INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES Dr Dorcas Peta SAPRAA 6 March 2008

COMMENTS ON PI GUIDELINES PI Guideline for comment received May 2007 Comments deadline 1 August 2007 To date no response from MCC

COMMENTS ON PI GUIDELINES Delays in approval of PI updates remains a big concern for industry: Legal liability for PI without new information in SA when available in overseas PIs Guideline will help raise PIs to the same standard as overseas PIs

COMMENTS ON PI GUIDELINES Industry task force/Initiative 2008 Research based companies want to move issues forward at MCC Collaborative workshop on 13 March 2008 at PIASA offices by PIASA and IMSA groups Gathering of statistics for the past 5 yrs Data to be presented to Registrar, Clinical and Pharmacovigilance committees

COMMENTS ON PI GUIDELINES Industry task force/Initiative 2008 (cont) All benefit. Will have updated PIs quicker into market Generic companies will benefit from quick access to updated PIs Appeal for industry to support this initiative

COMMENTS ON PI GUIDELINES DETAIL OF COMMENTS/ INDUSTRY PROPOSALS

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