[Regulation about generics approval].
OBJECTIVE
To analyze current legislation referring to generic drugs and to update knowledge concerning these drugs.


METHODS
In this paper Spanish and European regulations have been reviewed in relation to the authorisation and procedures that guarantee the quality, safety and efficacy of generics.


RESULTS
The countries belonging to the European Union have established, through the European Medicine Agency (EMEA), uniform criteria for authorisation and data exclusivity, regulated by Directive 2004/27 and Regulation 726/2004, which are being implemented in our country through Law 29/2006 of Guaranty and Rational Use of Medicines and Medical Devices.


CONCLUSIONS
Although mechanisms of price regulation and financing policy are different throughout the member States, most countries have introduced measures to reduce the increase in expenditure on medicines, with generic products being an important aspect since they are less expensive than innovating medicines.
Laguna-Goya
N
N
División de Farmacología y Evaluación Clínica, Subdirección General de Medicamentos de Uso Humano, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain. nlaguna@agemed.es
Blázquez-Pérez
A
A
Pozo-Hernández
C
C
D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016527:Drug Costs / Q000331:legislation & jurisprudence; D004341:Drug Evaluation / Q000331:legislation & jurisprudence; D016568:Drugs, Generic / Q000191:economics / Q000592:standards; D005062:European Union; D005568:Forms and Records Control; D013030:Spain; D013810:Therapeutic Equivalency
D016568:Drugs, Generic