Biosimilars – A naming and labelling challenge

Blog 33 - Biosimilars-1 One of the challenges posed to regulators will be the naming requirements for biosimilars. In order for physicians to select the most appropriate biosimilar medicinal product and also for pharmacovigilance purposes, the question has been asked as to what proprietary and/or non-proprietary name should be permitted for use on biosimilar products.

RMP summaries

EMA’s further step towards transparency Most regulatory agencies that are strongly committed to promoting safe use of medicines constantly strive to communicate with the public and stakeholders in an open and transparent manner. They put in the best efforts to convey information about the medicines and their use to the consumers in an easy and comprehensible form. Increased transparency and public access to information about medicinal products are high on the agenda of the European Medicines Agency (EMA). The EMA has put in place the European Risk Management Strategy (ERMS) which focuses on proactive conduct of pharmacovigilance in the European Union (EU) and lays out measures that allow for the early detection, assessment, minimization and communication of risks of medicinal products throughout their lifecycle.

The Black Triangle Scheme

Pharmacovigilance legislation in the European Union (E.U.)

Blog23-image 3The European Union (E.U.) has adopted numerous laws in order to strengthen its position and act as a governing body for those countries under its umbrella. One such area in which this is happening is through a Regulatory scheme which has been in place in the United Kingdom for many years – ‘The Black Triangle Scheme ‘. This scheme is used to monitor the safety of New Medications and Vaccines throughout all EU member states.

The scheme focuses on medications which are being monitored particularly closely due to the fact that relatively little information is known about them outside of clinical trials; for example it may have been placed on the market only recently.

New medications to the market may have only recently finished clinical trials involving relatively small groups of selected individuals who take the medication for a relatively short period of time and may not be fully representative of the consumers who will ultimately purchase or be prescribed this medication. However, this by no means implies they are unsafe.

The Changing Face of EU Variations

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As of the 4th of August 2013 Commission Regulation (EU) No 712/2012 will be implemented into the EU, making a large number of changes as to how variations will be processed.    It has been over three years since the EU variation legislation was updated when Commission Regulation (EU) 1234/2008 came into force, changing important fundamentals concerning how variations to licences are categorised and processed.  Since January 1st 2010 national Health Authorities have been adopting this legislation into their processes for National Marketing Authorisations.   Subsequent to the collective experiences of the preceding years a number of refinements have been set in place and form the framework for this legislative update.  Perhaps the most important one of these is the mandating of all EU markets to adopt this new way of working.