European Regulatory Agency

One of the main drivers for the development of new pulmonary drug delivery systems has been the potential for noninvasive systemic delivery of protein and peptide compounds. The systemic delivery of macromolecules via the airways would overcome the inconvenience and cost associated with current methods of administration (injection), and appears likely given the large surface area of the airways and the thin pulmonary epithelium. Most research has concentrated on pulmonary delivery of insulin for the treatment of diabetes. Recently, one insulin product has completed phase three studies and is now undergoing review by European regulatory agencies for marketing approval. 

Numerous manufacturing systems are presently available for large-scale expression of recombinant proteins. Bacteria, yeast, mammalian cells, and transgenic animals have all been successfully utilized for large-scale production of recombinant biologies. In most cases the recombinant product is a cloned version of a previously purified human or animal protein thus reference standards are available for comparison. The FDA and the European Regulatory Agency have since developed standards for both the production... 

The repositories of the essential regulatory documents of the European Regulatory Agency (EMEA), the US Food and Drug Administration (EDA) and of the tripartite International Committee of Harmonization (Europe, USA and Japan) (ICH) organization can be found with the following links ... 

The cGMP manufacturing and analytical process (outlined above) and the facility where it took place (Berlex Biosciences, Richmond, CA) have been approved by both the U.S. Food and Drug Administration (FDA) and the European Regulatory Agencies. Based on the test data, the FDA qualified Ad5FGF-4 as a well characterized product. ... 

In April 2008, Oncophage (vitespen formerly HSPPC-96) was approved in Russia for the treatment of kidney cancer patients at intermediate risk for disease recurrence. The company, Antigenics, expects to submit to the European Regulatory Agency before the end of 2008. 

Subsequent regulatory requirements prompted the development of a third generation of products. European regulatory agencies (BfR, formerly the BgW MAFF and SCF) continue to reduce the allowable levels of impurities in food. For example, recent BfR recommendations reduce the allowable levels of DCP and CPD in food contact paper (2). Typical regulated food contact papers are tea bag, coffee filter, and milk and juice cartons. Food contact paper using wet-strength resins can contribute DCP and CPD to food. 

Some twenty-three years ago, European regulatory agencies decided to replace body belts with safety harnesses. The U. S. regulators were not as quick to investigate the technology and require this improved fall protection and fall arrest safety gear. On January 1, 1998, a final rule was passed by OSHA that affects the construction industry. 

What convinced the European regulatory agencies to adopt the safety harness rather than the continued use of the body belt (a safety belt ftiat fastens around the waist) was through the analysis and use of lifelike dummies during drop tests. Additional research has shown that a motionless worker knocked unconscious in a fall could survive only briefly before being rescued if suspended only by the body belt. The belt itself could cause internal injuries and asphyxiation. In a safety harness, a worker could survive the same fall for a much longer period and would be spared most of the injuries caused by a body belt. 

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