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Regulations and Guidelines

Expectations and Detailing of Risk Management Plans in the EU vs Japan

See excel file which supports the backgroud of the above article as printed in Quasar 158 (January 2022).

Download here.

JSQA / RQA Collaboration Pharmacovigilance Quality Systems

Both Japan and the European Union have highly advanced and defined legislation and regulatory expectations for pharmacovigilance. JSQA and RQA have previously collaborated on an overview document for all pharmacovigilance requirements.

In this collaboration an analysis of EU and Japan Quality Management Systems (QMS) to support pharmacovigilance as described in legislation and guidance documents is presented. In this collaborative exercise we provide a comparison of these requirements.

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On 10 July 2012 the “Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council” came into force.

In order to support the implementation of the new legislation for pharmacovigilance, a new set of guidelines for the conduct of pharmacovigilance in the EU is under development which will replace the current set in Volume 9A of the Rules Governing Medicinal Products in the EU.

With the application of the new pharmacovigilance legislation in July 2012, Volume 9A is superseded by the guidance on Good Pharmacovigilance Practices (GVP). However, GVP will indicate where there is a transition period for the implementation of the new requirements and/or where the GVP modules are not yet available. Volume 9A remains the reference as applicable until the transition period ends or until that specific GVP modules are published as final.

Final GVP modules can be found on the EMA website.

Countries in the EU still have their own National Competent Authorities (NCAs) who are bound by the legislation set down by the EC, but may also add or modify the requirements within that particular country. Any nationally approved product will fall under the remit of the NCA of that country that the product is licenseds in. For the UK the NCA is the Medicines Health regulation Authority (MHRA).

Click here to view other NCAs


MHRA Good Pharmacovigilance Practice: The Inspection Process

Click here to view the process which includes types of inspection, actions required by MAHs following notification of inspection, grading of inspection findings, inspection report and company response process and referral to Phamacovigilance Inspection Action Group (PIAG).


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