GESTO platform: Publication of results of retrospective observational studies

After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of retrospective observational studies in the spanish clinical trials registry, as we mentioned in a previous post.

Thus, the AEMPS with the aim to facilitate this process has developed the platform GESTO and has published guidelines and instructions which explain how it works.

Within 15 days after the start of the study, it will be mandatory to apply for registration on this platform, with only the favourable opinion of the ethics committee being necessary for the AEMPS to approve the application.

In addition, it is important to note that both positive and negative results should be published within 1 year from the end of the study or within 30 days of publication in a journal.

Information related to instructions and user guidelines for the GESTO platform can be found at the following links:



Procedure and technical measures in order to comply with General Data Protection Regulation 2016/679 are being more and more standardized through codes of conduct in several fields. Until now, there are not a code of conduct geared to Contract Research Organization (CRO). EUCROF has been working in a “Code of Conduct for Service Providers in Clinical Research” since 2017 and it has already been submitted for approval.

This code of conduct develops 237 requirements in order to comply with  GDPR in the 23 possible services provided by CROs detailed in the code. In order to a CRO can adhere to the code of conduct, CRO must deliver at least one service of those described and obtain the approval of a Supervisory Body called COSUP. Both, EUCROF members and non-members will be able to adhere to this code of conduct.

For more information: Code of Conduct for Service Providers in Clinical Research



Great news upcoming!

Yesterday, EMA’s Management Board confirmed that the clinical trial EU Portal and Database, is now fully functional and on track to go live by 31 January 2022.

In order to comply with the schedule, the European Commission must verify that all Clinical Trial Regulation have been met and publish the outcome in the Official Journal of the European Union on 31 July 2021. Six months after this publication, the Clinical Trial Regulation will start to apply and CTIS will go live.

When CTIS is available, it will be the single entry point for clinical trial applications in European Union. Furthermore, sponsors will be able to apply for a clinical trial in all countries of the European Economic Area (EEA) at the same time rather than to apply in every country.

More information can be found here:



Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014.

The implementation to a European level implies a Harmonization of the submission of a clinical trial from all Member States of the part I documentation: documentation to be reviewed by Health Authorities, as well as part II documentation: documentation to be reviewed by Ethics Committee. The submission will be performed to the Reporting Member State selected by the sponsor but all documentation will be evaluated by the Reporting Member State and the others involved Member States.

In order to comply with transparency principle of the regulation, a new platform called Clinical Trial Information System (CTIS) will be available to submit and publish clinical trial information and documentation. EU portal is included in this platform. All submissions will be performed through the EU portal in which will be necessary registration.

The Clinical Trials Regulation (EU) 536/2014 and all new functionalities are foreseen to become applicable at the end of January 2022.

Complete training documents are available at EC-DG SANTE/HMA-CTFG/EMA joint training on the Clinical Trials Regulation (EU) 536/2014 | Public Health (

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New regulation for observational studies with medicines for human use in Spain

Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE.

This regulation will come into force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into account the observational nature of these type of studies with drugs that are already  part of clinical practice.

From now on, the previous requirements to start the observational studies with medicines are limited to the favorable opinion of the CEIm and the agreement with the participating study sites, removing the classification by AEMPS.

In addition, in the prospective observational studies with medicines, it is possible for the Autonomous Communities to develop their own regulations based on their competences.

It is important to note that it will be mandatory to include prospective observational studies in the Spanish Clinical Trials Registry.

In the following link you can find all the information about this subject:

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. U.S. health officials unveiled plans to fight avoidable injuries from medication errors or misuse, a problem that harms hundreds of thousands of people each year and can be deadly.    REUTERS/Jason Reed   (UNITED STATES HEALTH) - RTXQCTX


EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the EMA and FDA between 2014 and 2016.

The result of the analysis is the EMA and FDA alignment in more than 90% of marketing authorization decisions for new medicines. The most common reasons for discordance were differences in conclusions about efficacy and differences in clinical data submitted in support of an application.

For more information: EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US


Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).

Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information:



The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the human persons study, complies with several ethics requirements stablished in The Helsinki Declaration. All clinical trial protocol should be evaluated by an independent agency whose main objective is to care for clinical trial subjects rights, safety and welfare: The Clinical Research Ethics Committee.

The United States Conference built in the sixty´s the named “National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ”. In 1978, this commission made a document, Belmont Report, which collects bioethics fundamental: Justice, Non-maleficence, Beneficence and Respect for autonomy.

Helsinki Declaration was written by the World Medical Association in 1964, it was the first document which proposed criteria and steps in order to protect subjects who are enrolling in biomedical investigation, several updates have been made, the last one was carried out in Fortaleza, Brazil. Its core principles consist in the need of clinical trial protocol must be approved by an Ethic Committee and the need of obtaining the inform consent form before subject enrolling.

The concern about Ethics in Clinical Research is increasing more and more. Directions about how carrying out any clinical investigation are been stablished with more accuracy because of there are more experts of different knowledge fields involved and are willing to share their point of view.

As can be seen in this publication:, ethics values are constantly changing over time and always there are interests involved which led carrying out a clinical research without complying Helsinki Declaration or another ethic directions. Due to all this, Bioethics has become an essential aspect that always leads to debate.

For more information:


Comunicación de Reacciones Adversas a Medicamentos a eudravigilance.

Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos en la Unión Europea. Esto implica que según lo que establece el Real Decreto 577/2013, por el que se regula la farmacovigilancia de medicamentos de uso humano, los titulares de autorización de comercialización (TAC) deben enviar por medios electrónicos a la base de datos EudraVigilance todas las sospechas de casos individuales de reacciones adversas a medicamentos tanto graves como no graves, atendiendo a las directrices europeas sobre buenas prácticas de Farmacovigilancia.

Esto quiere decir que es obligatorio el envío por parte de los TAC, de todas las sospechas de reacciones adversas graves ocurridas en la Unión Europea y en terceros países, en los quince días naturales siguientes al día en el que haya tenido conocimiento de éstas. Y por otra parte, también tiene obligación de enviar todas las sospechas de reacciones adversas no graves ocurridas en la Unión Europea en los noventa días naturales siguientes al día en el que haya tenido conocimiento de éstas.

En el departamento de Farmacovigilancia de APICES, estamos al día de este cambio de flujo y teniendo en cuenta que sólo es de aplicación en el ámbito post-autorización, nos afecta solamente en aquellos casos de reacciones adversas a medicamentos procedentes de estudios post-autorización (no ensayos clínicos) en los que se requiera notificación por parte de los TAC.

Para más información, se pueden consultar los siguientes enlaces:

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La protección de datos – Nueva regulación adaptada a la era digital

El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas en la Unión Europea, fue aprobado por el Parlamento Europeo en abril de 2016, su ámbito de aplicación se extiende a todos los países miembros de la Unión Europea y se aplica directamente en todos ellos a partir del 25 de mayo de 2018.

Este cambio regulatorio pretende devolver a los ciudadanos el control de sus datos personales y garantizar en toda la UE unos estándares de protección elevados y adaptados al entorno digital. Los ciudadanos pueden decidir por sí mismos qué información quieren compartir.

Entre otras disposiciones, el reglamento incluye:

  • el derecho al “olvido”, mediante la rectificación o supresión de datos personales,
  • la necesidad de “consentimiento claro y afirmativo” de la persona concernida al tratamiento de sus datos personales,
  • la “portabilidad”, o el derecho a trasladar los datos a otro proveedor de servicios,
  • el derecho a ser informado si los datos personales han sido pirateados,
  • lenguaje claro y comprensible sobre las cláusulas de privacidad.

Desde APICES nos hemos adaptado a la nueva regulación y hemos implementado las medidas necesarias para cumplir con la misma, respetando los principios de la protección de datos y permitiendo que las personas ejerzan sus derechos. Puedes acceder a nuestra política de privacidad a través del siguiente vínculo:

En el vínculo siguiente puedes acceder al Reglamento (UE) 2016/679 relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos.

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