EMA

Tailored scientific advice to support step-by-step development of new biosimilars

The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine.

Better monitoring of biological medicines

The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled "Product- or population-specific considerations II: Biological medicinal products". Good pharmacovigilance practices are a set of measures designed to ensure the robustness of the system of safety monitoring. The new chapter provides guidance on how to better monitor and manage the safety of biological medicines to optimise the safe and effective use of these products in Europe.

EMA's medical literature monitoring enters into full operation

The European Medicines Agency (EMA) has started its full medical literature monitoring service on 1 September 2015. A total of 400 active substance groups (300 chemical active substance groups and 100 herbal active substance groups) will now be monitored by EMA. The service will benefit over 4,000 companies. The list of active substance groups and a reference to the journals covered by EMA’s medical literature monitoring service are available on the monitoring of medical literature page. Companies are advised to consult the list to check whether their products are covered by the service.

Europe to boost cooperation with international partners on generics

The European Union's decentralised procedure is being used as a model to accelerate the assessment of applications for generic medicines as part of the International Generic Drug Regulators Pilot(IGDRP). The European Union (EU) is leading an international pilot project through which, upon request from a generic pharmaceutical company, it will share the assessment reports generated as part of the decentralised procedure in real time with collaborating regulatory agencies outside the EU. By offering to share its assessment reports, the EU aims to reinforce collaboration and information-sharing between regulatory authorities across the world, contributing to facilitating and strengthening the scientific assessment process for medicines.

European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014

Thirty-nine medicines for human use were recommended for marketing authorisation by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012. This figure includes a number of new innovative medicines with the potential to meet unmet medical needs, treat diseases for which no treatments were previously available or bring significant added benefit to patients over existing therapies. Among these medicines are the anticancer medicines Mekinist (trametinib) and Gazyvaro (obinutuzumab), the anti-inflammatory Entyvio (vedolizumab), the anti-infective Daklinza (daclatasvir), as well as Translarna (ataluren) and Sylvant (siltuximab), which are both intended for the treatment of rare conditions.

EMA publishes 2013 annual report

The European Medicines Agency (EMA) has published today its 2013 annual report. In 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorisation, compared with 57 in 2012. The number of medicines containing a new active substance has continuously increased for the past three years, while the number of generics is stable compared with 2012 but generally decreasing over the last few years. Two new advanced-therapy medicinal products (ATMPs) were recommended for approval in 2013, bringing to four the total number of ATMPs recommended for approval by the CHMP since the legislation on advanced therapies became operational.

Committee for orphan medicines - overview of 2013 and looking ahead

A total of 11 out of 81 medicines recommended for marketing authorisation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in 2013 were intended for the treatment of rare diseases. This continues the year-on-year increase in the number of marketing authorisation recommendations for medicines for rare diseases observed over the last few years (with 8 in 2012 and 4 in 2011). One of the explanations offered by the Committee for Orphan Medicinal Products (COMP), the EMA committee responsible for recommending orphan designation of medicines for rare diseases, is that developers of orphan medicines are now making much better use of the tools offered by the Agency and the European Orphan Regulation to support them in the development of their medicines.

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