This page lists questions that marketing-authorisation holders (MAHs) may have on transparency. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
A PDF version of the entire post-authorisation guidance is available:
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.
Since the establishment of EMA, transparency has been an important feature of the Agency’s operation. This resulted in the introduction of the European Public Assessment Reports (EPARs) in line with the requirements of the Community legislation. European Union (EU) law sets the minimum level of transparency that the Agency must apply. However, in many areas, the Agency has decided to go beyond what law requires, so that it can provide as much information to the public as possible. In all cases, it takes care to balance this with the protection of commercially confidential information and personal data.
An overview of the EMA transparency measures are presented on the Transparency page on EMA’s website.
The Agency has also published a guide to information on human medicines evaluated by EMA which describes the different types of information the Agency currently publishes for both centrally and non-centrally authorised medicines, as well as publication times and location on EMA’s website. The guide aims to help stakeholders know what kind of information to expect on medicines undergoing evaluations and other regulatory procedures.
In addition, the public has the right to request information and documents from the Agency in accordance with its rules on access to documents.
- 1. Which EMA transparency measures apply for on-going marketing authorization application procedures? Rev. August 2016
Information on on-going medicine evaluations is published on EMA’s website under Find Medicine-Medicines under evaluation. Information published relates to the INNs and therapeutic areas for each medicine under evaluation.
For more detailed information please refer to the guide to information on human medicines evaluated by EMA which describes all the information publicly available for on-going procedures.
- 2. Which transparency measure applies for the publication of assessment reports? Rev. August 2016
For information on the publication of assessment reports including a description of the documents that the EPAR comprises, all the circumstances that require an update of the EPAR and the information available before an EC decision is issued please refer to the Guide to information on human medicines evaluated by EMA. This guide also includes tabulated overviews of EMA documents, including their location and publication time.
- 3. Which transparency measures apply with regard to EMA’s scientific committees? NEW August 2016
For transparency measures regarding the publishing of agendas, minutes and meeting highlights/reports for the different EMA’s committees, please refer to the Guide to information on human medicines evaluated by EMA.
- 4. Which specialised databases are publicly available? Rev. August 2016
Side effects of medicines
Information on suspected side effect reports is available in the European database of suspected adverse drug reaction reports. This website allows users to view the total number of individual suspected side effect reports submitted to the EudraVigilance database for each centrally authorised medicine and also for some active substances contained in nationally authorised medicines. Users can sort the suspected side effect reports by age group, sex, type of suspected side effect and outcome.
The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA), including therefore also Iceland, Liechtenstein and Norway,which started after 1 May 2004.
Clinical trials conducted outside the EU/EEA are included if:
- they form part of a paediatric investigation plan (PIP), or
- they are sponsored by a marketing authorisation holder, and involve the use of a medicine in the paediatric population as part of an EU marketing authorisation.
The EU Clinical Trials Register also displays information on more than 18000 older paediatric trials, which were completed by 26 January 2007 (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
GMP and GDP inspections
Information on inspections of manufacturers, importers and distributors as well as their authorisations and registrations issued by regulatory authorities are available in a public database called EudraGMDP.
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency (EMA). The members of this network (the ENCePP partners) are public institutions and contract and research organisations (CRO) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests are not restricted to the safety of medicines but may include the benefits and risks of medicines, disease epidemiology and drug utilisation. Participation to ENCePP is voluntary.
ENCePP aims to strengthen the monitoring of the benefit-risk balance of medicinal products in Europe by:
- Facilitating the conduct of high quality, multi-centre, independent post-authorisation safety studies (PASS) with a focus on observational research;
- Bringing together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe and providing a platform for collaborations;
- Developing and maintaining methodological standards and governance principles for research in pharmacovigilance and pharmacoepidemiology.
The ENCePP website hosts the EU PAS Register which is a publicly available register of non-interventional post-authorisation safety studies (PASS). The Register has a focus on observational research, and its purpose is to increase transparency, reduce publication bias, promote the exchange of information and facilitate collaboration among stakeholders, including academia, sponsors and regulatory bodies, and ensure compliance with EU pharmacovigilance legislation requirements. Information on post-authorisation efficacy studies (PAES) that are not clinical trials (i.e. outside the scope of Directive 2001/20/EC ) should also be entered in the EU PAS Register to support transparency on post-authorisation efficacy studies (PAES), whether they are initiated, managed or financed by a marketing authorisation holder voluntarily or pursuant to an obligation.
Parallel distribution notices
The public register of parallel distribution notices, launched in July 2015, provides up-to- date information on parallel distribution notices currently held by EMA.
- 5. Does the EMA provide monthly figures on centralised procedures for human medicines? Rev. August 2016
Monthly Statistics reports on medicinal products for human use (with latest cumulative figures for the current year) are published on EMA’s website. These documents provide current information related to the volume and outcomes of evaluations of marketing authorisation and post-authorisation applications received by EMA. The purpose is only to provide on-going factual information. Commentaries and analysis are provided in the EMA’s annual reports.
The published Monthly Statistics reports can be found on the EMA’s website under News and events-Statistics.
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