Institution identification

Institution ID

3331474

Institution full name and acronym

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Institution countries

Spain

Type of institution

EU Institution/Body/Agency
Not-for-profit
Regulatory Authority

Institution role

Other

Institution website

ENCePP partner

Yes
Institution description
The Spanish Agency for Medicine and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios or AEMPS) is the regulatory agency of the Spanish administration that oversees the quality, safety, efficacy and correct information of medicines and medical devices in Spain, as well as cosmetics, from their research to their use, in the interests of the protection and promotion of human health, animal health and the environment.
The AEMPS is committed to research, development and innovation; for that purpose, it sponsors and also participates in a number of national and international research programs and projects. Among them, BIFAP (Base de Datos para la Investigación Farmacoepidemiológica en el Ámbito Público) is a nonprofit program administered and fully financed by the AEMPS that started in 2001 when primary care Electronic Medical Records (EMRs) were fully implemented throughout Spain (http://bifap.aemps.es).
The AEMPS also is the coordinating centre for the Spontaneous Reporting Scheme in Spain and also administer the database supporting this program (FEDRA).
The main use of BIFAP is to serve as a real-world data source for independent research projects to study adverse and beneficial effects and utilization patterns of medicines in the general population.
BIFAP and FEDRA are managed by the Pharmacoepidemiology and Pharmacovigilance Division in the Department of Medicines for human use of the AEMPS.
Institution details
Experience with collecting data directly from individual patients or respondents:
No
Interest in carrying out research that is funded by pharmaceutical companies:
No

Contact

Studies conducted by the institution

ACCESS template protocol for safety of COVID-19 vaccines
ADEPT: feasibility of estimating the risk of adverse pregnancy, neonatal and child outcomes following either in utero ASM exposure through the mother, or peri-conceptional ASM exposure through the father
ADEPT: The utilisation of antiseizure medications in pregnant women, other women of childbearing potential, and men: a multi-database study from 7 European countries
Background rates of Adverse Events of Special Interest for monitoring COVID-19 vaccines (ACCESS-BGR)
Calcium channel blocker treatments and cancer risk. A methodological protocol to compare the results between databases, across designs: Evaluation of the impact of design/database/population differences on the outcome of the studied association
Changes in alternative treatments for pain and cough in children after introduction of risk minimisation measures for codeine (Alternatives to codeine)
Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU
Cohort monitoring of Adverse Events of Special Interest and COVID-19 diagnoses prior to and after COVID-19 vaccination (ECVM)
Comparative effectiveness and safety studies using the target trial emulation and estimand frameworks (TARGET-EU)
Effectiveness of heterologous and booster Covid-19 vaccination in 5 European countries, using a cohort approach in children and adults with a full primary Covid-19 vaccination regimen (Covid Vaccines Effectiveness (CoVE))
Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2)
Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends
Metamizole and risk of agranulocytosis
Rapid Safety Assessment of SARS-CoV-2 vaccines in EU Member States using electronic health care datasources (CVM Covid19-Vaccine-Monitor-EHR)
Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of COVID-19 vaccines in Spain)
Risk of thromboembolic events and thrombocytopenia after vaccination against COVID-19 (Thrombosis risk COVID-19 vaccination)
SAFETY-VAC: Background incidence estimation of flares of pre-existing chronic diseases using pan-European electronic healthcare data sources. (SAFETY VAC)
SAFETY-VAC: Network of Data Sources for Vaccine Safety Evaluation
SAFETY-VAC: Phenotype proposal and rates of immunocompromised populations in real-world data sources.
Strengthening Use of Real-World Data in Medicines Development: Metadata for Data Discoverability and Study Replicability (MINERVA)
Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children (benefit study on pertussis vaccination)
The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
Use of antiepileptics and risk of suicidality. An exploratory study using the UK General Practice Research Database (GPRD) and data from the Danish registries with an evaluation of available data from further European data sources.
Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
USE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY (SRAA-COVID19)
Use of inhaled long acting beta2 adrenoceptor agonists and the risk for Acute Myocardial Infarction (AMI). A methodological comparison across data sources and epidemiological design