Module 6: Drug post-marketing follow up and pharmacovigilance

Introduction of drug post-marketing

Usually, new drugs are approved based on the result of clinical research studies, also know as clinical trials, which involves relatively small number of patients selected for the purpose of assessing its safety and efficacy. Once these drugs are released on the market and prescribed to a higher number of people, a post-marketing follow up and close surveillance takes place to monitor their safety.

There are usually several institutions in charge of this surveillance, at regional and national level. Besides, the body in charge of closely following up the drugs marketed in the European Union is the European Medicines Agency (EMA), which puts in place a regulatory framework to monitor drug safety.

Introduction to pharmacovigilance

Pharmacovigilance is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.  An adverse event is any undesirable experience associated with the use of a medical product in a patient.

Pharmacovigilance enhances patient safety and public health by providing reliable information on the risks and benefits of medicines.

In the European Union, he pharmacovigilance legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing authorisations, as well as for patients, healthcare professionals and regulators. The pharmacovigilance legislation aims to reduce the number of adverse events in the EU. It aims to achieve this through:

  • the collection of better data on medicines and their safety;
  • rapid and robust assessment of issues related to the safety of medicines;
  • effective regulatory action to deliver safe and effective use of medicines;
  • empowerment of patients through reporting and participation;
  • increased levels of transparency and better communication.

The legislation impacts on marketing-authorisation applicants and holders. It aims to:

  • make their roles and responsibilities clear;
  • minimise duplication of effort;
  • free up resources by rationalising and simplifying reporting on safety issues;
  • establish a clear legal framework for post-authorisation monitoring

What is considered an adverse event?

It is a common misconception that adverse events and side effects are the same thing. An adverse event is an undesired occurrence that results from taking a medication correctly while ide effect is an undesired effect that occurs when the medication is administered regardless of the dose. Unlike adverse events, side effects are mostly foreseen by the physician and the patient is told to be aware of the effects that could happen while on the therapy.

There are two types of adverse events:

  • Type A – These are predictable adverse events which are commonly dose dependent and can be mild, moderate, or severe.
  • Type B – There reactions are completely unpredictable and have nothing to do with doses. They occur less often and are influenced by patient-specific susceptibility factors such as drug allergies and intolerances.

Due to the current European legislation, all adverse events detected in marketed drugs should be reported within the next 24 hours to the corresponding PV organization. Quick reaction is extremely important when these advert events result on death, life-threatening situations, hospitalisation, disability or permanent damage, congenital anomaly and/or birth defect, required intervention to prevent impairment or damage and any other serious important medical events.

The role of the European Medicines Agency (EMA) and the Pharmacovigilance Risk Assessment Committee (PRAC)

EMA coordinates pharmacovigilance in the EU and operates services and processes in line with EU legislation.

The EMA’s committee responsible or assessing and monitoring the safety of human medicines is called Pharmacovigilance Risk Assessment Committee (PRAC). It is made up of experts in medicines safety from regulatory authorities in Member States, plus scientific experts and representatives of patients and healthcare professionals nominated by the European Commission.

EMA supports the PRAC by providing data from clinical practice available in electronic health records or prescription databases.

The PRAC is responsible for assessing all aspects of risk management of human medicines, including:

  • the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account;
  • design and evaluation of post-authorisation safety studies;
  • pharmacovigilance audit.

The PRAC provides recommendations on questions on pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the:

  • Committee for Medicinal Products for Human Use (CHMP) for centrally authorised medicines and referral procedures;
  • Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) on the use of a medicine in Member States;
  • the EMA secretariat, Management Board and European Commission, as applicable.

How the EMA monitors suspected adverse events?

The Agency is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA).

EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice and clinical trials. It is used by Member states, the Agency and industry.

The PRAC evaluates safety signals from EudraVigilance and may recommend regulatory action as a result. For more information, see Signal management.

EMA publishes data from EudraVigilance in the European database of suspected adverse drug reaction reports.

Users can view the total number of individual suspected side effect reports submitted to EudraVigilance for each centrally authorised medicine.

Reports for drug substances used in nationally authorised medicines are also available since October 2014.


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