Focus Topics

Reliance is one of the focus topics of the International Pharmaceuticals Regulators Programme (IPRP) and is strongly supported by the IPRP members.

Use of reliance approaches means moving to a more innovative, effective way of working, based on trust and relying on the outputs of other national regulatory authorities (NRAs). Reliance is relevant for all resource settings.

Leveraging the output of other regulators makes the global regulatory oversight more efficient and helps the work of regulators, allowing the allocation of resources to value-added regulatory functions, that cannot be undertaken by other authorities. In addition, reliance can result in more evidence-based, better-quality decisions by making the best use of the global expertise and can increase the efficiency of a regulatory system in a country or region.

“Electronic product information” refers to product information of medicines (e.g., summaries of product characteristics, package leaflets) provided by the manufacturer and/or authorities in any electronic format (e.g., unstructured PDF or semi-structured HTML, XML), which is adapted for electronic use and facilitates dissemination via the worldwide web, e-platforms and print.
 

• Directly linked with approval and safety measures
• Up-to-date and reliable information
• Open access, easily accessible, preferably Interoperable.
• Environmental friendly; less paper
   

In order to provide electronic product information efficiently via the Internet, the following needs to be established on top of internet access.

• Database for storing electronic product information
• Interfaces for submission, review and provision of electronic product information

• Constant & on time update of electronic product information upon approval or change on product information 
   

  

• Reliability:
  “Singular point of trust” Product information should be properly reviewed and always updated.

   

• Convenience
  Product information should be open access, easily accessible, preferably Interoperable.
  • For Health care professionals
  • For Patients