Marketing monitoring

One critical issue may be that of immunogenicity. This must always be investigated, and a plan for a post-marketing monitoring must be included in any generic biological product application. 

A device which needs no specific marketing monitoring i.e. self-policing after public education. 

Directive 93/339/EEC on Checks for Conformity with the Rules on Product Safety of Imports states that products may not be placed on the Community market unless they conform to the rules applicable whereas member states are, thus, responsible for carrying out checks on their conformity. Furthermore, customs authorities must be closely involved in the market-monitoring operations provided for under Community and national rules. Customs authorities shall suspend the release of goods or batch and immediately inform the national authorities, who shall take suitable action. The conditions for suspending products release from customs and notification of the national authorities are ... 

In-market monitoring information mnst be assessed for each area of fnnction reviewed, as appropriate. Level 1 assessments are recommended only when all the following conditions occur ... 

In-market monitoring reveals any adverse effects reported for the new ingredient, metabolites, secondary effectors, or source. 

Virtually all other models used to assure the safety of ingested or inhaled substances are variations of the food and drug safety models (described below) the nutrients model based on dose-response relationships the in-market monitoring and surveillance model the novel foods and food additives models, based on a reasonable certainty of no harm and the drug model, based on risk-benefits assessments. 

A different approach to ensuring food safety is in-market monitoring and surveillance. For instance, once an infant formula is released for general consumption, FDA requires that the manufacturer maintain and analyze records of consumer complaints. Further, the manufacturer is required to report to FDA cases where the evidence suggests a reasonable possibility of a link between consumption of the formula and an infant illness, death, or a reduction in intake of required nutrients. This is currently a passive system that merely requires that a caregiver report a suspected case, but it is one more mechanism by which the safety of infant formulas can be monitored. Details of in-market monitoring and surveillance are discussed in Chapter 7. 

RECOMMENDATION A systematic plan for continued in-market monitoring and long-term surveillance should be an essential part of submissions for regulatory agency review in assessing the safety of ingredients new to infant formulas. 

The criteria used to determine the choice of level of assessment and strategies to be utilized are based on the previous discussion in this chapter of conditions under which potential adverse effects of a new ingredient added to infant formula might have been missed in preclinical or clinical trials. Regardless of the level that is chosen, it is expected that systematic data collection procedures (level I assessment) or systematic review procedures (level 2 assessment) will ensure that in-market monitoring information will be assessed for each area of function reviewed in Chapter 6. 

The choice of level 2 assessment for in-market monitoring must occur when any one of the following conditions occurs ... 

There is evidence of some type of adverse effect detected during preclinical or clinical studies. This means that even if potentially plausible alternative explanations are offered to explain adverse findings, level 2 in-market monitoring is warranted since adverse effects were reported. 

Establish expert panel to evaluate ir>market monitoring-review submitted evidence surveillance data, and orrgoin... 

Figure D-14 illustrates proposed in-market surveillance guidelines. Assuming that the recommended preclinical and clinical tests using probiotics detected no adverse effects, passive surveillance for in-market monitoring and level 2 long-term follow-up strategies are recommended. Chapter 7 provides more information about the committee s recommendations on in-market surveillance.

FAO—Trade and Markets Division. Oilseeds market summary, http //www.fao.org/fileadmin/templa tes/est/COMM MARKETS MONITORING/Oilcrops/Documents/Food outlook oilseeds/Food oudook Nov 12.pdf November 2012. [accessed 02.07.14]. 

European Commission Joint Research Centre. 2013. Analysis of needs in post-market monitoring of food additives and preparatory work for future projects in this field. http //www.efsa.europa.eu/en/supporting/doc/419e.pdf (accessed March 21, 2014). 

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