Drug regulation registration

Netherlands drug regulation now follow European Union rules. For example, GMP inspection is based on the 1983 European Union guidelines for GMP. Since 1 January 1995, a European procedure for registration has operated in the Netherlands. Now two types of trade licences exist a European licence and a national licence. Products with a European licence may be sold throughout the whole European Union, while the national licences are only valid for the country in which the licence was issued by means of the national registration procedure. 

Registration of drugs, also known as product licensing or marketing authorization, is an essential element of drug regulation. All drugs that are marketed. 

The competitive outcome of drug discovery is influenced by the size of the R D bnd-get (which is a major factor driving mergers in the pharmacentical field) as well as by the availability of human resources, the network of collaborative institntions and biotech companies, and the supportive regulatory environment (such as speedy registration processes and orphan drug regulation). 

The regulations regarding the registration of Western drugs, both synthetic and protein based, are complex, with several different levels of review. We now discuss (Fig. 8.12) the application for registration to import a Western drug into China. 

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