• Manoj Swaminathan

Regulatory Intelligence in Pharmacovigilance

Updated: Aug 11

Pharmacovigilance requirements are constantly evolving and one may not find it difficult to monitor the requirements in EU, US, Canada, Australia, Japan, India, New Zealand, Singapore, Switzerland etc., as these are available in English and we know where to find them. However, we still need to periodically monitor if anything has changed, as any delay may affect Pharmacovigilance compliance.

The problem is mainly with countries where requirements are published in the local language or may not be available over the internet. At times, a scanned document in local language my be available on the internet and make it really difficult. Suddenly one may receive a request from these countries to submit a PSUR, RMP or even a PSMF. If this happens during renewal, then one may not have so much time unless the regulatory agency is willing to provide an extension. At times, the agency may even request to provide the 'local' Pharmacovigilance contact person.

The countries in the European Union follow a common regional Pharmacovigilance guideline. Such measures are even being considered by other regions such as the Middle East (Common Arab Guideline) and even South America. However one needs to be careful if there are additional local requirements in some of these countries.

All these calls for a strong regulatory intelligence system in Pharmacovigilance and the company may either manage it in-house or even plan to outsource, where the authenticity of information is the ultimate responsibility of marketing authorization holder (MAH).

One can consider maintaining a database (even an excel should do), with the following information, that may not be limited to:

  • Country details

  • ICSR Requirements and reporting methodology

  • PSUR Requirements and reporting methodology

  • RMP Requirements

  • PSMF Requirements

  • Need for Pharmacovigilance contact person - Local? Regional? Outsourced?

As Pharmacovigilance requirements are constantly evolving the information is dynamic and one may even consider a part-time or full-time resource to handle this important activity. Some companies even evaluate automation measures. It is then the role of PhVQA to ensure compliance with respect to local requirements in these countries. These days it is not unusual to receive inspection notifications from such developing countries and hence it is important to have a robust Pharmacovigilance intelligence system in place.