EMA

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.

PRAC recommends suspending use of Protelos/Osseor

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that Protelos/Osseor should no longer be used to treat osteoporosis. In April 2013 the Agency had recommended restricting the use of Protelos/Osseor to reduce the risk of heart problems. These recommendations were the result of a routine benefit-risk assessment and it was also decided at the time that there was a need for a further in-depth review.

EMA and US FDA release first conclusions of parallel assessment of quality-by-design applications

The European Medicines Agency (EMA) and the United States Food and Drug Administration (US FDA) have published a joint question-and-answer document that outlines the conclusions of their first parallel assessment of quality-by-design (QbD) elements of marketing-authorisation applications. Quality-by-design is a science- and risk-based approach to pharmaceutical development and manufacturing that was introduced a few years ago in international guidelines intended for the pharmaceutical industry. QbD involves the use of statistical, analytical and risk-assessment methods to design and develop pharmaceutical compounds and manufacturing processes to ensure the quality of the manufactured product.

European Medicines Agency creates Healthcare Professionals' Working Party

The European Medicines Agency has established a formal Healthcare Professionals’ Working Party (HCPWP) to further involve this group of stakeholders in its range of activities. The role of the HCPWP is to provide recommendations to the Agency on all matters of interest to healthcare professionals in relation to medicines. The creation of this working party represents the formalisation of the current Committee for Medicinal Products for Human Use (CHMP) working group with healthcare professionals and is a key element of the Agency's formal framework for interaction with this group of stakeholders. A similar framework is in place with patients and consumers through the Patients' and Consumers' Working Party.

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