European Medicines Agency [to 7 November 2015]
http://www.ema.europa.eu/

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:: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-5 November 2015
06/11/2015
Review concludes evidence does not support that HPV vaccines cause CRPS or POTS
The PRAC has completed a detailed scientific review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines. These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions. This review concluded that the evidence does not support a causal link between the vaccines (Cervarix, Gardasil/Silgard and Gardasil-9) and development of CRPS or POTS. Therefore there is no reason to change the way the vaccines are used or amend the current product information. More information is included in the table below.

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:: Supporting better use of medicines
06/11/2015
EMA releases guidance on methods to be used in the design and conduct of post authorisation efficacy studies
The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorisation efficacy studies (PAES) should be designed by companies to support regulatory decision making in the European Union (EU). In addition, a guidance that describes the regulatory aspects for the fulfilment of imposed PAES is also published.