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Recent News

If you are aware of any news items that would be of interest to the RQA membership, please contact the RQA office.

MHRA Business Plan for 2014-15

16th April 2014

The MHRA has published its Business Plan for 2014-15. This is an important document that sets out key work over the next year to progress their 2013-18 Corporate Plan and how they will respond to challenges and opportunities ahead.

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MHRA - Managing Medical Devices

14th April 2014

Guidance on managing reusable medical devices in hospitals and community based organisations

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EU Statement on Clinical Trials Regulation

2nd April 2014

Statement by Health Commissioner Tonio Borg following the vote in Parliament on the Clinical Trials regulation

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GCP Inspection Report Metrics

25th March 2014

MHRA Report covering the period 1 April 2011 to 31 March 2012 has been added to the Good Clinical Practice section

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MHRA and NHS England in initiative to simplify adverse incident reporting

25th March 2014

MHRA and NHS England have jointly issued two patient safety alerts and supporting guidance to help simplify reporting and help healthcare providers increase incident reporting involving medication errors and medical devices.

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MHRA - GCP Inspections Report

18th March 2014

GCP Inspections Metrics Report covering the period 1 April 2010 - 31 March 2011

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New career opportunity on website - QRC Consultants

17th March 2014

A new career opportunity has just been added to the website - GCP QA Consultant at QRC Consultants

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New career opportunity on Website - Bourn Hall Clinic

27th February 2014

Senior Quality Assurance Auditor and Quality Assurance Auditor - Bourn Hall Clinic near Cambridge

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EudraGMDP improves visibility of compliance

20th February 2014

Following the launch of EudraGMDP V5.1, GMP non-compliance statements can now be viewed by the public.

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MHRA new Clinical Director of Medical Devices

11th February 2014

The MHRA today announced that Dr Neil McGuire has been appointed as its new Clinical Director of Medical Devices with effect from 3rd March 2014

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EU Clinical Trial Regulation - NEW Webinar from RQA

10th February 2014

A new webinar from RQA is now available to purchase online. EU Clinical Trial Regulation: Where are we? The RQA GCP Committee offers a 'heads up' on some of the GCP aspects of the proposed Regulation (draft 20th December 2013). Some have heralded it as the biggest change to Clinical Trials since the EU Clinical Trials Directive (2001/20/EC). The EU is dramatically changing the law regarding clinical trials and plans to repeal the existing EU Directive 2001/20/EC.

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Revision of European Commission Guidelines on Good Manufacturing Practice for Medicinal Products

10th February 2014

The European Commission have launched the Public Consultation on the revision of Annex 15: Qualification and Validation. Stakeholders are invited to comment on this draft by 31st May 2014 at the latest

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New and revised Draft Guidances CDER is planning to publish during 2014

6th February 2014

CDER draft Guidances planned for 2014

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Good Pharmacovigilance Practice compliance report template now available

4th February 2014

MHRA - The risk-based inspection compliance report 2013 for Good Pharmacovigilance Practice is now available.

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EU Clinical Trial Regulation - Webinar from RQA

3rd February 2014

A new webinar from RQA is now available to purchase online. EU Clinical Trial Regulation: Where are we? The RQA GCP Committee offers a 'heads up' on some of the GCP aspects of the proposed Regulation (draft 20th December 2013). Some have heralded it as the biggest change to Clinical Trials since the EU Clinical Trials Directive (2001/20/EC). The EU is dramatically changing the law regarding clinical trials and plans to repeal the existing EU Directive 2001/20/EC.

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Regulatory Guidelines for Medicinal Products for Veterinary Use Volume 6B - Presentation and Content of the Dossier - January 2014

28th January 2014

Volume 6B gives guidance to applicants for marketing authorisations for veterinary medicinal products on the presentation of the data requirements and summaries of the dossier

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Bioresearch Monitoring (BIMO) metrics 2013

27th January 2014

Bioresearch Monitoring (BIMO) metrics for 2013 now available

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Q&A: Article 31 Pharmacovigilance referral

27th January 2014

This guidance addresses a number of questions which stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 31 referral resulting from the evaluation of data from pharmacovigilance activities.

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EMA - Good Pharmacovigilance Practice Annex 1 Revision 2 Definitions

13th January 2014

European Medicines Agency Good Pharmacovigilance Practice Annex 1 Revision 2 Definitions came into effect on 8 January 2014

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Draft Guidelines on Audio-Visual Recording of Informed Consent Process in Clinical Trial - India

10th January 2014

Draft Guidelines issued by Central Drugs Standard Control Organization (CDSCO), India on audio-visual recording of informed consent process in clinical trial - 9th January 2014

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Reflection paper on risk based quality management in clinical trials

24th December 2013

Reflection paper on risk based quality management in clinical trials adopted with effective date of 18 December 2013

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Reflection paper on the use of interactive response technologies in clinical trials

24th December 2013

Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates. Effective date 22 November 2013

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December 2013 GCP Legislative Update

23rd December 2013

December 2013 GCP Legislative Update available now

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New 'Orange Guide' available January 2014

19th December 2013

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2014 - the 'Orange Guide' The eighth edition of this guide compiled by the MHRA is an essential reference for all manufacturers and distributors of medicines in Europe, This latest edition is available from 2 January 2014

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Senior GCP/PV Auditor - Roche

18th December 2013

New recruitment opportunity just added to the website

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Medicines Regulatory News: New Drug Driving Offence - Implications for medicines packaging

13th December 2013

A new drug driving offence will come into effect in the summer of 2014. The MHRA has written to marketing authorisation holders about the impact of this change of legislation on the packaging requirements for medicines.

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Updates to Good Distribution Practice Guidelines

13th December 2013

An updated version of the revised Good Distribution Practice guidelines has been issued by the European Commission

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New job opportunity added

11th December 2013

Pharmacovigilance Auditor, Boehringer Ingelheim- Bracknell, Berkshire/Ingelheim, Germany

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MHRA Starts work to improve EU Pharmacovigilance capabilities

28th November 2013

The MHRA is coordinating a three year EU-wide pharmacovigilance project to help member states meet the requirements of the new pharmacovigilance legislation.

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EMA - Reporting requirements of ICSRs

11th November 2013

European Medicines Agency - Reporting requirements of ICSRs applicable to marketing authorisation holders during the interim period

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MHRA Perception Survey

11th November 2013

MHRA survey: Participate in the MHRA 'Perception Audit 2013' research. The MHRA is conducting a survey to find out what you think about their services and products

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MHRA Makes changes to the clinical trials Phase 1 Accreditation Scheme

4th November 2013

The MHRA and associated key stakeholders have recently undertaken a detailed review of the scheme and identified a number of aspects that required revision. The update to the scheme is implem,ented from 31 October 2013.

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MHRA now updated: Serious breaches of Good Clinical Practice reporting

4th November 2013

MHRA have updated Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol (Version 4)

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European Medicines Agency launches a new version of EudraCT

31st October 2013

Summary results of clinical trials soon to be available to the public The EMA has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V9, marks the initial step of a process through which summary clinical trial results will be made publically available through the EU Clinical Trials Register (EU CTR).

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RQA Education and Training Manager

24th October 2013

A great new opportunity is now available at the RQA.

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Declaration of Helsinki 2013

22nd October 2013

The Declaration of Helsinki is the WMA's best known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembley in October 2013. The current version (2013) version is the only official one: All previous versions have been replaced and should not be used or cited except for historical purposes

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