Initiatives in Portugal

• INFARMED, IP webpage dedicated area
• National Ethics Committee for Clinical Research (CEIC) webpage dedicated area

National scientific advice is available through the Regulatory and Scientific Advice Office (GARC). 

GARC is responsible for clarifying issues arising from the preparation of documents relating to clinical trials. Advice can be sought during initial development stages of medicinal products. For medicines, a duly justified request for fee reduction expressed in the submission form may be granted on grounds of interest for public health and company status, subject to management approval.

• Email contact for general or specific questions on submissions of clinical trial applications: ensaios [dot] clinicosinfarmed [dot] pt (ensaios[dot]clinicos[at]infarmed[dot]pt)
• Email contact for general or specific questions of clinical trials regarding ethics: ceicceic [dot] pt (ceic[at]ceic[dot]pt)

Academic clinical trials can benefit from a fee waiver if the sponsor is a non-profit institution per their legal statute or if the clinical trial does not have commercial interests.

Ordenance n.º 63/2015, de 5 de março

The Agency for Clinical Research and Biomedical Innovation (AICIB) has the mission to promote, coordinate and support activities in the areas of clinical and translational research (CI&T) and biomedical innovation, contributing to the optimisation of Portugal’s clinical, scientific and technological potential, with the objective of streamlining R&D activities and cooperation between health care units, other health institutions (DGS, IPS, ACSS, SPMS, INSA, among others), scientific and academic institutions, and the various stakeholders involved in the process.

The aim is to synergistically stimulate their potential, increasing value for society, patients, the health system and the training of health professionals in IC&T, and also to promote a scientific culture and the creation of economic value in the area of health, ensuring its sustainability and the adoption of best practices established nationally and internationally.