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Tag Archives: European Medicines Agency

European Medicines Agency’s new guide on the wording of therapeutic indication

1.            Introduction On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in therapeutic indications. The therapeutic indication is the primary information concerning the use of a medicinal product. The guide provides that therapeutic indications should clearly state

EMA’s pre-authorisation procedural advice for the centralised procedure updated

The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of the dossier. Background The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely

EMA Begins Publishing the Outcome Of Safety Reports Concerning Nationally Authorised Medicinal Products

On 6 July 2015, the European Medicines Agency (“EMA”) announced that it would begin publishing the outcome of single assessments of period safety update reports (“PSURs”) for active ingredients contained in nationally authorised medicinal products. Periodic safety update reporting is performed during certain stages of the post-authorisation phase of the medicinal product. The report provides

EMA publishes a draft Q&A document for consultation on the environmental risk assessment guidelines

On 26 March 2015, the European Medicines Agency (“EMA”) published a draft Questions and Answers Document (“Q&A Document“) for consultation concerning the EMA’s Guideline on the environmental risk assessment of medicinal products for human use (“EMA Guideline“). The purpose of the Q&A Document is to clarify and harmonise the use of the EMA Guideline. The

EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars

The European Medicines Agency’s (“EMA”) revised overarching guideline on biosimilars (“Guideline”), which was published on 23 October 2014, will come into force on 30 April 2015. The purpose of this Guideline is to describe the concept of biosimilars and to outline the general principles to be applied when generating evidence substantiating the similar nature, in

EMA confirms that access to clinical study reports for preparation of Health Technology Dossiers will be permitted within the new EMA Disclosure Policy

According to the minutes of a meeting between the European Medicines Agency (“EMA”) and the European Network for Health Technology Assessment (“EUnetHTA”) held on 9 December 2014, the EMA has clarified that pharmaceutical companies may use clinical data made available as part of the EMA’s new Disclosure Policy as part of a Health Technology Assessment


On 22 January 2015, the Sixth Chamber of the General Court of the Court of Justice of the European Union (“General Court”) issued its judgment in Case T‑140/12 Teva Pharma and Teva Pharmaceuticals Europe v EMA concerning market exclusivity for orphan medicinal products. As part of the General Court’s judgment, the Court examined the possibility

The EMA Publishes New Biosimilars Guideline on Non-Clinical and Clinical Issues

Following its adoption by the Committee for Medicinal Products for Human Use (“CHMP”) on 18 December 2014, the European Medicines Agency (“EMA”) recently published a finalised version of its Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (hereafter “EMA Guideline”). The revised EMA Guideline is expected to come into force in July 2015 and will replace the current guideline which came into effect in June 2006.


The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide”).

In accordance with European Union (“EU”) law, any person may request access to unpublished documents held by the EMA. The Guide is intended to provide practical guidance concerning the process for requesting access to these documents. The new Guide is in the form of a Questions and Answers document and includes a flow chart of the access-to-documents process.


On 1 October 2014 the European Medicines Agency (“EMA”) opened a consultation on revisions to its guideline on core summary of product characteristics (“SmPC”) for human plasma derived and recombinant coagulation factor IX products (the “Guidelines”).

The Guidelines are intended to provide harmonised guidance to applicants and regulators regarding the information that is to be included in the SmPC for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment of prophylaxis of bleeding in patients with haemophilia B.

Revisions to European Medicines Agency Guidance on Good Pharmacovigilance Practices in Adverse Event Reporting

On 16 September 2014, new revisions to the European Medicines Agency (“EMA”) guidance on good pharmacovigilance practices came into effect. The EMA provides guidance on good pharmacovigilance practices (“GVP”) to facilitate the performance of pharmacovigilance in the European Union (“EU”). They apply to marketing authorisation holders, the EMA and competent authorities in EU Member States.


On 10 February 2014, the European Medicines Agency (“EMA”) published a revised Questions & Answers document. The document supports the implementation of the European Commission Guidelines on the details of the various categories of variations (“Variations Guidelines“). The aim of the document is to address questions that marketing authorisation holders may have in relation to the

EMA publishes a Questions & Answers document on the practical implementation of Article 31 Pharmacovigilance Referral procedure

On 20 January 2014, the European Medicines Agency (“EMA”) published a Questions & Answers document discussing the practical implementation of the “Article 31 Pharmacovigilance Referral” procedure. The aim of the document is to address questions that marketing authorisation holders may have in relation to this procedure and the manner in which it is handled by