The document is intended to give guidance to applicants in making applications for clinical trials on medicinal products for human use to the Irish Medicines Board (IMB) as competent authority for these Regulations. To read the guide, click on the link : http://www.imb.ie/3876.htm.
Significant changes have been made to the guidance for the use of non-GLP facilities from the MHRA. The document can be found at: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON137893
This consultation seeks views on proposals to change the levels of fees charged by the MHRA for the regulation of medicines, including herbal and homeopathic medicines, and blood establishments and blood banks. In summary it aims to:
Further information can be found at: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&ssDocName=CON137905
The US (FDA) has raised some concerns, following its inspection of Cetero Research facilities in Houston (Texas), about the conduct of bio-analytical studies in the period April 2005-June 2010, and has notified pharmaceutical companies that bio-analytical studies conducted by Cetero Research in that period in support of marketing authorisation applications may need to be repeated or confirmed.
The Member States and EMA are undertaking a process to identify all medicinal product dossiers, approved or pending approval, that include studies conducted at the above mentioned facility.
All MAHs and Applicants are requested to provide information on whether the analytical laboratory testing in any of their dossiers was conducted at the CRO Cetero Research Houston, Texas in the defined period.
The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure.
The new rules will apply to all type IA variation notifications for both human and veterinary medicines.
The Agency will charge the fee at the start of the procedure, irrespective of the final opinion. All variations in a grouped IA application will be charged irrespective of whether there is a full or partial negative outcome.
The applicable type IA fee will still be charged for applications that are withdrawn after the start of the procedure.
The start of procedure is defined as the date of the notification from the marketing-authorisation holder.
The Agency will continue to charge for type IA variations that are grouped with other variations or extensions or are part of worksharing procedures on conclusion of the validation of the application. The current rules for charging of fees will continue to apply.
The European Medicines Agency has invited pharmaceutical companies to register to take part in a three-month pilot of its eSubmission Gateway , beginning on 9 January 2012.
The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralised marketing authorisations for human medicines in the Electronic Common Technical Document (eCTD) format. This includes new applications, supplementary information, variations and renewals of marketing authorisation.
Link
The document offers guidance to aid start-up cosmetic manufacturers understand their obligations as described in Cosmetics Directive 76/768/EEC (as amended) and transposed in Ireland by the European Communities (Cosmetic Products) Regulations, S.I. No. 870 of 2004 (as amended). This document also serves to prepare the intended user for the upcoming changes in legislation, due to Regulation (EC) 1223/2009 which comes into effect in July 2013.
Link
On 29th september 2011. The purpose of this document is to provide guidance on the regulations covering the wholesale distribution of medicinal products for human use in Ireland.
Link
http://www.imb.ie/images/uploaded/documents/IA-G0008%20Guide%20to%20wholesaling%20of%20medicinal%20products%20for%20human%20use%20in%20Ireland%20v1.pdf
In 2006, the European Commission initiated an ambitious project to revise the overall framework for variations to make the whole system simpler, clearer and more flexible without compromising public health.
The new regulatory framework on variations is the Commission’s main contribution to the ‘Better Regulation’ policy agenda in the field of pharmaceuticals.
The final step to conclude the adoption of the variations’ initiative will be the amendment of Regulation (EC) No 1234/2008 to enlarge its scope to include purely national authorisations, in accordance with the mandate given by Directive 2009/53/EC.
Link:
http://ec.europa.eu/health/documents/new_en.htm
On 31st August 2011, Argentina became a full adherent to the Organisation of economic co-operation and development (OECD) Council ACTS relating to the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals and joined that part of the Chemicals Programme related to MAD, with all the rights and obligations of member countries.
Link:
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodLaboratoryPractice/Newsandhottopics/CON129151
