Non-interventional safety studies after authorisation of the medicinal product
Non-interventional safety studies after authorisation of the medicinal product are studies with a medicinal product that is authorised for trade which are carried out to confirm the safety profile of a medicinal product, determining the safety risk, to characterise or quantify, or to measure the effectiveness of risk management measures (Medicines Act, article 80). Another name for these studies is non-interventional post-authorisation safety studies (PASS).
Safety studies to be carried out at the request of an authorisation authority, are called ‘non-interventional imposed PASS’ in English and are exempt from the DCRF review framework for non-WMO research with a medicinal product. These studies are reviewed separately by the Risk Assessment Committee (section 107 of the EU guideline 2001/83) or by the CCMO.
In the case of multinational non-interventional safety studies at the request of an authorisation authority in the European Union, the research must be submitted for review to the Risk Assessment Committee or the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA). The answers to frequently asked questions about this type of studies can be found on the website of the EMA.
The CCMO is the reviewing authority for national non-interventional safety studies at the request of the Medicines Evaluation Board (MEB), as is laid down in section 8.8 of the Ministerial regulation Medicines Act (Regeling Geneesmiddelenwet, in Dutch). The CCMO review consists of determining whether the research falls under the scope of the WMO or the CTR, whether the execution of the research stimulates use of the medicinal product and whether the study question can be answered with the chosen design.
A model is available on the website of the EMA that may be used to write the protocol for a PASS study.