Header graphic for print
Focus on Regulation

Tag Archives: EMA

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

Earlier today, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of [pharmaceutical] manufacturing facilities that meet FDA requirements,” and that the Agency will begin relying “on the inspectional data obtained by these eight regulatory agencies” immediately. 

FDA, EU Regulators Agree to Share Unredacted Inspection Reports and Other Confidential Information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators.  The new confidentiality commitment allows the regulators to share

EMA prepares plan to face Brexit

European Medicines Agency (EMA) has released a business continuity plan dealing with the potential implications of Brexit. EMA, which is currently established in London, will be required to transfer the Agency’s headquarters to another EU Member State. With the aim to conserve Agency’s capacities to protect public and animal health, EMA has issued a press

Personalised Medicines at the top of the European Agenda

In March 2017, the European Medicines Agency organised a workshop concerning personalised medicine. The results of the workshop have just been published. The workshop discussed the views of patients, healthcare professionals and payers regarding personalised medicine. During the workshop future challenges and related actions, that should be taken regarding personalised medicine, were identified. The challenges

The EU Court of Justice dismisses EMA’s appeals in interim measures and suspends the release of clinical study report to third parties

On March, 1st 2017, by Order of its Vice-President, the Court of Justice of the EU (“CJEU”) upheld the suspension of the release to third parties of a clinical study report concerning the medicinal product Translarna granted by the General Court in July 2016. On the same day, by Order of its Vice-President, the CJEU

Extension to the EMA’s Multinational Assessment Team Initiative as of April 2017

Starting in April 2017, the European Medicines Agency (“EMA”) will expand the Multinational Assessment Team (“MNAT”) Initiative to post-authorisation assessments. From this date, the MNAT Initiative will allow national competent authorities not only to participate actively in the development of new medicinal products, but also to be involved in the extensions of marketing authorisations for

EMA hosts workshop on adaptive pathways

On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders on the adaptive pathways approach. The aim of the workshop was to gather stakeholder feedback in light of the practical experience gained during the adaptive pathways pilot project EMA

Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power to clinical data submitted before 1 January 2015

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced

EMA revises Guideline on First-in-Human Trials

On 15 November 2016, the European Medicines Agency (“EMA”) opened for public consultation its updated Guideline on strategies to identify and mitigate risks related to first-in-human and early clinical trials with investigational medicinal products. The EMA has revised the Guideline, in cooperation with the European Commission and the EU Member States, to further improve the

EMA on CVMP strategy on antimicrobials 2016-2020

On 7 October 2016, the European Medicines Agency (“EMA”) issued a press release to announce the adoption by the Committee for Medicinal Products for Veterinary Use (“CVMP”) of the revised CVMP strategy on antimicrobials for the period 2016-2020. Background The present revision of the CVMP strategy on antimicrobials seeks to take into account the scientific

EMA opens public consultation on ICH E11(R1) Guideline

On 13 October 2016, the European Medicines Agency (“EMA”) opened for public consultation the Guideline concerning clinical investigation of medicinal products in the paediatric population, which has been revised to include a new addendum (“R1”). The public consultation opened following the approval of this draft guideline by the International Council for Harmonisation of Technical Requirements

EMA Management Board progresses on New Medicines Web Portal

On 10 October 2016, the European Medicines Agency’s (“EMA”) Management Board adopted a reflection paper on the development of a new European Union medicines web portal. The reflection paper sets out a vision for this new portal and its expected benefits. It also details the means to achieve this vision. Background The new portal, taking

EMA and FDA set up new working group on rare diseases

On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) was announced. This new collaboration is intended to contribute to sharing experiences and best practices on the approach of the two regulators to the development and scientific evaluation of medicines for rare

EMA determines plasma- and urine- derived medicines safe from Zika contamination

On 21 September 2016, the European Medicines Agency (“EMA”) issued a press release to announce that the assessment it carried out along with competent authorities in the EU Member States have confirmed that patients who take plasma-derived or urine-derived medicines do not face increased risk of contamination with the Zika virus. Background Plasma-derived medicines, manufactured

EMA to Revise Herbal Medicines Guideline

On 1 September 2016, the European Medicines Agency (“EMA”) opened for public consultation a Draft revision to its Guideline on the assessment of clinical safety and efficacy in the preparation of European Union herbal monographs for well-established and traditional herbal medicinal products. The consultation deadline for this Draft revision is 30 November 2016.

EMA Publishes New GMP Guidance on Data Integrity

The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance concerning measures intended to ensure data integrity throughout the “data lifecycle” from generation of data, processing, use in decision making, to disposal. The document provides a set of frequently asked questions and answers for companies that process data generated in the process