European Medicines Agency





The European Medicines Agency has released for public consultation three guidelines on good pharmacovigilance practices (GVP):

·        Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)

This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU). Recommendations regarding the reporting of emerging safety issues or of suspected adverse reactions occurring in special situations are also presented in this Module.

·        Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)

Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter III]. In this Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.

·        Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal detection. The monitoring process is facilitated by statistical summaries of the information received for each “drug-event” combination over defined time periods.

Comments should be sent to using the template provided in each guideline. The deadline for comments is 14 October 2016.


The European Medicines Agency has released for public consultation a concept paper on the revision of the 'Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products'

The current guideline mainly focuses on non-clinical aspects of drug development and the use of animal data and reflects the practice at the time it was developed which focused on a single ascending dose (SAD) design for first-in-human (FIH) trials.  

Since then, integration of the non-clinical data available before FIH administrations and the pharmacokinetic (PK), pharmacodynamic (PD) and human safety data emerging during a trial has also evolved. Consequently, the practice has evolved and many FIH trials are now performed with integrated protocols potentially combining a number of different study parts, e.g. single and multiple ascending doses (SAD and MAD), food interaction, different age groups and early proof of concept or early proof of principle parts. FIH and early phase CTs with multiple study parts are, therefore, increasingly being submitted for regulatory review to National Competent Authorities as part of a single CT application.

The document open for consultation is available by clicking here.

Comments should be provided using this template. The completed comments form should be sent to

Please note that the deadline for comments is 30 September 2016.


The 2015 annual report of ‘EMA interactions with patients, consumers and healthcare professionals and their organisations’ has been published and can be found on the dedicated pages for Patients and Consumers and Healthcare Professionals.