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TMQA Regulatory News Update - September 2015

Download this month`s TMQA Regulatory News Update to find out more about:

  • MHRA Phase I Accreditation Scheme
  • EC Issues Consultation Document on Clinical Trial Inspector Expectations
  • EMA Begins its Full Medical Literature Monitoring Service
  • EMA Releases Revisions/Addendums to GVP Modules
  • HPRA Releases Annual Report 2014
  • EC, EMA and WHO Step up Cooperations to Better Protect Global Public Health
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EMA Begins its Full Medical Literature Monitoring Service

The EMA started its full medical literature monitoring service on 1 Sep 2015. This extended service is aimed to improve safety monitoring of medicines and simplify pharmacovigilance activities for companies. The implementation follows a launch period which began on 1 Jul 2015 and which included the 50 most common chemical active substance groups. A total of 400 active substance groups will now be monitored by the EMA and the service will benefit over 4000 companies. The list of active substance groups and a reference to the journals covered by the EMA’s medical literature monitoring service can be found on the monitoring of medical literature page of the EMA website. Companies are advised to check the list and see if their products are covered by this service. The EMA has sent updates on the implementation of its medical literature monitoring service to the qualified persons for pharmacovigilance in pharmaceutical companies as well as to pharmaceutical industry organisations.

MHRA Phase I Accreditation Scheme

The list of phase I units in the UK accredited by the MHRA was updated on 4 September 2015. There are currently 14 accredited phase I units in the UK. The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, particularly first in human trials. Organisations in the scheme have to exceed the basic regulatory good clinical practice standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.

EC, EMA and WHO Step up Cooperation to Better Protect Global Public Health

The EC and the EMA have agreed with the World Health Organisation (WHO) to share certain non-public information on the safety, quality and efficacy of medicines already authorised or under review in the European Union, or pre-qualified or under review by WHO. This cooperation will strengthen communication between the respective organisations and make it easier to protect public health. Under the confidentiality arrangement, the organisations involved may share information such as:

  • Post-authorisation pharmacovigilance data, particularly related to adverse drug reactions as well as safety concerns arising from periodic safety update reports, and post-authorisation obligations and commitments.
  • Information in applications for scientific advice, orphan medicine designation, marketing authorisation or post-authorisation activities of significant public health interest and applications for agreement of paediatric investigation plans.
  • Data related to inspections, manufacturing facilities and clinical research activities and related reports.

This cooperation between the organisations started on 01 September 2015.

TMQA exhibit at the BioCity Nottingham Lab Services Fair

Andrew and Adele attended the BioCity Nottingham Lab Services Fair today.   It was a great event with a real buzz and we met some really interesting companies.