Since it started in 1999, NICE’s technology appraisals have reached over 80% approval of drugs (including recommended and optimised) and 6% of treatments have been approved for research only.  The recommendations are based on the effectiveness of the treatment compared with competitors treatments already available on the NHS.

Marketing authorisation holders for medicines for which the marketing authorisation  was  granted before 30 October 2005 had a 5 years transitional period to amend the labelling to comply with Articles 54(a), 54(e) and 56(a). The MHRA has reminded MAHs to submit their applications by the 1 August 2010 to ensure compliance  by 30 October 2010.

The new requirements to comply with the above articles are:

• displaying the common names of the active substances clearly on the packaging
• including a space for the prescribed dose to be indicated
• displaying the name registered in section 1 of the SmPC in braille on the packaging

The MHRA has reminded marketing and manufacturing authorisation holders to keep all API manufaturing sites named on approved marketing authorisations actively maintained as approved suppliers in line with European GMP expectations. If  Companies do not want to maintain back up API manufacturers to GMP requeirement, they should remove them from the MA by submission of a Type A variation.

The applications under Article 61(3) are notifications regarding minor changes to the label and the PL, that are not associated with a change to the SmPC, and are not subject to the variation application.

However, submission of the results of user testing is considered outside the scope of the article 61(3) notification procedure. This includes situations where the results of user testing do not lead to a change, or minor changes, to the product information. The recommendation is to submit a Type IB variation procedure under catefory C.I.Z., to comply with Article 59(3) of Directive 2001/83/EC.

[caption id="attachment_352" align="aligncenter" width="300" caption="Zimna during the Race"][/caption]

The female staff at Cambridge Regulatory Services raised money for Breast Cancer UK. Karen James (Managing Director), Lisa Tietjen (Executive Director) and Zimna Wazeer (Project Manager) ran 5 km around Parkers Piece in Cambridge for the Race for Life event on the 4th July 2010.

The requirements on electronic submissions (NeeS and eCTD) and paper documentation have been updated on the CMDh website. Most NCAs are ready to receive electronic-only documentation and this mode of submission is strongly promoted even when the NCA still accepts paper submissions. No NCA request full paper copy anymore, however some modules might be required in paper beside the full electronic dossier. The dossier requirements are summarised in three tables on the CMDh website: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/eSubmissions/CMDh-085-2008-Rev6.1.pdf”

An updated list of contact email addresses for submision of electronic response documents for applications for marketing authorisations, variations and renewals in mutual recognition procedures and DCP is available on the CMDh website.

The MHRA is collating examples of best practice in patient information design. We are pleased to anounce that one of the Patient Information Leaflets tested by Cambreg has been nominated as PIL of the month by the MHRA. Congratulations to our Clients and to the Cambreg team.

The CMDh has issued a revised version of the best practice guide on the uses of eCTD in Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP). The guide supports applicants in meeting the legal obligations within the MRP and DCP in eCTD format.

The draft of Guideline on Detection and Management of Duplicate Individual Cases and Individual Safety Reports (ICSRs) was released by the EMA for consultation today, 29th June 2010. The consultation period will end on 29th September 2010 and the guideline will be implemented.