If you are aware of any news items that would be of interest please contact the BARQA office.
SEPTEMBER 2010
JULY 2010
MHRA
Maintenance of Active Pharmaceutical Ingredient (API) and other sites named on marketing authorisations
MHRA
Good Laboratory Practice - Frequently asked questions
JUNE 2010
MHRA
Good Pharmacovigilance Practice Consultative Committee meeting minutes and questions and answers
MHRA
Pharmacovigilance inspection metrics report - July 2009 to March 2010
MAY 2010
MHRA
Updates to Good Pharmacovigilance Practice Section - Updates to FAQs
MHRA
Updates to Good Pharmacovigilance Practice Section - PV Inspection metrics
GMP - Annex 13 Revision
The long awaited revision to Annex 13 (Investigational Medicinal Products) of the EU Guidelines to Good Manufacturing Practice – Medicinal Products for Human and Veterinary Use was adopted by the Commission on 31st January 2010, published on 3rd February 2010 and comes into operation on 31st July 2010 and can be downloaded from: http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/2009_06_annex13.pdf
MARCH 2010
MHRA
Good Pharmacovigilance News
MHRA
New pharmaceutical industry area on MHRA website
FEBRUARY 2010
MHRA
Good Clinical Practice News
MHRA
Variations Regulation 2010 - New FAQs section
MHRA
Responses to MLX 363: MHRA regulatory fees for medicines - proposals for 1 April 2010
The European Medicines Agency Road Map to 2015
The European Medicines Agency has published a draft paper setting out its vision for the strategic development of the Agency for the five years to 2015. Building on the progress of its previous five-year strategy, the Road Map to 2015 charts the way forward for the Agency amid rapid developments in medical science and pharmaceutical research, as well as the continuing evolution of the european and international regulatory environments.
Click here to view the document
Please note the deadline for submitting comments is 30 April 2010
Please provide any comments by using this template
JANUARY 2010
MHRA
UK response to European Commission review of the Clinical Trials Directive
MHRA
Updates to Good Laboratory Practice section
JANUARY - DECEMBER 2009
EMEA
New visual identity
MHRA
Guidance published on UK national marketing authorisations (MA) variations
MHRA
Pharmacovigilance Expert Advisory Group summary minutes - 16 September 2009
MHRA
New MHRA online payment facility
MHRA
Guidance published on UK exporting of medicines
MHRA
Public consultation (MLX 360): Latent UK marketing authorisation (MA) applications
MHRA
Proposals for changes to regulatory fees from 1 April 2010
MHRA
New Risk-Based Inspection Programme for good inspections
Institute of Biology and BioSciences Federation unite to launch Society of Biology
5 October 2009
MHRA
Pharmacovigilance Expert Advisory Group summary minutes - 11 March 2009
18 September 2009
MHRA
Good Pharmacovigilance Practice News
8 September 2009
MHRA
Good Clinical Practice News
24 August 2009
MHRA
Directives Bulletin 17 -Medical Devices and Medicinal Products
MHRA
List of new Manufacturing and Wholesale Dealer Licences - July 2009
6 August 2009
Accreditation
A briefing for Government and Regulators from the European co-operation for Accreditation
European co-operation for Accreditation website
MHRA
Guidance Note 3 - Information for Clinical Investigators
27 July 2009
MHRA
Good Clinical Practice News
24 July 2009
MHRA
What's new in GLP
22 July 2009
Andrew Gray of the MHRA to join Vanessa Grant and Tim Stiles on the tutor group for our Implementing Good Clinical Laboratory Practice professional development training course
on 17th - 18th September 2009
MHRA
Good Pharmacovigilance news
17 July 2009
MHRA
Whats new in GLP
17 July 2009
MHRA
Adverse drug reaction (ADR) reports received by the MHRA from literature articles
16 July 2009
MHRA
What's new in GLP
30 June 2009
MHRA
Good Clinical Practice news
29 June 2006
MHRA
The guidance on writing patient information leaflets
29 June 2009
MHRA
What's new in GLP
23 June 2009
MHRA
Good Clinical Practice News
12 June 2009
Special Mail 5: Frequently asked questions Version 2.1 (June 2009)
10 June 2009
MHRA
Public consultation (MLX358): The European Commission proposals on information to patients for prescription medicines - 21 May 2009
Marketing Authorisations granted in April 2009 - 21 May 2009
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