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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...more

Swissmedic updates requirements concerning the Fast-Track Authorisation Procedure

On 1 October 2017, the Swiss Agency for therapeutic products (“Swissmedic”) updated its guidance document concerning the Fast-Track authorisation procedure (“FTP”). The modified guidance document replaced the formerly...more

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....more

European Commission adopted legal acts to improve Good Manufacturing Practices for medicinal products

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (“GMP”) requirements for investigational and authorised medicinal products in the EU. The purpose of these...more

EMA's reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities....more

EMA Updates Guidance Concerning Medicinal Products Intended Exclusively For Non-EU Countries

The European Medicines Agency (“EMA”) has updated its guidance (Guidance) regarding procedural advice for medicinal products intended exclusively for markets outside the European Union (“EU”). The Guidance addresses several...more

EMA Launches New Submission Form Facilitating Submission Of Post-Authorisation Data

The European Medicines Agency (“EMA”) has issued a new submission form in order to help marketing authorisation holders to submit the post-approval data that is generated to satisfy post-authorisation measures related to...more

EMA released reflexion paper clarifying information related to the selection of starting materials

The European Medicines Agency (“EMA”) has released a reflexion paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances. The reflexion paper provides...more

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...more

EMA released new procedural guide for Multinational Assessment Teams

The European Medicines Agency (“EMA”) has released a procedural guideline for rapporteurs and coordinators participating in Multinational Assessment Teams (“MNAT”)....more

EC issues a new guidance concerning the safety features for Falsified Medicines

The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate...more

EMA proposes new pharmacovigilance practices for the paediatric population

The European Medicines Agency (“EMA”) has proposed a new draft guideline document on good pharmacovigilance practices concerning medicinal products used by the paediatric population. The proposed guideline will replace the...more

EMA's revised guideline on manufacture of the finished dosage form

The European Medicines Agency (EMA) has adopted a new guideline on manufacture of the finished dosage form of medicinal products for human use (“the new Guideline”)....more

EMA further supports Small and medium-sized enterprises (SMEs) with a new Action Plan

The European Medicines Agency (“EMA”) has sought to support Small and Medium-sized Enterprises (SMEs). As part of this effort, the EMA has launched a new Action Plan to address the challenges that confront SMEs and their...more

The European Commission opens a public consultation concerning EU legislation on Blood and, Tissues and Cells

The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire,...more

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...more

EMA envisage to link development of companion diagnostics and personalised medicines

The European Medicines Agency (EMA) has released a concept paper on the development of personalised medicines and companion diagnostics. EMA proposes to develop a guideline that will provide guidance relating to the interface...more

Scientific progress enables EMA to improve guidance on medicinal products containing genetically modified cells

The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified...more

EMA’s revised Guideline on first-in-human trials increases the level of protection of trial participants

The European Medicines Agency (EMA) has released a new Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products. The Guideline was adopted by...more

What does Brexit mean for life sciences companies in the EU and UK? [Video]

Life sciences companies in both the EU and the UK are beginning to speculate on what Brexit will mean for business. In this video, Elisabethann Wright, partner, and Jane Summerfield, counsel, in our European Life Sciences...more

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that...more

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...more

Relocation of the EU Medicines Agency – Ireland Island of Saints and Scholars

The EMA is looking for a new home. In this blog post partner Elisabethann Wright argues the case for Ireland. For thousands of years Ireland has been known as the Island of Saints and Scholars. The country is also world...more

EMA seeks to support the use of patient registries and to improve dialogue between various stakeholders

In September 2015, the European Medicines Agency (EMA) launched the initiative for patient registries. The purpose of the initiative is to improve the benefit-risk evaluation of medicinal products for human use. The EMA’s...more

European Commission publishes recommendations concerning the summary of product characteristics and patient information leaflet...

The European Commission (EC) has published a report (Report) recommending improvements in the summary of product characteristics (SmPC) and the Patient Information Leaflet (PIL) of medicinal products for human use. The report...more

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