In an effort to help assessors evaluate initial marketing authorization applications, the European Medicines Agency (EMA) has taken the initiative to extend the use of “early background summaries”.
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
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
In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a reference biological medicinal product authorised in the EU.
On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance document”). Background The aim of this guidance document is to enable marketing authorisation holders (“MAHs”) to submit post-authorisation applications which are in conformity with applicable
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
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
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
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
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
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
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
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
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.
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
On 1 June 2016 the European Commission (“EC”) launched four new public consultations relating to clinical trials.
On 19 May 2016 the European Medicines Agency (“EMA”) published a draft Reflection paper on non-spontaneous adverse event reports (peer-reviewed literature, internet and social media) (“the Draft Reflection Paper”) for veterinary products.
On 11 April 2016 a draft Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (“the Draft Guideline”) were published by the European Medicines Agency (“EMA”).
On 7 April 2016, the European Medicines Agency (“EMA”) announced the launch of a public consultation in the process of drafting Vision and Strategy of the European Surveillance of Veterinary Antimicrobial Consumption (“ESVAC”) (“the Draft Strategy”).
The European Medicines Agency (EMA) has begun running a series of modular training courses to support stakeholders in using EudraVigilance, the centralized database for managing information on suspected adverse reactions reported with medicines authorised in the European Economic Area (EEA).
On 3 February 2016 European Medicines Agency (“EMA’s”) introduced new External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use(“the New External Guidance”).
On 1 February 2016, the European Medicines Agency (“EMA”) launched a public consultation concerning a “Draft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and other dementias”.
On the 12 January 2016, the European Medicines Agency (“EMA”) published an overview of comments in response to a public consultation regarding a “Draft revision of EudraVigilance access policy for medicines for human use”
On 17 December 2015, the European Medicines Agency (“EMA”) published a Reflection Paper on the chemical structure and properties criteria to be considered for evaluation of new active substance (“NAS”) status of chemical substances.