Pharmacovigilance Archives | European Regulatory Affairs Specialists

BREXIT – MHRA post-transition period information

6th November 2020

The UK has left the EU and the transition period after Brexit comes to an end this year.

The MHRA have issued new guidance for industry and organisations effective from 01^st January 2021. From this date the MHRA will be the UK’s standalone medicines and medical devices regulator.

Areas covered in the new guidance include:

Clinical Trials

From 1 January 2021, for registering clinical trials, existing and established international registers will still be used, such as ISRCTN registry (UK), or ClinicalTrials.gov (USA), to ensure the public is aware of your trial. For trials involving both UK and EU sites a record in the EU Clinical Trials Register will exist (other than adult Phase 1 studies). In the UK, any favourable opinion given by a research ethics committee is subject to the condition that the clinical trial is registered on a publicly accessible database. The time frame for publishing the summary of results is within 6 months of the end of trial for paediatric clinical trials or within one year of the end of trial for non-paediatric clinical trials. You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to CT.Submission@mhra.gov.uk once the result-related information has been uploaded to the public register and provide a link.

Pharmacovigilance

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021

From 1 January 2021, the following legal obligations will apply to holders of UK marketing authorisations (MA). These include those that cover the whole of the UK, or are specific to Northern Ireland or to Great Britain (England, Wales and Scotland):

To operate a pharmacovigilance system for UK authorised products.
To have an appropriately qualified person responsible for pharmacovigilance (QPPV) that resides and operates in the EU or the UK and is responsible for the establishment and maintenance of the pharmacovigilance system for UK authorised products.
To maintain and make available upon request a pharmacovigilance system master file (PSMF) that describes the pharmacovigilance system for UK authorised products. The PSMF must be accessible electronically or physically from the UK at the same site at which reports of suspected adverse reaction may be accessed.

Statutory guidance concerning the QPPV for UK authorised products is described in the Good Pharmacovigilance Practices (GVP) Module I. This guidance will be supplemented by the ‘Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders’, which will be published in due course.

Updated guidance on pharmacovigilance procedures

Detailed guidance on pharmacovigilance procedures from 1 January 2021 is published on the MHRA website: https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures-in-the-event-from-1-january-2021/updated-guidance-on-pharmacovigilance-procedures

Marketing Authorisations

New guidelines have been outlined for Marketing Authorisations, to include Conditional MAs, registering new packaging information, guidance on the handling of applications for Centrally Authorised Products (CAPs), Article 29 applications, converting parallel distribution notices to UK parallel import licences, handling of ASMFs and CoS from January 2021, reference medicinal products, converting CAPs to UK MAs, guidance on licencing biosimilars, bioequivalence/therapeutic equivalence studies and renewing marketing authorisations.

New Submission Registrations

For planned applications for submission to the UK (for example, a Marketing Authorisation for the UK market), you will need to submit the information through the MHRA national portals.

All current Eudravigilance Gateway users who wish to gain access to the new MHRA Gateway will need to first gain access to MHRA Submissions. The steps for gaining MHRA Gateway access are contained within MHRA Submissions. MHRA Submissions will not be used to send or receive ICSRs.

A useful webinar on how to gain access to MHRA submissions portal is available on the MHRA website at the following link https://www.gov.uk/government/publications/webinars-preparing-to-make-submissions-to-the-mhra-from-1-january-2021

Within the recent MHRA guidelines, the following areas are also covered:

Devices
Importing and Exporting
IT Systems
Paediatrics

IN DEPTH DETAILS ON THE NEW MHRA GUIDANCE CAN BE FOUND ON THE LINK BELOW:-

https://www.gov.uk/government/collections/mhra-post-transition-period-information

If you need any clarification or support to help you to navigate the end of transition period please contact us and Ivowen will gladly assist you in a timely manner.

Written by Mary Canning

Ivowen to attend EGA PV and RA conference – January 2016

26th January 2016

Ivowen will be attending the upcoming 9th EGA Pharmacovigliance, and the 15th EGA Regulatory and Scientific Affairs Conference in London from from 27th-29th January. Please contact us if you would like to arrange a meeting.

Pharmacovigilance most of all

23rd April 2020

The European Medicines Agency (EMA) has recently published an overview of pharmacovigilance activities that outlines just how strong and reliable a system we have in the EU. The report was prepared by EMA in collaboration with the National Competent Authorities (NCA). The report includes quantitative data covering the period between 2015 and 2018 and shows that the European regulatory network for medicines is held accountable for the implementation of the pharmacovigilance legislation.

The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017.

It shows that the EU pharmacovigilance system is strong and protects public health.

Some key outcomes 2015-2018

More than 500 new or updated risk management plans were assessed by the PRAC each year, ensuring the safety monitoring and risk minimisation is proportionate and planned. In addition, nearly 7,000 risk management plans were assessed by the Member States for nationally authorised medicines during the reporting period.
Enhanced EudraVigilance database of suspected side effects, resulting in improved reporting and greater analytical power;
Evaluation of nearly 9,000 potential signals (information about new or changing safety issues potentially caused by a medicine) by EMA’s signal management team over the period covered by the report, and a similar number of potential signals assessed by Member States;
Radical simplification and improvement of the way periodic safety update reports are handled, by establishing a common repository with a single portal for access;
Development of criteria to determine when a public hearing on issues of medicines’ safety would be of value, and the successful holding of the first such hearings, for valproate-containing medicines in 2017 and for quinolone and fluoroquinolone antibiotics in 2018;
Continued development of the ‘Article 57 database’, which now contains information on more than 800,000 medicinal products authorised through central, decentralised, mutual recognition and national procedures across the European Economic Area.

For more details on the report please refer to EMA web page where you can access the press release issued.

The pharmacovigilance legislation established now reinforces the need for and format of various reports, including:

Risk Management Plans (RMP);
Periodic Safety Update Reports (PSUR);
Post-Authorisation Safety and efficacy Studies (PASS);
Pharmacovigilance System Master Files (PSMF).

Should you require assistance with respect to setting up a pharmacovigilance system, or the preparation and submission of pharmacovigilance related data we encourage you to contact us.

Written by Alice D’Alton.

To 2019 and beyond (Brexit)…

4th December 2018

With the festive season upon us and 2019 on the horizon, Ivowen are setting our sights on the year ahead. So what’s going on in 2019 and beyond, including and excluding Brexit…

What’s happening in early 2019?

We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’.

Brexit follows quickly on the tail of the new year, and we will all be hopefully ready and able for this new challenge. Take our Brexit quiz here to see if you are Brexit ready and contact us to help.

What’s happening in later on in 2019?

We are also looking forward to attending the annual TOPRA symposium this year, hosted in Dublin, and we hope to see you at our stand to discuss how we can assist you with your regulatory needs in 2019 and beyond.

What about us?

Ivowen consists of an amazing team with extensive experience of the pharmaceutical industry. Our aim is to understand our customer’s needs and offer services that meet those needs in a timely and efficient way.
As part of EuDRAcon, a pan European network of regulatory consultants, we can provide expert advice on all matters regulatory for the EU and beyond, including Brexit

We hope that in 2019 Ivowen can help you with your specific and unique requests.

And for now…

The office will be closed from the afternoon of Friday 21st December 2018 until Wednesday 2nd January 2019. Merry Christmas and a Happy New Year for 2019!

For more information on Ivowen’s services and how we can help you, contact us