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European Medicines Agency launches consultation on pharmacovigilance changes to product information

The European Medicines Agency has launched a public consultation on the changes to the product information stemming from the new pharmacovigilance legislation. The legislation requires the addition of information to the summary of product characteristics, which is targeted at healthcare professionals, and to the package leaflet, which is targeted at patients and consumers. This information includes:

European Medicines Agency encourages companies to use electronic application tools

The European Medicines Agency reminds pharmaceutical companies that electronic application formsExternal link icon are available for use. Applicants can use the online forms for all applications for human and veterinary medicines in the centralised procedure. The electronic forms offer a convenient alternative to the paper versions and include the same content with structured data fields implementing controlled terminology lists and catalogues.

New pharmacovigilance legislation comes into operation

Better protection of public health through strengthened EU system for medicines safety
The European Medicines Agency welcomes the start of new European Union (EU) legislation on pharmacovigilance. This new piece of legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.

European Medicines Agency finalises update to diabetes guideline

The European Medicines Agency has updated its guidance for pharmaceutical companies developing medicines for the treatment or prevention of diabetes. The guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus, published today, updates the previous document from 2002. It gives guidance on the clinical studies required to support the authorisation of new medicines for treating or preventing diabetes.

Revised guideline on quality of biosimilar medicines open for comments

The European Medicines Agency has released a revised guideline for public consultation describing how pharmaceutical companies should address the quality aspects of biosimilar medicines. The guideline updates the previous guidance from 2006, and explains the requirements for the manufacture and comparability testing for biological medicines claiming to be similar to another medicine already on the market.

European Medicines Agency boosts EU transparency

The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website. The reports come directly from the European Union (EU) medicines safety database EudraVigilance, and are one of the many types of data used by regulators to monitor the benefits and risks of a medicine once authorised. The launch of the new website is part of the Agency's continuing efforts to ensure EU regulatory processes are transparent and open and is a key step in the implementation of the EudraVigilance access policy.

Reflection paper on classification of advanced therapies released for public consultation

The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation. The paper clarifies the legal basis for the classification of medicines as advanced therapies and provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines. It also gives details on the types of information that applicants need to submit to the Agency when applying for classification of their medicine as an advanced therapy, and discusses of some borderline cases and areas where scientific knowledge is limited or evolving rapidly.

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