Spain was in 2014 the fourth state of the EU in authorization of new medicines

USPA NEWS - Spain was last year's fourth EU country in number of new approved drugs, a total of 1,224 products for human use. This is stated in the annual report of the Spanish Agency for Medicines and Health Products (AEMPS its acronym in Spanish) for that period, which was made public this Friday.

In memory intense activity carried out is observed, with an increase of 33% in authorizations compassionate use investigational drugs over the previous year, with over 16,000 licenses in 2014; authorizing the importation of unauthorized Spain, with more than 4,000 import authorizations in 2014, or resolution medicines, within control activities market, supply problems, getting solve 90% of cases through actions such as the issuance of special permits manufacturing or marketing when the same drug is approved in another country or providing similar drugs and foreign medicines.

Also, and to facilitate patient access to medicines under equal conditions, the Competent Authority in 2014 made an important effort in the development of 40 reports of therapeutic positioning. Another fundamental pillar governing the activity of the Competent Authority is the fight against illegal activities that threaten the health of citizens. In 2014 they had a special role the actions taken against the illegal activities of reverse distribution and the fight against illegal drug sales on the Internet.

Reverse illegal distribution activities cause serious harm to patients by depriving them of drugs resulting from this activity are unavailable in Spain and the illegal sale of medicines over the Internet poses a danger to public health. In 2014, they increased, compared to 2013, 55% performances on websites selling drugs illegally. Last year, the Competent Authority authorized 1,224 medicines for human use, with a higher resolution capability of new drug applications, which has allowed expedite response times. By type of drug, 65% of new authorizations correspond to generic drugs. Thus, at the end of 2014, in Spain there were nearly 16,000 drugs approved in nearly of 29,000 presentations and formats.

In 2014, the Spanish Pharmacovigilance System for Medicinal Products for Human Use received 17,182 reports of suspected adverse reactions. The Competent Authority in 2014 authorized the marketing of veterinary drugs 199, with an overwhelming majority by European procedures, which represents a breakthrough for the domestic industry seeks to internationalize the sector. In 2014, the Spanish Pharmacovigilance System for Veterinary Drugs received 1,148 reports of suspected adverse reaction and periodic safety update (IPS) reports 1,701 were evaluated.