Latest update: May 04, 2023
Spanish Regulation
| Web publication | Document title |
|---|---|
| 4/12/2015 | Royal Decree 1090/2015, regulating clinical trials with medicinal products, Ethics Committees for Investigation with medicinal products and the Spanish Clinical Studies Registry – English version |
| 25/07/2015 | Royal Legislative Decree 1/2015, of 24 July, which enacted the consolidated text of the Law on guarantees and rational use of medicinal products and medical devices. (Available only in Spanish) |
| 08/07/2010 | Royal Decree 824/2010, of 25 June, regulating pharmaceutical laboratories, manufacturers of active ingredients for pharmaceutical use and foreign trade in medicines and medicines under investigation. (Available only in Spanish) |
European Regulation
| Web publication | Document title |
|---|---|
| 27/05/2014 | Regulation (EU) nº 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use |
| 15/12/2016 | Good Clinical Practice. English version – Spanish version. |
| 24/03/2017 | Commission Implementing Regulation (EU) 2017/556 of 24 March 2017 on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council |
| 23/05/2017 | Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials) |
| 7/06/2022 | Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials |
Guidelines
| Web publication | Document title |
|---|---|
| 27/06/2023 | CTIS Guidance for Sponsors |
| 27/11/2023 | Instruction document of the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain. Spanish version – English version |
| 27/06/2023 | Access to annexes to Instruction document of the Spanish Agency of Medicines and Medical Devices for conducting clinical trials in Spain. Spanish version – English version |
| 21/06/2016 | Memorandum on Collaboration and Exchange of Information between the Spanish Agency of Medicinal Products and Medical Devices and Ethics Committees for investigation with medicinal products. Spanish version – English version |
| 27/04/2023 | Memorandum on Collaboration and Exchange of Information between AEMPS and CEIm – Trials under Regulation Spanish Version (Available only in Spanish) |
| 2/11/2022 | Common specific criteria for the accreditation, inspection and renovation of Ethics Committees accreditations. (Available only in Spanish) |
| 10/02/2015 | Circular 1/2015 on foreign trade (Available only in Spanish) |
| 05/09/2018 |
Guideline for a letter of appreciation for a clinical trial participant. (Available only in Spanish). Example of a letter of appreciation for a clinical trial participant. (Available only in Spanish). |
