Pharmacovigilance &
Regulatory Affairs

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. It monitors the safety of medicines after they have been authorized for use, playing a critical role in regulatory affairs and public health protection worldwide.

We monitor three major global regulatory agencies: the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the UK Medicines and Healthcare products Regulatory Agency (MHRA). These agencies are the primary authorities for drug safety, pharmacovigilance and regulatory affairs in their respective regions.

Pharmacovigilance is a key component of regulatory affairs in the pharmaceutical industry. Regulatory affairs professionals ensure compliance with laws and regulations governing drug safety, while pharmacovigilance specifically focuses on monitoring and reporting adverse drug reactions and safety signals throughout a medicine's lifecycle. Together, pharmacovigilance and regulatory affairs form the backbone of post-market drug surveillance.

This monitor is designed for pharmaceutical industry professionals, regulatory affairs specialists, pharmacovigilance officers, quality assurance managers, clinical research associates, and anyone who needs to stay informed about drug safety developments and regulatory updates from FDA, EMA and MHRA.

An ICSR (Individual Case Safety Report) is a structured report documenting a suspected adverse drug reaction in a single patient. ICSRs are the primary data source in pharmacovigilance and are submitted to regulatory agencies such as FDA, EMA and MHRA to support ongoing drug safety monitoring.

A PSUR (Periodic Safety Update Report) is a comprehensive pharmacovigilance document submitted by marketing authorisation holders at defined time intervals. It provides an updated analysis of the benefit-risk balance of a medicinal product, incorporating all available safety data worldwide.

PRAC stands for Pharmacovigilance Risk Assessment Committee. It is the EMA committee responsible for assessing and monitoring the safety of human medicines. PRAC evaluates safety signals, reviews risk management plans, and recommends regulatory actions to protect public health across the European Union.

A safety signal is new information on a possible causal relationship between a medicine and an adverse event that requires further investigation. Signals are detected through spontaneous reporting systems, clinical trials, scientific literature, and databases such as EudraVigilance and FAERS.

The FDA (Food and Drug Administration) regulates medicines in the United States. The EMA (European Medicines Agency) oversees drug evaluation and safety monitoring across the European Union. The MHRA (Medicines and Healthcare products Regulatory Agency) is the UK regulatory authority for medicines and medical devices, operating independently since Brexit.

Dechallenge refers to the withdrawal of a suspected medicine and the subsequent observation of whether the adverse reaction resolves. Rechallenge is the reintroduction of the same medicine to see if the reaction recurs. Positive dechallenge and rechallenge results strengthen the causal relationship between the drug and the adverse event in ICSR assessment.