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Feb 9, 2016

This document provides guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND.

This guidance is a follow-on to the guidance for industry and investigators Safety Reporting Requirements for INDs and BA/BE Studies and provides recommendations for how sponsors of INDs can identify and evaluate important safety information that must be submitted to FDA and all participating investigators under the IND safety reporting regulations.

This guidance contains recommendations on the following: (1) the composition and role of a safety assessment committee, (2) aggregate analyses for comparison of adverse event rates across treatment groups, (3) planned unblinding of safety data, (4) reporting thresholds for IND safety reporting, and (5) the development of a safety surveillance plan.

The December meeting of the European Medicines Agency's management board offered tidings of less than total comfort and joy to the clinical trials community. The agency's holiday message was a disappointment to those hoping for rapid progress on bringing Europe's new clinical trials rules into effect. The legislation, finalized in May last year—that is, 2014—said the new regulation would not be in force before May next year—that is, 2016. But the EMA board, which had already admitted that 2017 was a more likely date, disrupted the festive season with the news that the horizon for the clinical trial rules had shifted still further away, and is now October 2018.

The announcement has provoked some sharp reactions among those battling with the incoherencies of the EU's current rules on clinical trials—which the new regulation was designed to remedy. The agency's protestations of the need for a meticulous approach have not assuaged the impatience of development staff still laboring through the complexities of the much-criticized 2001 directive.

Statistics from the Federal Criminal Police Office show that the number of corruption-related offences committed in 2013 increased to 3,995. The new regulation on taking and giving bribes in commercial practice under Section 299 of the Criminal Code is intended to implement international standards in light of growing cross-border corruption. After intensely controversial hearings and some late changes, the new anti-corruption law was passed by Parliament and came into force on November 26 2015.

This will have some implication on compliance and its functions:

This new system is a web based portal which will replace the existing functional email addresses used to communicate in respect of a specific EMA supported IT system (e.g. art57@ema.europa.eu for queries relating to Article 57, ev@ema.europa.eu for EudraVigilance, eudract@ema.europa.eu for EudraCT and euctr@ema.europa.eu for EU CTR etc). Thus, from 1 February, functional email addresses on EMA webpages will be replaced with a link to the self-service portal, where applicable.

This portal will improve the efficiency and effectiveness of the technical support provided by allowing users to request IT services, report technical issues, track progress and obtain answers to frequently asked questions – all in one place.

Things to remember as of 1 February 2016:

To log in into this new portal, users will need to register to the new portal (a one-time, automated process), if not already registered for any of the Agency’s other systems (e.g. EudraCT).

All technical IT requests and issues in relation to EMA supported IT systems will be dealt with through this portal. Any ongoing incidents or service requests that were logged before 1 February will be handled using the existing process.

The existing support email addresses will not be monitored from 1 February. Those that send emails to any of those addresses (if, for instance, they have saved the address) will receive an automated response that will include a link to the new portal.

The European Parliament and Council have reached agreement on the data protection reform proposed by the Commission. The reform is an essential step to strengthen citizens' fundamental rights in the digital age and facilitate business by simplifying rules for companies in the Digital Single Market.

The data protection reform package includes the General Data Protection Regulation ("Regulation") and the Data Protection Directive for the police and criminal justice sector.