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The article reports that the European Medicines Agency (EMA) is inviting public comments on a reflection paper regarding development of medicines for older people as of January 2018.

The article discuses the The Joint Interagency Antimicrobial Consumption and Resistance Analysis report on antibiotic consumption and antibiotic resistance from the European Food Safety Authority, the European Medicines Agency, and the European centre for Disease Prevention and Control.

The anonymisation report (AR) is a new and relatively unknown regulatory document, submitted as part of the redacted package of a marketing authorisation application under the EMA Policy 0070. The report documents the methodology of anonymisation in each package and the rationale for these methods. As of December 31, 2017, 64 ARs have been published on the clinical data website of the European Medicines Agency. A preliminary high-level analysis of these reports was performed, with the aim of gaining information on the current industry practices in anonymisation and AR preparation. After excluding 12 ARs from packages that did not contain protected personal data, 52 ARs were analysed. Information on anonymisation methodology, re-identification risk assessment, data utility assessment, and use of software is presented. [ABSTRACT FROM AUTHOR]

The article informs that the European Medicines Agency (EMA) has given public access to clinical reports for new medicines for human use authorized in the European Union (EU) and citizens will be able to access clinical data submitted by pharmaceuticals to EMA.

The article informs about the changes made with the guidelines on first-in-human clinical trials by European Medicines Agency (EMA) with European Commission and members of European Union (EU). Topics include opening of EMA's revised guideline for public consultation until 28 February 2017; tragic incident took place during phase I first-in-human clinical trial in Rennes, France; role of non-clinical data in the definition of the estimated therapeutic dose, maximal dose, and dose intervals.

The article focuses on the adoption of final rules of procedure for public hearings by committee Pharmacovigilance Risk Assessment Committee (PRAC) of the agency responsible for public and animal health through supervision of medicines European Medicines Agency (EMA). The rules of procedure explain the process and practical arrangements for the preparation, conduct and follow-up of public hearings. The article discusses the internal dry run exercise to test the process on July 2016.

This section offers news briefs about the activities of the European Medicines Agency (EMA). Members of the EMA and its scientific Committees support the use of adaptive pathways in drug development. The EMA decided to share its assessments of applications for generic medicines outside the European Union (EU). The revised documentation related to pediatric investigation plans (PIP) is published by the EMA.

The European system of approval of new medicines comprises an European Union (EU)-wide authorisation procedure (the so called centralised procedure) alongside national procedures based on different EU Member States working together and recognising each other's evaluations (the so called decentralised and mutual recognition procedures). It is a system that has evolved over the past half century from one with wholly separate national systems to one where EU countries now harness their regulatory and scientific expertise to harmonise and improve the evaluation of medicines across Europe. Today, the purely national procedure is rarely used by applicants and only when they seek marketing authorisation in a single Member State. Although the different procedures may give an impression of complexity, they have simplified the authorisation process across Member States, reducing the times for new medicines to obtain marketing authorisation and improving patient access to new medicines. [ABSTRACT FROM AUTHOR]

The article focuses on the periodic safety update report (PSUR) repository developed by agency for protection of public and animal health through supervision of medicines European Medicines Agency in collaboration with European Union (EU) Member States and industry. It discusses the single storage platform for PSURs and related documents to be used by all regulatory authorities and pharmaceutical companies in the EU. It mentions its introduction by the EU pharmacovigilance legislation.

The article focuses on the review started by agency for protection of public and animal health through supervision of medicines European Medicines Agency (EMA) of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. It discusses the review being done in cooperation with the European Commission and Member States of the European Union (EU). It mention the need for improving safety of human volunteers in trials.

The article reports that the vast majority of investigator brochures lack sufficient information to systematically appraise the strength of the supporting preclinical findings as per investigation of 109 investigator brochures (IBs) reported in an April 2018 issue of the journal "PLoS Biology." Topics include the IBs covered 8 of 12 therapeutic areas as distinguished by the European Medicines Agency.

The article focuses on the referendum of June 23, 2016 and discusses statement by the agency for protection of public and animal health through supervision of medicines European Medicines Agency (EMA) on the outcome of the referendum and continuance as usual of EMA's procedures and work streams.

The article focuses on the move from August 1, 2016 from printouts to electronic documents by the agency for protection of public and animal health through supervision of medicines European Medicines Agency to transmit opinions of the Paediatric Committee and EMA decisions.