Monitoring of drug safety

The Good Pharmacovigilance Practice (GVP) guideline is a set of modules covering all aspects of pharmacovigilance. It defines how the safety of medicines should be monitored and controlled after they have been authorised. The GVP guidelines aim to ensure that pharmacovigilance is carried out consistently and effectively in the European Union (EU). They cover aspects such as adverse reaction reporting and analysis, risk management and quality assurance. The European Medicines Agency (EMA), which works closely with the national regulatory authorities of the EU Member States, is responsible for implementing and monitoring the guidelines.

A risk management plan (RMP) must be submitted at the time of application for the marketing authorisation of a medicinal product. The risk management plan is therefore an integral part of the marketing authorisation. The requirements for an RMP are laid down in the GVP module V (risk management systems). Depending on the type of marketing authorisation application (e.g. for a generic medicinal product or a medicinal product with a new active substance), the requirements may vary considerably.  As not all facts are known at the time of marketing authorisation for a new active substance, the RMP must describe both known and suspected potential risks and define appropriate risk mitigation measures.

Adverse reaction reports (ADRs) are reports of harmful and unintended reactions to a medicinal product. ADRs can be reported by patients or healthcare professionals. The processing of adverse reaction reports is essential for monitoring the safety of medicinnal prducts. They help to identify potential risks, take actions if necessary, and update information for healthcare professionals and instructions for use if new risks are identified. Patients and healthcare professionals are encouraged to report adverse reactions. Many countries have specific reporting forms or online platforms through which such reactions can be reported. HWI's pharmacovigilance department processes these adverse reaction reports for its clients and carries out the necessary submissions to the relevant regulatory authorities.