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Tag Archives: EMA

EMA publishes draft guideline on the quality of water for pharmaceutical use

Introduction The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent

The EMA launches a public consultation on eSource Direct Data Capture in clinical trials

The European Medicines Agency (EMA) has published a draft qualification Opinion[1] concerning the use of eSource Direct Data Capture (DDC) in the conduct of clinical trials in the EU. The draft Opinion was adopted by the Agency’s Committee for Medicinal Products for Human Use (CHMP). It presents CHMP’s views on the “regulatory acceptability” of eSource

EMA launches public consultation on the use of patient disease registries for regulator purposes

Introduction On 5 November 2018, the EMA published a discussion paper concerning the use of patient disease registries for regulator purposes. The discussion paper was published within the context of the EMA’s Patient Registries Initiative (PRI). The consultation period is open to stakeholders until 29 June 2019. It has been published to allow stakeholders to

The EMA has adopted new guidelines on good pharmacovigilance practices in paediatric populations

Introduction The EMA Good Pharmacovigilance Practices consist of several chapters of the Notice to Applicants that are regularly updated. A new GVP Considerations Chapter (IV) regarding specific considerations for the paediatric population came into effect on 8 November 2018. The Considerations Chapter addressed pharmacovigilance issues that frequently arise with the paediatric population and related pharmacovigilance

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

The reflection paper and extrapolation The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. The main focus of the reflection paper is to provide a framework and guidance for the use of extrapolation in the development of medicinal products in paediatric patients.

A broader definition of “unmet needs” has been proposed to support the development of anti-bacterial medicinal products

The concept paper The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.” In the Concept Paper, the EMA proposes to merge the “Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2)” with

The FDA now offers cGMP Declarations

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

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

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

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