Regulatory affairs is the process of registration of drugs. In earlier times, registration of drugs to the market was not bound by much legislation. However, multiple occasions of undesired drug fails (for example the softenon-affaire) were a call for more safety in drug development and drug administration. Nowadays, the drug development industry is regulated with legislation and regulations. In the Netherlands, a drug needs to meet the criteria that are outlined in the geneesmiddelenwet (Gnw).  

The three main topics of this law are: 

• The drug works as expected (efficacy).  

• The drug is (relatively) harmless (safety). 

• Constant and acceptable quality of the drug is guaranteed (quality).  

There are multiple registration procedures, depending on whether the application is international or not.  

Many parties and documents come into play in relation to regulatory affairs. Some of the most important aspects are:

Key organizations

• CBG

• EMA

• ICH-GCP
• ZiN
• Octrooicentrum NL

 Documents

• SmPC

• RMP

• DHPC