Regulatory authorities in Europe

Various regulatory authorities in Europe (e.g. European Standard or Norm, EN British Standards, BS Germany, DGHM France, AFNOR) and North America (e.g. Food and Drug Administration, FDA Environmental Protection Authority, EPA Association of Official Analytical Chemists, AO AC) have been associated with attempts to pro-... 

Once adopted, VICH recommendations replace corresponding regional requirements. This initiative has clear benefits to sponsors in that a single data package should now satisfy the regulatory authorities in Europe, the USA and Japan. 

In 2006, the combined worldwide pharmaceutical market was around US 643 billion. The distribution of the market (in US billion) is shown in Table 1.1. From this data, it is evident that the United States, Europe, and Japan account for almost 85% of the worldwide pharmaceutical market. The regulatory authorities in these countries are hence very important to the pharmaceutical companies to ensure their products are approved for commercialization. 

The history of the regulatory authorities in the USA was very different from those in Europe (and the rest of the world) in 1954. The greater maturity of the US regulations was the primary reason... 

Hypoalgesia ICH (International Conference on Harmonization) Diminished sensitivity to a noxious stimulation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to harmonise scientific and technical aspects of product registration. They make recommendations which will be adopted by the national / EU authorities after an approval process. 

Initially, over a period of four decades or so, individual regulatory authorities in the United States, Japan and across Europe established their own... 

Analysis of regulatory applications by the health authorities in Europe, Japan and United States reported (2003 ICH Working Report) that near equal representation of both women and men were observed. 

Significant discussion has been provided from the International Conference on Harmonization (ICH), which attempted to harmonize the requirements of regulatory authorities in the United States, Europe, and Japan (Chapters 6, 9, 11, and 15). 

The last, but by far not the least, step before launching a new modern biopharma-ceutical to market is the approval by a regulatory authority. In the US the regulatory authority is the FDA and in Europe it is the EMEA. Since the requirements as well as the procedures for approval can vary quite significantly between these two authorities, we will present both. 

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