Clinical Trials In Human Medicines as per EU

Clinical Trials In Human Medicines as per EU:

For its opinions on the approval of medicines, the European Medicines Agency (EMA) relies on the results of clinical trials carried out by pharmaceutical companies. While clinical trials are approved at the national level, the EMA has a major role in ensuring that Good Clinical Practice (GCP) is followed across the European Economic Area (EEA). Additionally, it manages a database of clinical trials conducted in the European Union (EU).

Clinical trials are studies designed to verify or discover the effects of medicine under investigation.

The regulation of clinical trials is aimed at protecting the rights, safety, and wellbeing of subjects while ensuring the validity of the results.

The requirements specified in Annex 1 of Directive 2001/83/EC must be met for all clinical trials included in applications for marketing authorization for human medicines in the EEA. This means:

  1. In order to conduct clinical trials in the EEA, compliance must be met with EU clinical trial legislation (Directive 2001/20/EC);

2. The Declaration of Helsinki and international good clinical practice must be adhered to by trials conducted outside of the European Economic Area.

There are about 4,000 clinical trials approved every year in the EEA. A clinical trial involving the participation of an average of two Member States brings the total to roughly 8,000.

In general, about 61% of clinical trials are sponsored by the pharmaceutical industry, and 39% by non-commercial sponsors, primarily academic institutions.

EMA’s role in clinical trials:

A human medicine seeking EU-wide marketing authorization is assessed by the CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency.

The CHMP considers data from clinical trials included in applications as part of the scientific evaluation process.

As a major part of the application dossiers submitted by pharmaceutical companies seeking marketing authorization via the Agency, clinical study data is included in clinical trial reports.

In accordance with EU legislation, in particular Directive 2001/83/EC, assessments are based on simple, scientific criteria to determine whether or not a medicine meets the required quality, safety, and efficacy requirements.

The EU Clinical Trials Register and the EudraCT database:

The European Medicines Agency is responsible for developing, maintaining and coordinating the EudraCT (European Union Drug Regulating Authorities Clinical Trials) database.

Using EudraCT, national competent authorities enter clinical trial data from clinical trial sponsors and pediatric investigation plan (PIP) recipients.

The European Union Clinical Trials Register, managed by the Agency on behalf of member states, delivers a subset of this data.

The following information is available to users:

  • A description of phase-II to phase-IV adults clinical trials conducted within the European Economic Area;
  • Description of clinical trials in children involving investigator sites situated within the EU, as well as trials included in a PIP, including those conducted outside the EU.

These summary results are determined by the technical guidance of the European Commission and in its guideline.

Summarizing results usually provides information about the objectives of a study, explains how it was designed, and highlights its main results and conclusions.

Since July 2014, sponsors must post clinical trial results to EudraCT.

As of July 2019, EMA published a letter co-signed by the European Commission and the Heads of Medicines Agencies (HMA) reminding everyone associated with or sponsoring a clinical trial in the EU of their obligations to make their research results publicly available in the EudraCT database:

Clinical trials that were approved but never started or that started but were terminated early will be able to post their results to the EudraCT database from October 2020.

Sponsors should provide reasons and partial results, if available.

Pharma companies submitting clinical reports to support their regulatory applications for human medicines are subject to a separate policy at the Agency.

Regulations governing clinical trials:

The European Commission adopted the new Clinical Trial Regulation (EU No 536/2014) on 16 April 2014, repealing Directive 2001/20/EC.

In spite of the fact that the Clinical Trial Regulation was adopted and entered into force in 2014, it will take an independent audit to verify the full functionality of the Clinical Trial Information System (CTIS) before its application.

After the EU Commission publishes a notice of this confirmation, the Regulation becomes applicable six months later.

For more information refer to clinical trial regulation.




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