Challenge

Post a regular pharmacovigilance inspection by a European Union (EU) National Competent Authority, a pharmaceutical company received a major inspection. The finding stated the requirement to regularly review and document changes in pharmaceutical regulations and guidance. 

EUDRAC were approached by this pharmaceutical company to produce a monthly document of any changes to regulations and guidance relating to the product and services provided by the company.

Approach

EUDRAC has a system setup for the collection of changes in regulations and guidance for the purpose of both its own use and as a service offering. The specific requirements of the pharmaceutical company were introduced into EUDRAC’s system and continue to provide monthly updates to the regulatory external environment on behalf of this company.

Conclusion

Reviewing changes in regulations and guidance is an important part of maintaining a pharmaceutical company’s marketing authorisations. National Competent Authorities consider the lack of this process a major inspection finding at minimum.

Pharmaceutical companies should be reviewing and documenting changes to their external environment to ensure they are fully compliant and are meeting the legal obligations for their products.