EMA

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.

Croatia becomes a new member of the European medicines network

On 1 July 2013 Croatia joined the European Union. Croatia is now part of the European medicines network and its representatives will be fully involved in the activities of the seven Scientific Committees of the European Medicines Agency (EMA) as well as the Agency's other activities. Preparation for the participation of Croatia in the EMA's activities began in 2007, when the European Commission's Instrument for Pre-accession Assistance (IPA) programme for Croatia was put in place. Under the framework of the IPA, the Agency worked with the Croatian national competent authorities to prepare their participation in the EMA's activities and contribute to the creation of information-exchange systems to support its integration into the European medicines network.

Public consultation open on guideline on the acceptability of names for human medicines

The European Medicines Agency has released the sixth revision of the guideline on the acceptability of names for human medicinal products processed through the centralised procedure for public consultation. The current update of this guideline provides further recommendations on the requirements for acceptability and submission of proposed (invented) names.

European Medicines Agency issues six key recommendations to tackle the issue of medication errors

The European Medicines Agency (EMA) has issued six key recommendations to tackle the issue of medication errors causing harm in the European Union (EU). These recommendations are described in the medication-errors workshop report. This workshop was held by the Agency from 28 February to 1 March 2013 to raise awareness of this important public-health issue. The Agency, in collaboration with the European Commission and the EU regulatory network, will now develop an action plan, which it will publish before the end of the year.

European Medicines Agency simplifies processing of fee reductions for orphan medicines

The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the Agency's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions. Medicines that have been granted orphan designation by the European Commission on the recommendation of the Agency's Committee for Orphan Medicinal Products (COMP) are eligible for fee reductions for a range of regulatory activities.

Recommendation to suspend tetrazepam-containing medicines endorsed by CMDh

Following the recent recommendation by the Pharmacovigilance Risk Assessment Committee (PRAC), the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by majority the PRAC recommendation to suspend the marketing authorisations of tetrazepam-containing medicines across the European Union (EU). The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national marketing authorisation procedures across the EU.

EMA

More Pharma News ...