The European Medicines Agency has started publishing information on ongoing applications for extensions of indication of human medicines today in the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC). The new level of transparency involves the publication of information on applications for changes to the authorised use of medicines where a change to the risk-management plan (RMP) is needed. In these cases, the PRAC is required to provide advice to the Committee for Medicinal Products for Human Use (CHMP) on the necessary updates to the RMP. The CHMP is the committee that is responsible for making a recommendation to the European Commission on whether to grant the extension applied for or not.
The minutes from the PRAC's meeting of 1-3 October 2012, published today, include information on applications for extensions of the indications for the medicines Simponi, Onglyza and Komboglyze.
The publication of information on these types of ongoing application in PRAC minutes is outlined in the countdown to July 2012: the establishment and functioning of the PRAC, published in July this year.
The PRAC has been publishing agendas and minutes of its meetings since its formation in July 2012. All seven of the Agency's scientific committees, including the CHMP, will be publishing agendas and minutes systematically by the end of 2013.