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EMA recently issued two draft Good Practice Guides,which are aimed at improving the reporting, evaluation, and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU.

The report details concrete proposals to encourage development and authorization of ATMPs in the EU.

EMA has begun translating its recommended changes to product information based on the assessment of safety signals into all official languages of the EU.

The EMA Pharmacovigilance Risk Assessment Committee ("PRAC") confirmed a small increase in the risk of cardiovascular problems.

On April 29, 2016, EMA adopted an opinion recommending extending the authorized indication of Gazyvaro (obinutuzumab) to treat patients with follicular lymphoma.

EMA has completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat COPD.

EMA has updated its rules on declarations of interests for scientific committee members and experts.

The summaries will include information on the herbal substance assessed, HMPC's conclusions on its recommended uses, the data supporting the recommendations, and the potential side effects associated with the use of the herbal substance.

On October 1, 2015, the EMA's Management Board nominated Guido Rasi as the executive director of the Agency.

On November 17, 2014, the EU authorized the following the health claim for use on fats and oils: "Replacing saturated fats with unsaturated fats in the diet has been shown to lower/reduce blood cholesterol.

In addition, novel foods must undergo a scientific assessment prior to authorization to ensure their safety.

On January 6, 2015, Commission Regulation 2015/7 of 6 January 2015 authorizing a health claim made on foods was issued authorizing the claim that carbohydrates contribute to the recovery of normal muscle function...

On March 31, 2015, the EU milk quota regime came to an end. Milk quotas were introduced to address the structural oversupply on the EU market of the late 1970s and early 1980s.

The proposal will be submitted to the European Parliament for a vote at first reading and to the Council for final adoption.

The members of the Committee were concerned that the proposal might prove unworkable and lead to the reintroduction of border controls between pro- and anti-GMO countries.

On March 19, 2015, the European Commission issued Commission Regulation (EU) 2015/463 of 19 March 2015, amending Annex to Regulation (EU) No 231/2012...

The European Commission ("Commission") recently published a new version of its position paper on cosmetics in the Transatlantic Trade and Investment Partnership negotiations with the United States.