1. INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES
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