a total of 125 pages on the Internet were investigated and processed a total of 73 records
MADRID, 2 ( EUROPA PRESS)
Spanish Agency of medicines and Health products ( AEMPS) authorized last year the marketing of 1,934 medicinal products for human use, which meant a 40 per cent more than in 2010; 77 percent of these authorisations corresponds to generic drugs, according to collect his memory 2011 published this Monday, and where it is evident he has seen increased activity in all areas.
Thus emphasizes that in the area of pharmacovigilance, in 2011 received and assessed 14.886 notifications of suspected adverse drugs reactions; while in the chapter of illegal and counterfeit medications, they referred to the Agency 3.936 samples, 93 percent more than the previous year.
In addition, authorized 748 clinical trials and 160 in research phase with medicinal products for human use, and 19 clinical trials and 8 products in veterinary medicinal products research phase. Also authorized 25 clinical research with medical devices.
This memory, explained from the Ministry of health, social services and equality, insight into key indicators that allow to know the evolution of their activity as well as the projects and advances outstanding over the last year, in which there has been a notable increase of its efficiency in management.
“The AEMPS has developed in 2011 an intense work to allow citizens to have medicines for human and veterinary use, medical devices, cosmetics and personal hygiene with all the guarantees required.” “All areas have increased their activity and efficiency,” added.
93% More samples to analyze
In the field of inspection and control of drugs during the year 2011 has maintained the high number of inspections carried out. In particular, include the high percentage of international, 12 per cent of the total, mostly at the request of the European Medicines Agency (EMA, by its acronym in English).
As regards the proceedings on illegal and counterfeit, drugs in 2011 remained the upward trend in all proceedings. It should be noted the significant increase in number of samples sent by the courts and bodies and security forces of the State, which in 2011 arrived at the figure of 3.936 samples (93% more than in the year 2010).
In 2011 also significantly increased the number of drugs that have been issued reports on the risks posed to health illegal use and increased activity on the illegal sale of drugs via the Internet. A total of 125 pages have been investigated and processed a total of 73 records.
Drugs, cosmetics and veterinary
In addition to the “soaring” authorisations of medicinal products for human use, the Agency highlights the increase in resolution of variations in the authorisation of these medicines. Shorter-range variations or variations type I, with 21.338 resolved variations (122% more than in 2010), both in the type II, those having impact on the quality, safety or efficacy of the medicinal product, with 7.111 resolved variations (33% more in 2010).
On pharmacovigilance, it should be noted that the system Spanish for pharmacovigilance of medicinal products for human use received 14.886 notifications of suspected adverse reaction.
In the area of veterinary medicinal products have been authorized the marketing of 136 veterinary medicinal products, with a marked increase in the resolution of authorisation variations minor or type I 1.888 resolved variations (250% more than in the year 2010) and major variations or type II, with resolute 435.
On the activity of veterinary pharmacovigilance, in 2011 has been launched the Technical Committee of the Spanish system of veterinary pharmacovigilance. There were a total of 424 notifications of adverse effects in Spain and 1,136 newspapers reports of security (IPSs). What is concerning the notification of quality defects, 19 notifications, which led to three alerts for these reasons were handled.
In the field of medical devices, the AEMPS, granted the CE mark of conformity to 213 products (486 variants of marketing) and extended the EC certificates to 121 products (337 variants of marketing), making 119 audits of quality manufacturers.
As for the performances for surveillance of these products, recorded a significant increase compared to previous years, with 2,378 notifications received during the years 2011 and 638 broadcast alerts (16%. than in the year 2010). Also recorded a significant increase the activity of market control in the detection of medical devices not compliant and illegal.
In the area of cosmetics and products of personal hygiene, the largest increase of activities has taken place in the control of the market with 1,988 performances (32% more than in 2010) and the issuance of certificates for export (1,728 certificates).
. In the field of cosmetics and personal hygiene products are authorized 96 products of personal hygiene and 197 modifications of authorised products and registered 25.713 information for the purposes of medical treatment (IETMS) cosmetics. In cosmetics 19 adverse effects were investigated and were transmitted to the autonomous communities 145 European alerts.
Leadership in the European network of agencies
The AEMPS collects in his memory his intervention in the evaluations and inspections that are coordinated from the European Medicines Agency and stresses the fifth place in the same as Rapporteur on procedures for medicinal products for human use centralized type; fourth place as reference Member State on European procedures of authorization of mutual recognition and decentralized of veterinary medicinal products or the fact of being one of the first agencies in number of international inspections of standards of good clinical practice.
In the field of international cooperation, the AEMPS maintains a permanent line of cooperation with Latin America, through authorities Competentes in medicines of the Iberoamerican countries (EAMI) meetings. In 2011, the implementation of the Regional system of pharmacovigilance in Central America and Dominican Republic was pushed.
On the other hand, highlights the activity of its a new web ' www.aemps.gob.es ' filed last year with the aim of improving access of citizens and professionals to the information of the products it regulates and the actions carried out on the same.
Indicators of the role of the Agency in this regard have been the more than 4 million visitors, more than 8 million documents of data sheets and brochures with information on medications downloaded by citizens, or the more than 200 briefing notes and published on the web alerts, all of this through the year 2011.
