Spanish standards regarding clinical trials with drug products

Spanish regulations on clinical trials with drugs are contained in laws, royal decrees, orders and resolutions.

Laws

• Legislative Royal Decree 1/2015, of 24 July: This law approves the consolidated text of the Law on Guarantees and Rational Use of Medicinal Products and Medical Devices, since it is essential that our National Health System assure health professionals that any information, training and commercial advertising of medications have scientific rigor, transparency and ethics as the central elements of their development in the practice of these activities.

Royal Decrees

• Royal Decree 1090/2015, of 4 December: Clinical research with medicinal products constitutes the basic element allowing medications to be authorized by agencies of medicinal products, be marketed by their holders with the guarantees that the legislation requires, and finally reach the clinical practice for the benefit of patients. It also allows to investigate new or more efficient ways of use of the drugs after they have already been marketed. For that reason, clinical research must be carried out in a setting that ensures the protection of its participants and in accordance with with documents such as the Declaration of Helsinki, approved by the World Medical Association, and the Agreement of the Council of Europe for the protection of human rights and dignity of the human being regarding the applications in biology and medicine, signed in Oviedo. Likewise, it must guarantee the basic principles included in Law 41/2002, of 14 November, which regulates patient autonomy, rights and obligations regarding clinical information and documentation, and in Law 26/2011, of 1 August, about regulatory adaptation to the International Convention on the Rights of Persons with Disabilities. Finally, it must also ensure that the results obtained are high quality and useful for the purposes stated before, so it must be carried out in a context of maximum transparency.
• Instructions document to conduct clinical trials in Spain: This document presents instructions from the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) to conduct clinical trials in Spain and provides information in Q&A format on the practical aspects entailed in the application of the new Royal Decree 1090/2015, of 4 December, highlighting changes with respect to the royal decree already approved Royal Decree 223/2004, of 6 February. This intends to cover any aspects that are not included in the new royal decree, as well as any other issues requiring clarification. These instructions complement the «cooperration memorandum» between the AEMPS and the Medical Research and Ethics Committees (MRECs) that summarizes the agreements between the AEMPS, as competent authority, and the MRECs to comply with Article 18 of Royal Decree 1090/2015 and establish an effective collaboration and communication between them.
• Royal Decree 824/2010, of 25 June: This Royal Decree regulates pharmaceutical laboratories, manufacturers of active ingredients for pharmaceutical use and foreign trade of medications and investigational medicinal products. The authorization by drug manufacturers and importers is of great importance with respect to the quality assurance requirements. That is why, European regulations establish specific requirements that are verified by the authorities of the Member States, as well as a system for sharing information about issued authorizations. For all those reasons, the national definition is consistent with the European legislation.

Orders

• Order SCO/362/2008, of 4 February: This order establishes detailed principles and guidelines of good clinical practices and requirements to authorize the manufacture or import of investigational medicinal products for human use.

Resolutions

• Resolution of 16 October 2009: This resolution by the Under Secretariat of the Ministry of Health and Social Policy authorizes the submission of certain documents, communications and applications related with clinical trials with drugs through the electronic registry of the Department of Health that are addressed to Medical Research and Ethics Committees or the AEMPS. Some procedures included in this resolution are: (1) authorization for a clinical trial with drugs for human use; (2) authorization for relevant modification of an authorized clinical trial; and (3) authorization for import of a drug for a clinical trial.