Regulation harmonisation

As the PEA does not allow iimovation and the enforcement of the law is a major problem, a new food law is underway. It will ensure safety and quality for consumers, bring about greater transparency, self-regulation, harmonisation of standards and mles, and give a boost to the country s agriculture processing industry [95]. 

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances... 

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

Supplementary requirements for specific types of drug products are contained in other Parts ofGhapters 9 and 21 of the Gode of Federal Regulations, as summarised in Table 11.1. IGH Q7 guideline provides globally harmonised principles ofGMP for APIs. 

An essential aim of future law-making procedures is to harmonise international recommendations and agreements with national and European regulations. 

Although European Directives have been issued on legislative requirements for food contact plastics, European harmonisation of regulations for rubber or thermoplastic elastomers used in contact with food is yet... 

The establishment of internationally harmonised and consistent regulations, codes and standards is essential for the commercialisation of hydrogen-based products and systems. 

ICH Q2B. Validation of Analytical Procedures Methodology. ICH Harmonised Tripartite Guideline, November 1996. http //www.fda. gov/ downloads/Regulator%20yInformation/Guidances/UCM128049.pdf. Accessed on 04th September 2012. 

European Commission (EC) (2011) Health and Consumers directorate general. Implementing measures in order to harmonise the performance of the pharmacovigilance activities provided for in Directive 2001/83/EC and Regulation (EC) No 726/2004. Brussels, SANCO/D3/FS/cg/ ddgl.d.3(2011)1003866... 

The EU has approved Council Directive No. 92/28/EEClO (of 31 March 1992, now consolidated as Articles 86 to 100 of Directive 2001/83/EC) on the advertising of medicinal products for human use, thus bringing Member States into line with common requirements and standards. The UK regulations have been amended to comply with the Directive. The Directive, Part IV of the UK Medicines Act 1968 as amended by the Advertising Regulations, and the ABPl Code of Practice for the Pharmaceutical Industry are broadly in line with one another. The commentary below on promotion relates primarily to the United Kingdom. While there have been some moves towards the international harmonisation of controls on promotion, these have had only a limited effect, despite the fact that in Europe, Member States all comply with Directive 92/28. 

Requires FDA to support the office of the US Trade Representative to reduce the burden of regulation and harmonise international regulatory requirements consistent with the purposes of the FD C Act. 

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