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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

INDUSTRY COMMENTS ON PACKAGE INSERTSGUIDELINES

Dr Dorcas Peta

SAPRAA 6 March 2008

comments on pi guidelines
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 guidelines1
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 guidelines2
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 guidelines3
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 guidelines4
COMMENTS ON PI GUIDELINES

DETAIL OF COMMENTS/

INDUSTRY PROPOSALS

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