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EU Pharmacovigilance Legislation: An Overview

  • Susan Murphy

As described by the WHO, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and elimination of effects and other medicine related problems. Adverse effects are whereby medicines affect the body within an unintended and harmful way.

Following on from this, the underlying aims of EU pharmacovigilance legislation are to:

  • prevent harm from effects in humans arising from the use of authorised medicinal products
  • promote the effective and safe use of therapeutic products, in particular through providing timely information about the protection of medicinal products to patients, healthcare experts and the public.

Pharmacovigilance is therefore an activity adding to the protection of both patients and general public health [1].

When a new treatments obtains marketing authorization (MA), the lively element has been tested and it's been concluded that the benefits associated with this new medicine outweigh the risks. There is a limited amount of information available after professional medical trials so the decision to give MA is effectively a trade off between making a new medicine available as soon as possible and ready until as much as possible is know about the treatments.

For screening, several hundreds or a large number of carefully chosen patients will have participated in scientific trials. These trials happen under controlled conditions. However, once MA has been obtained, the treatments will now be used in normal medical settings where there will be many patients who varies from those used in the population study (eg years difference, may be using other drugs, have disease relationships. and also you will see longer term effects of using the new drugs).

So it is imperative to identify these new or changing risks as quickly as possible to take options to minimize the potential risks to patients. [2]

For company's there is a legal obligation to continuously acquire data and conduct pharmacovigilance regarding any possible change to the risk-benefit balance of taking such a treatments. In this regard, pharmacovigilance regulation seeks to protect the public from emerging safety issues by monitoring the merchandise throughout its life-time such that it is safe and effective to make use of.

The 2012 EU Pharmacovigilance Legislation [3]

New legislation regarding pharmacovigilance arrived to result in July 2012. This was the biggest change to the regulation of human drugs since 1995.

Based on facts that adverse medicine reactions brought on approx 197, 000 fatalities per year in the EU, the EC started a review of the Western european system of safeness monitoring (an independent study with intensive public discussion)

This led to a 2010 directive and legislation,

  • Directive 2010/84/EU
  • Regulation (EU) No 1235/2012

which amended the prevailing pharmacovigilance laws 2001/83/EC and regulation (EC) No. 726/2004.

This was accompanied by the implementation rules publicized in June 2012 which provided operational aspects for the new legislation (no 520/2012 19th June 2012)

A further amendment was completed in Oct 2012 following a overview of the withdrawal of the treatments 'Mediator (benfluorex)' a diabetes medication with a coronary side effect, where it was noticed that the chance now outweighed the limited advantage.

The amendments aimed to further protect the patient's health by allowing prompt notification and analysis of patient issues.

The goal of the legislation was to reduce the number of Adverse Drug reactions via

  • Collecting data on the effects of confirmed medicine from a wider 'net'
  • Rapid and powerful analysis of issues
  • Effective regulatory action to provide effective and safe use of medicines
  • Better patient engagement through opinions and reporting
  • More transparency on the effects and basic safety of medicines concerned

For MA people and holders the new legislation would:

  • Makes their assignments and obligations clear
  • Minimize duplication of effort
  • Free up resources by rationalizing and simplifying reporting on safeness issues
  • Clear legal construction for post authorisation modifying

In short, the key goal of the legislation was to lessen the human and financial cost burden of adverse medicine reactions, to reinforce patient involvement in monitoring medicines and also to make the public strongly aware of the risk-benefit characteristics of taking drugs.

New Concepts unveiled in the 2012 Pharmacovigilance Legislation

The concept of additional monitoring and the black symbol were launched by the new European union laws and regulations on the safety-monitoring of drugs, (called the pharmacovigilance legislation, ) which began to come into impact in 2012.

Any new remedies authorised after 1 September 2013 that is at the mercy of additional monitoring must display the black mark in the bundle leaflet and the conclusion of product characteristics when it is located on the European union market. Also any educational materials relating to this medicine should suggest its additional monitoring position.

The legislation affects medicines authorised in the European union after 1 January 2011. For this reason, a move period for medicines authorised between January 2011 and August 2013 was allowed whilst companies their kept up to date packaging and gradually phased in the new leaflets.

Medicines under additional monitoring [4]

This is a fresh process to label medications that are being watched closely by the regulatory regulators. A solid dark-colored ugly triangle shown on the package leaflet and information for medical care professionals signifies that the drugs is considering additional monitoring. The sign started to appear in later 2013.

A remedies may be subject to additional monitoring because

  • Not just as much data is obtainable with this medicine
  • Less information is available on the long-term impact of by using this medicine
  • Does not imply that the medication is unsafe.

This label is now always requested:

  • Any new API authorized after Jan 2011
  • Any biological drugs authorized after Jan 2011
  • For medications authorised under exceptional circumstances
  • If there are uncommon side effects seen through the trial or permanent usage results which warrant more info gathering.

A medicine subject to such monitoring, can stick to the 'Drugs at the mercy of additional monitoring ' list printed by the EMA for 5 years.

Why are medicines monitored after acceptance?

Marketing acceptance is granted to medicines based on medical trial results.

These consist of a small quantity of patients trialled under handled conditions over a comparatively short period of the time. In true to life, however a more diverse group of people will use the drugs and there could be different interactions in addition to the effects of longer term use. To have any rare or long term side effects which might then come to light into consideration, it is essential to continue to screen the safety of all medicines whilst they are simply in commercial use.

Information is continually collected after having a medicine is positioned on the marketplace to screen real-life experience with the product. European regulatory specialists closely monitor these details to make sure that the benefits of medicines continue steadily to outweigh their hazards.

Standardised monitoring methods are being used across the European union so that information can be effectively distributed by the member says regulatory authorities. This provides an abundance of knowledge for regulators to rely upon when coming up with decisions, and permits an instant response when required, such as providing warnings about the remedies or restricting its usage.

Reporting area effects

Reporting suspected area effects can be an important way to assemble more info on medicines on the market. Regulatory authorities look at reports of part effects alongside everything they already have to ensure that the benefits of medicines remain greater than their risks and also to take any necessary action.

Patients and health care professionals should record suspected side effects seen with any remedies. Under the new pharmacovigilance legislation, patients hold the right to survey suspected side results right to the national medicines regulatory authorities in their country if they wish. The onus is on the business to provide information how to get this done on their package deal leaflet.

The black triangle can help you quickly identify drugs that are subject to additional monitoring, stimulating customers to feed back again any adverse effects. This allows new data to be analysed in a rapid and robust manner. [5]

Update on aftereffect of 2012 Pharmacovigilance Legislation

A report released in 2014 summarised the key effects of bringing out the new legislation [6]. The most known of these were (during the reporting period 2012-2013)

- Adverse Medicine response reporting has increased by

> 175, 000 more individual case safe practices reports

> 9, 000 more patient reports

- Label Changes from more that 47% of signals reported

- By August 2013 119 medications were shown under additional monitoring list.

- Major general public health reviews have been initiated on put together hormonal contraceptives, codeine-containing products and tetrazepam to mention but a few.

- Better information is currently available via the agencys website for therapeutic decision making


The goal of the Pharmacovigilance legislation is to enhance patient attention and safety with regard to medicines also to support open public health programs by providing well-balanced reliable information.

Real life use of drugs only happens once pros begin to recommend or dispense. It really is vital that the security of all medicines is watched throughout their life-time.

Adverse drug reactions account for 5% of all clinic admissions and are the 5th most common cause of medical center death.

For EU people, the purpose of the new pharmacovigilance legislation is to

  • Strengthen patient participation in the monitoring of drugs. This allows for continuous reviews on the effects of taking medications through its lifecyle and therefore rapid and robust examination of issues.
  • Reduce the burden of ADRs
  • Inform and participate citizens on the risk/gain aspect of taking medicines.

Full implementation is expected to save between 500 and 5000 lives yearly with an expense saving to modern culture of between 250million and 2. 5billion per time [7].

There is concrete evidence that the new legislation is causing changes that will lead to improvement in public health. This is demonstrated by greater quality on the tasks and obligations for the get-togethers involved with pharmacovigilance (MA applicants and holders, EMA, EU and member express regulatory authorities) and also higher transparency on medication safety for the patient. This serves to raise the understanding and trust of both patients and healthcare employees on the effective and safe use of medicines in the European union[6].


[1] http://www. ema. europa. eu/docs/en_GB/document_library/Other/2014/09/WC500172403. pdf

[2] EMA 'Pharmacoviglience' 2013 23/03/2013 NC50010423. pdf

[3]http://www. ema. europa. eu/ema/index. jsp?curl=pages/special_topics/general/general_content_000491. jsp&mid=WC0b01ac058058f32d

[4]http://www. ema. europa. eu/docs/en_GB/document_library/Other/2013/04/WC500142430. pdf

[5]http://www. ema. europa. eu (Medicines under additional monitoring)

[6] http://ec. europa. european union/health/files/pharmacovigilance/2014_ema_oneyear_pharmacov_en. pdf

[7] http://www. ema. europa. eu/docs/en_GB/document_library/Presentation/2013/01/WC500137839. pdf

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