9: Results of a European post-launch monitoring programme. Food Chem Toxicol 44(8):1213–22Google Scholar