Regulatory systems Europe

Figure 2.10 Illustration ofthe interaction of the EDQM with the overall regulatory system for medicines in Europe. Reproduced with permission of EDQM, EDQM, Council of Europe.

After a product has been authorised, the regulatory system operates to keep the quality, safety and efficacy of that product under review and to control the way in which it is manufactured, marketed and distributed. The pharmaceutical legislation in Europe has recently been consolidated and, pursuant to Commission consultation and review, amended. The majority of the amendments are due to come into effect in November 2005. What follows, reflects the state of legislation as at close of 2004. 

The most frequently used BFRs are polybrominated diphenylethers (PBDEs), tetrabromobisphenol A (TBBPA), and hexabromocyclododecane (HBCD). The use of FRs has been growing rapidly in recent years. BFRs are the most often used FRs, and their market is still growing. However, the estimated annual use of OPFRs in Western Europe was almost twice that of all BFRs combined. Many FRs have been banned for use because of their potential toxicity, environmental occurrence, and accumulation in human tissue. FRs taken off the market are likely to be replaced by others. Although the REACH (registration, evaluation, authorization and restriction of chemicals) regulatory system has been introduced in Europe to improve protection of human health and the environment, it is still necessary to monitor FRs in environmental samples [84, 88]. 

Under most regulatory systems, metals are considered under food contaminant regulations rather than FCM regulations. Codex Alimentarius provides international guidance on acceptable limits for metals in foods. In addition, there are some national and EU limits and the Council of Europe has produced... 

The way that regulation contributes to sustainable development is changing significantly. Europe and the OECD countries are moving towards a regulatory system that combines the historic command and control with a system that makes greater use of economic instruments. The debate is more about what economic instruments will be used for what pollution load and how quickly rather than whether it happens. 

ASSE through the ASSE Foundation is paying the Rand Corporation 100,000 to research the risk-based regulatory systems in the UK and Europe because there is evidence (significantly lower fatality rates) to suggest the risk-based system may be more effective than prescriptive standards. 

Regulatory systems for medical devices have an important role in supporting market access to technological innovations, while also ensuring the patients protection. To achieve these goals, the United States and Europe use a combination of premarket... 

The adoption of CADDY within the EU has provided a sound basis for the transfer of regulatory dossiers between industry and regulators. CADDY has been developed from inception to a workable system in 5 years and represents a significant collaborative effort between industry and the regulators drawn from both North America and Europe. This initial achievement has resulted in substantial reductions in compiling, transporting, and handling costs for EU dossiers and has provided a basis for rapid... 

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