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. http://tinyurl.com/qfb62ol
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. http://tinyurl.com/ngmwhcf
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.
Scotland's First Minister announces new enterprise area at BioCity Scotland
Scotland’s latest proposed Enterprise Area – the BioCity industrial tech incubator – could see employment boosted by another 180 new jobs in the next five years. Read more at http://www.biocity.co.uk/news/scotland/2015/first-minister-announces-new-enterprise-area-at-biocity-scotland
TMQA Regulatory News Update - August 2015
Download this month`s TMQA Regulatory News Update to find out more about:
- MHRA GPvP Inspections of Contract Service Providers
- Draft Addendum to ICH E6 Released
- EMA launches pilot in relation to Post-Authorisation Safety Studies
- MHRA enforces EC decision in relation to GVK Biosciences
- EMA revises guidelines on implementation of fast track routes for medicines that address unmet medical needs