Latest Publications


Digital Health: CE marking of medical devices

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. ...more

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...more

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products,...more

European Commission released GMP Guidelines for Investigational Medicinal Products

On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. ...more

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”)....more

EMA released Practical Guidance for Brexit and Market Authorisation Holders

The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”) will be required to take should the United Kingdom (“UK”) become a third...more

EMA provides essential considerations to be taken into account for successful qualification of novel methodologies

The European Medicines Agency (“EMA”) has published a checklist of the essential considerations to be addressed for successful qualification of novel methodologies....more

EMA published an assessors’ guidance document in connection with explanatory note to GVP module VII

The European Medicines Agency (“EMA”) has released a guidance document for assessors. The guidance document is written in a questions-and-answers form. It should be read in combination with the explanatory note to GVP module...more

EMA launched improved version of EudraVigilance

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

Publication of the notified bodies’ designation codes under the MDR and IVDR

The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”) has...more

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

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