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Pharmaceutical Technology Europe

Pharmaceutical Technology Europe, Pharmaceutical Technology Europe-08-01-2012, Volume 24, Issue 8

Pharmacovigilance rules enter into effect.

Monday 2 July saw the implementation of Europe's pharmacovigilance legislation, which comprises Regulation (EU) No 1235/2010 and Directive 2010/84/EU. In line with the new legislation, EMA has released a series of modules that together will form guidance on good pharmacovigilance practices (GVP). Each module will cover one major process in the safety monitoring of medicines.

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Seven modules have been finalised so far and another two are open for public consultation until 24 August 2012. The guidance is expected to comprise 16 modules in total, with the remaining ones to be released later this year, and will apply to marketing-authorisation holders, as well as to EMA and other regulatory authorities in the EU.

Finalised guidelines

The seven finalised modules cover the core processes of the new pharmacovigilance legislation that needed to be published for the 2-July implementation deadline. They are:

  • Module I: Pharmacovigilance systems and their quality systems

  • Module II: Pharmacovigilance systems master files

  • Module V: Risk management systems

  • Module VI: Management and reporting of adverse reactions to medicinal products

  • Module VII: Periodic safety update reports

  • Module VIII: Post-authorisation safety studies

  • Module IX: Signal management.

  • All of the modules were open for consultation earlier this year and the received comments have been incorporated into the final versions.

Guidelines for consultation

At the end of June, EMA also released Module III on pharmacovigilance inspections and Module X on additional monitoring for public consultation.

Module III provides guidance on planning, conducting, reporting and following up on pharmacovigilance inspections in the EU. The objectives of the inspections will be to determine that the marketing authorisation holder has appropriate personnel, systems and facilities in place to meet pharmacovigilance obligations. Inspection results will be used as a basis for enforcement action (if necessary) and information on the conduct, outcome and follow-up evaluation will be made publicly available as part of the overall transparency of pharmacovigilance activities.

The aim of Module X is to rapidly detect and respond to any potential safety hazards associated with the use of medicinal products by collecting additional information as early as possible. The module is divided into two sections; one providing general principles for assigning additional monitoring status; and the second describing the operation of the EU network regarding supervision of monitoring status.

The big change

According to EMA, the pharmacovigilance legislation is the biggest change to the regulation of human medicines in the EU since 1995 and will establish a clear legal framework for postauthorisation monitoring. In addition, EMA hopes the legislation will make roles and responsibilities clear, minimise duplication of effort and free up resources by rationalising and simplifying adverse drug reaction reporting and periodic safety update reporting.

In June, the European Commission also published Regulation (EU) 520/2012 in the Official Journal of the European Union. The regulation complements the 2010 pharmacovigilance legislation by providing more technical details that will need to be observed by marketing authorisation holders, EMA and national authorities in day-to-day application of the new legislation.

News bites

Investigation at Roche

The EMA has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

GSK Pleads Guilty

GlaxoSmithKline has agreed to plead guilty and pay $3 billion (2.4 billion Euros) to resolve criminal and civil liability resulting from the unlawful promotion of certain drugs, failure to report safety data and alleged false price reporting practices. According to the Justice Department, it is the largest healthcare fraud settlement in US history.

US Healthcare Reform

The US Supreme Court has upheld the provision of the country's Affordable Care Act. Among other points, the decision means that FDA can continue to implement the new biosimilars programme. Implementation of US reform now depends on who controls the White House and Congress after the elections, as well as individual states implementing the law.

Merck Restructuring

Merck Serono has revealed its "final efficiency program" for operations in Switzerland, which includes confirmation of the closure of sites in Geneva and Coinsins. The majority of job transfers and cuts are expected to be completed later this year. Closure of the Geneva site is planned for mid-2013 and for 2014 for the Coinsins site.