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Jul 1, 2016

Changes to PSUR submission in the EU
Mandatory use of the PSUR submission repository

The PSUR repository is a common storage place for PSURs, regulators’ PSUR assessment reports, comments and final outcomes. National Competent Authorities (NCAs) have direct, secure access to the repository. More information on the PSUR repository can be found here:

From 13 June 2016, it is mandatory for all MAHs in the European Union (EU) to submit PSURs for human medicines directly to the PSUR repository. This means that companies must use the repository as a single point for all submissions and should no longer submit PSURs to NCAs directly.

The PSUR repository is mandatory for both centrally and nationally authorised medicines whether they follow the EU single assessment or a purely national assessment procedure. The PSUR repository is intended for PSURs for human medicines only.

PSURs that have not been sent to the PSUR repository are considered as not submitted and will not be assessed. PSURs not sent to the PSUR repository will not fulfil the MAH’s legal obligation to submit PSURs.

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Brexit implications on Pharmacovigilance
A comment from Dr Oliver Hellstern

The UK leaving the European Union might have severe implications on the Pharmacovigilance landscape. Dr Oliver Hellstern, PV Practice leader at Widler & Schiemann comments.

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Brexit vote sets off race to seat European Medicines Agency
A race to house the European Medicines Agency will begin in earnest after Britain voted to leave the European Union

The result means the EMA will no longer be able to continue its operations from London, and medicines will need an additional, costly, regulatory process to launch their products in Britain as well as in EU member countries.

Officials in Italy, as drug makers in Sweden and Denmark, have all expressed interest in taking over as host country.

Read more in the article published by “Politico” on June 24th:

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FDA webinar on expanded access and the new individual patient expanded access application
This is part of a series of educational webinars targeting the needs of all healthcare professionals

On July 12, 2016 at 1pm (EST), CDER's Office of Communication, Division of Drug Information (DDI) will host a webinar titled: An Overview of FDA’s Expanded Access Process and the New Individual Patient Expanded Access Application. The panel presenters will be Richard Klein, Director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs (OHCA), Peter Lurie MD, MPH, Associate Commissioner for Public Health Strategy and Analysis, Office of the Commissioner and Colleen Locicero, RPh, Associate Director for Regulatory Affairs in the Office of Drug Evaluation I in FDA’s Center for Drug Evaluation and Research (CDER). The presenters will discuss and summarize the purpose of FDA’s expanded access program, including the types of expanded access requests accepted by FDA.

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Annex 16 Revision: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
Annex 16 to the EU Guide to GMP provides specific guidance on certification by a QP and batch release

The updated version of this document has come into effect in April this year. Previous guidance on dealing with minor deviations from the MA had been issued by the European Medicines Agency in their 2009 “reflection paper” EMEA/INS/GMP/227075/2008. However, there have been questions over the status of this paper, and its use was not consistently applied. It is important to note that the guidance in Annex 16 is new and not simply a rewrite of the EMA paper.

The revised Annex 16 to the EU Guide to GMP provides new guidance on dealing with deviations from marketing authorisations, with the aim of ensuring consistency across the EU.

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Improving safety of first-in-human clinical trials
EMA starts EU-wide reflection on necessary changes to best practices

The European Medicines Agency (EMA) has started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union (EU).

The review will identify which areas may need to be revised in the light of the tragic incident, which took place during a Phase I first-in-human clinical trial in Rennes, France, in January 2016. The trial led to the death of one participant and hospitalisation of five others.

EMA’s review will take into account the findings from two in-depth investigations into what went wrong during this trial, one carried out by the Temporary Specialist Scientific Committee (TSSC) set up by the French medicines agency ANSM and the other by the Inspection générale des affaires sociales (IGAS), the inspectorate for social affairs in France.

Both reports include a series of recommendations regarding the requirements for authorisation and conduct of first-in-human clinical trials for further examination by the international regulatory and public health community.

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