CHMP reflection paper stresses need to make benefit risk data more explicit
As the European pharmaceutical industry expresses concerns that regulatory bodies are focusing increasingly on risk avoidance rather than benefit-risk assessment, the European Medicines Agency (EMEA) has made a concerted effort to set the record straight. The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has now submitted a reflection paper aimed at providing recommendations on ways to improve the methodology, consistency, transparency, and communication of its own benefit-risk assessment activities.

EFSA deems 120 nutrient sources dossiers as incomplete for safety assessment
During a safety assessment process for nutrient sources used in food supplements, the European Food Safety Authority (EFSA) has considered 120 dossiers submitted by operators as “not adequate” for further scientific assessment. In a statement adopted at its April meeting, the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC) concluded that the safe use of these nutrient sources – the list of which has been provided in the statement itself – and the bioavailability of the nutrients from these substances cannot be assessed due to limited information provided in these problematic dossiers.

Norway inclusion on US patent black list inflames pharma industry
The US has placed Norway on a watchlist of countries where patent protection is deemed to be inadequate, much to the consternation of the Norwegian pharmaceutical industry. Pal Christian Roland, Director General of the pharmaceutical industry association, LMI, says that the situation is nothing short of "an embarrassment”. Last year, the office of the US Trade Representative (USTR) already announced that it planned to include Norway on the watchlist for 2008, because it was concerned about the lack of product patent protection for certain pharmaceuticals.