Innovation product registration

However, the cost of simple substitution and shallow innovation can be substantial. The new EU regulations on Registration, Evaluation and Authorisation of Chemicals (REACH) are expected to result in a large number of chemicals that are currently freely available to vanish from the market. Formulated commercial products such as inks, adhesives and paints can contain up to 60 individual chemicals in one formulation. If one of these is withdrawn as a result of REACH, the potential costs of reformulation can be very high. 

Hypothesis (5) Chemical innovation takes place not only in chemicals . The invention of snbstance applications and the sale of advantage instead of substances are also part of it. In addition, even extremely small market shares of products with an explicit environmental or health-related quality can indirectly become driving forces of improvement innovations in the entire market. This means that the real innovation processes in the domain of chemicals cannot be recorded adequately either solely by statistics relating to new substance registrations or solely by the classic instruments of market analysis. 

Regulation requiring pre-market registration of products has been indicted in the literature as a major negative factor on innovation. In addition, there is data that these regulations have actually created safety and health problems. 

Second, product and process regulation must be divided into two entirely different types - minimum performance specifications and pre-market registration judgments. Failure to do so will significantly reduce the all-important communication of the results of studies already carried out that could help us improve our sagging innovation rate. 

The resource allocation of R D expertise to registration compliance may compromise future process or product innovation. 

For this reason vaccine formulation tends to follow the traditional routes innovative formulations are rare. Aluminium hydroxide, aluminium phosphate and calcium phosphate are still the only registered vaccine adjuvants for humans. Veterinary vaccines have to rely on the same components, however, a few vaccines containing a mineral oil adjuvant (Marcol) or saponin (Quil A or derivatives) have passed the registration hurdles. It remains to be seen whether and under which restrictions these adjuvants can be used in the EEC after 1996 (see also below in "Additional requirements for veterinary products"). 

For larger companies, the Europecin centralised/multistate procedure will be the only option in order to penetrate the markets with new products as quickly as possible. The fees for this procedure are very high, which is a deterrent to smellier companies since this procedure would be a major investment for them with a small chance of a successful outcome. The procedure is complicated and very formal, which mcdces it difficult for small companies to cope with the requirements. Thus the national registration procedure remains an attractive alternative for smaller companies since the market size is still big enough, even for products with a modest degree of innovation. 

Importantly, for registration in countries of the European Union, the sponsor of a follow-on biologic has to develop a process generating a protein sufficiently similar to the reference product without access to the typically trade-secret-protected innovator s manufacturing process or the manufacturing cell banks. In addition, a signiheant nonclinical safety and clinical program has to be conducted. 

Safety testing and registration costs stand as taU barriers to new amphoteric products limiting opportunities for differentiation through innovation. 

Another interesting innovation is the registration of alipogene tiparvovec, it represents the first gene therapy treatment that has reached the market [15]. The medicinal product consists of the human lipoprotein lipase gene that is encapsulated in a vector derived from adeno-associated vims (AAV), serotype 1. The viral vector will deliver the gene into the cell, in this case a muscle cell, where the gene can be expressed after which the lipoprotein lipase is produced, fii... 

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