This legislation was accompanied by the Implementing Regulation, a legally binding legal act published by the European Commission in June 2012 that contains details on the operational aspects of the legislation: The legislation amended the existing pharmacovigilance laws of Directive 2001/83/EC and Regulation (EC) No 726/2004. Find detailed information on the initiatives introduced by the legislation and their impact They implement pharmacovigilance legislation. Many of the challenges in monitoring drug safety stem from the limited amount of information available in clinical trials at the time a drug is authorized. Regulators need to strike a balance between making new medicines available for use in patients as quickly as possible and waiting for sufficient information on a product`s quality, safety and efficacy. Practical measures to facilitate the implementation of pharmacovigilance in accordance with the legislation are set out in the Good Pharmacovigilance Practice (GMP) Guideline. GMPs apply to marketing authorisation holders, the European Medicines Agency and medicines regulators in EU Member States and cover medicines authorised centrally through the Agency and medicinal products authorised at national level. Pharmacovigilance legislation aims to reduce the number of ADRs in the EU. The objective is to achieve this objective by: This is why the European Commission launched a review of the European safeguards system in 2005, including the promotion of an independent study and a broad public consultation in 2006 and 2007. In October 2012, pharmacovigilance legislation was further amended following a review of the withdrawal of the medicinal mediator (benfluorex). The amendments aimed to further strengthen the protection of patients` health by allowing rapid notification and assessment of safety issues: the European Medicines Agency, EU Member States and the European Commission are responsible for the implementation and functioning of much pharmacovigilance legislation. The Agency plays a key role in coordinating activities related to the authorisation and supervision of medicinal products, including guarantees, within this network. By continuing to gather information as soon as a drug is available and taking appropriate action, regulators can continue to protect the public from emerging safety issues throughout a drug`s lifecycle, ensuring its safe and effective use.
The development of pharmacovigilance legislation was based on the finding that adverse drug reactions, i.e. `unintentional` reactions to a medicine, caused around 197 000 deaths per year in the EU. However, after approval, patients taking one drug may have other illnesses and take other medications. It is also used in a larger number of patients, which increases the possibility that rare side effects will occur only after using the drug. Some side effects may not occur until a medication has been used for a long period of time. Patients participating in clinical trials are carefully selected and monitored very closely under controlled conditions. This process led to the adoption of a Directive and Regulation by the European Parliament and the Council of Ministers in December 2010, which led to significant changes in the safety of medicines across the EU: the Agency works with a wide range of stakeholders, including the European Commission, pharmaceutical companies, national medicines regulators, patients and healthcare professionals, to ensure effective implementation and enforcement of pharmacovigilance. Legislation. For detailed information on the progress made in implementing the legislation, see Implementation of pharmacovigilance legislation. The pharmacovigilance legislation, which entered into force in July 2012, was the biggest change to the regulation of medicinal products for human use in the European Union (EU) since 1995. It has had a significant impact on EU applicants and authorisation holders, as well as on patients, healthcare professionals and regulators.
