Pre-marketing phase

In the pre-marketing phase of new drug development national regulatory authorities encourage and evaluate a broad range of experimental methods that come within the definition of clinical trials. 

This can also be called the pre-marketing phase of the drug life cycle. It should be noted that although all this is necessary, it is certainly not sufficient for commercial success. 

The new fee structure, which sees premarket evaluation fees gradually reducing and post-market annual product registration charges increasing, is being phased in over 5 years. At the end of the transition period, revenue from pre-market evaluations will be 60% rather than 80% under the previous arrangements. The revised structure will make TGA s revenue less vulnerable to fluctuations in number of major applications. 

Before the end of phase 3, a decision is taken whether or not to file the compound, what the content and message of the dossier and what the regulatory strategy will be. Also the final decisions will be made on the production for marketing and on the anticipated pre-marketing requirements. This is the pre-filing decision point. 

The pre-commercialisation phase of FC technologies is challenging and uncertain. A new market development phase is said to be near, as FC firms arc developing and unveiling prototypes and pre-commercial products at an increasing rate. However, widespread commercialisation has been announced several times and subsequently postponed an equal number of times. Illustrative are statements by Daimler Chrysler in 2000 that by 2004 a few thousand FC vehicles would be introduced for a targeted price of 18,000 [76]. 

Today, the fuel cell markets are transitioning from small-scale development to pilot-scale test and demonstration. To meet the growing demand for stacks for testing and demonstration, a number of leading fuel cell organisations are currently commissioning production facihties in the prototype and pre-commercial phase [28]. 

Year is year of launch in the U.S. market unless indicated Pre-Cl = preclinical, Ph III = phase III clinical trials (status as of Feb. 1990). 

One of these will be operated on diesel in the year 2000 for a fuel cell client. The catalyst in this ATR unit is capable of operation with the sulfur in diesel (under 200 ppmw sulfur in the liquid phase). Based on this ATR technology, HBT developed a <10 kWe fuel processing system directed at the stationary market. The first group of twenty pre-production units is being built for evaluation by fuel cell developers during late 2000 and early 2001. 

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