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INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES

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.

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INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES

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  1. INDUSTRY COMMENTS ON PACKAGE INSERTSGUIDELINES Dr Dorcas Peta SAPRAA 6 March 2008

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

  3. 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

  4. 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

  5. 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

  6. COMMENTS ON PI GUIDELINES DETAIL OF COMMENTS/ INDUSTRY PROPOSALS

  7. THANK YOU

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