TMQA Latest News

FDA issues guidance agenda on new and draft guidances it plans to publish in 2015

Earlier this month the FDA’s Center for Drug Evaluation and Research (CDER) published a list of new and revised guidances that it plans to publish during 2015. Those relating to clinical trials include, but are not limited to:

  • Pregnant Women in Clinical Trials – Scientific and Ethical Considerations
  • Multiple Endpoints in Clinical Trials
  • Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators
  • Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers

The full list can be found on the FDA website:

EMA recommends suspending medicines over flawed studies

The EMA has recommended that a number of medicines, whose authorisation in the EU was primarily based on clinical studies conducted by the Indian CRO, GVK Biosciences, should be suspended.  The recommendation is the result of a review carried out by the EMA of over 1000 pharmaceutical forms and strengths of medicines studied at the GVK Biosciences’ facility in Hyderabad, India.

Concerns over this facility were raised following an inspection by the French Regulatory Authority which revealed data manipulation of ECGs during the conduct of some studies of generic medicines. For over 300 of the pharmaceutical forms and strengths studied at GVK, sufficient supporting data from other sources were available, hence these will remain on the market in the EU as the EMA is satisfied with the available data.  For those medicines that lack the data from other studies, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.

The full list of medicines for which the CHMP recommends suspension is available on the EMA website.


EMA launches electronic platform for Safety Reports


On 26 Jan 2015, the EMA launched a central electronic repository to facilitate assessment of medicines safety reports.  This repository has been created in accordance with the pharmacovigilance legislation of the EU and will contain all information related to Periodic Safety Update Reports (PSUR) in the EU and will allow assessment of PSURs by medicines regulatory authorities in the EU.

Pharmaceutical companies are required to submit PSURs to the EMA on a periodic basis.  The PSUR summarises the results of an evaluation by the pharmaceutical company of the benefits and risks of the authorised medicine.  The EMA then uses this information to determine if new risks are identified or if the risk-benefit balance of a medicine has changed and to take appropriate action.  The central repository stores PSURs, PSUR assessment reports, comments, and final outcomes, and gives secure access to authorised users from national competent authorities in EU Member States, the EMA, Agency committees, and the European Commission. It ensures that all those involved in benefit-risk assessments of medicines have timely access to all relevant documents in one location.

Webinars on the PSUR repository for the pharmaceutical industry will be organised in Feb 2015 followed by weekly question and answer sessions.


EMA launches public consultation on application of the transparency rules of the Clinical Trials Directive

On 21 Jan 2015, the EMA launched a public consultation on how the transparency rules of the new Clinical Trials Regulation will be applied in the new EU clinical trial database. The Clinical Trials Regulation transforms the amount of information that is publicly available for each clinical trial conducted in the EU by requiring transparency on the authorisation, conduct and results of trials.

The new EU portal and EU database will provide the system that will be used to submit and maintain clinical trial applications and authorisations in the EU and will serve as the source of public information on the clinical trial applications assessed, and all clinical trials conducted in the EU.

While the EMA is responsible for the development and maintenance of the EU portal and EU database, it is the EU Member States that are responsible for authorisation and oversights of clinical trials in the EU. The public will be able to access detailed information about each trial with a summary of the results and a lay summary being published 12 months after the end of the trial.  For trials included in a marketing authorisation application in the EU, clinical study reports will be published 30 days after the procedure for granting the marketing authorisation has been completed or the application has been withdrawn.

The document under consultation sets out proposals for the application of the transparency rules of the European Clinical Trial Regulation for stakeholders to review and comment on. Comments are invited before 18 Feb 2015. The European Clinical Trial Regulation is distinct from the EMA’s policy on the publication of clinical trial data, which came into force in Jan 2015. Under the EMA’s policy, the EMA proactively publishes the clinical study reports submitted as part of marketing authorisation applications for human medicines. This means that the policy applies to clinical reports of studies that are beyond the scope of the European Clinical Trial Regulation as it, for example, also includes clinical trials that are conducted outside the EU but submitted to the EMA for marketing authorisation in the EU.


EMA releases functional specifications for EU Portal and EU Database to be audited

In October 2014, the European Medicines Agency (EMA) launched a public consultation on the draft functional specifications for the EU portal and EU database.  Stakeholders were invited to review these specifications and provide comments by 31 Oct 2014. Following this and final consultation by the European Commission and EU Member States, the functional specifications for the EU portal and EU database were released by the EMA on 19 Dec 2014.

The EU portal and EU database are required to support the harmonised approach to the submission, assessment and reporting of clinical trials established by the new Clinical Trials Regulation (EU) No. 536/2014. All information that is submitted via the EU portal will be stored in the EU database. The application of the Clinical Trial Regulation is conditional on the conduct of an audit of the EU portal and EU database to show that the system has achieved full functionality.  Thus, the aim of the document released by the EMA is to draw up the functional specifications to be audited. The legal basis for the audit of the EU portal and EU database can be found in the Clinical Trial Regulation which states the following:

  • The Agency [EMA] shall, in collaboration with the Member States and the Commission, set up and maintain a portal…as a single entry point for the submission of data and information relating to clinical trials. Data and information submitted through the EU portal shall be stored in the EU database.
  • The Agency shall, in collaboration with the Member States and the Commission, set up and maintain a database. The EU database shall contain the data and information submitted in accordance with this Regulation [Clinical Trials Regulation].
  • The Agency shall, in collaboration with the Member States and the Commission, draw up the functional specifications for the EU portal and EU database, together with the timeframe for their implementation.
  • The Management Board of the Agency shall, on the basis of an independent audit, inform the Commission when the EU portal and EU database have achieved full functionality and meet the functional specifications.