The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, introduced a new online application. The online application makes it possible to request a cGMP Declaration (Current Good Manufacturing Practice). A cGMP Declaration can be issued by the FDA to a foreign regulator, such as the competent
Tag Archives: EMA
HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit
On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use. The HMA-EMA task force was created
Access to documents held by EMA: access requests by non-EU applicants to cease
The EMA has announced that, from 15 June 2018. The Agency will cease to accept requests for access to documents by non-EU applicants. The EMA announced that the Agency’s decision was a result of the high volume of access requests and the related excessive administrative workload.
EMA provides guidance on the sponsor’s role in validating electronic systems used in clinical trials
The European Medicine Agency (EMA) has updated its Good Clinical Practice (GCP) Guideline[1] to clarify the level of validation/qualification that needs to be performed by a sponsor in a clinical trial setting when using an electronic system previously qualified by a vendor. The updated Guideline, issued in the form of a Q&A document, provides that
The EMA opens a draft guideline for handling and shipping of investigational medicinal products for human use for public consultation.
On 23 May 2018, the European Medicine Agency (EMA) launched a public consultation for a draft guideline concerning the responsibilities of trial sponsors for handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The draft guideline provides the principles for the two step release
New version of EMA’s pre-authorisation procedural advice for the centralised procedure released
On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. The document contains revisions regarding the EMA marketing authorisation application numbers. It also includes changes related to oral explanations during the assessment procedure of the marketing authorisation application. Background The
eCTD Format Required for all Mutual Recognition Procedure Submissions
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”).
EMA provides essential considerations to be taken into account for successful qualification of novel methodologies
The European Medicines Agency has published a checklist for applicants seeking qualification of novel methodologies.
EMA published an assessors’ guidance document in connection with explanatory note to GVP module VII
The European Medicines Agency has published a guidance document for assessors written in questions-and-answers. It should be read in combination with the explanatory note to GVP module VII.
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.
EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit
Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period.
EMA publishes external guidance for clinical data publication
On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use.
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
Ministers Provide Insight on the UK’s Position on the Regulation of Medicines post-Brexit
With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening. On 3
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
EMA’s initiative of expanding the use of early background summaries
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”.
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 pilot project on tailored scientific advice to support new biosimilars
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.
EMA post-authorisation procedural advice for users of the centralised procedure
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
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