1. 1 FEEDBACK ON MCC PROJECT MEETING HELD ON 14 MAY 2010 Dr Dorcas Peta 4 JUNE 2010

2. 2 Objectives of this Presentation FEEDBACK ON THE FOLLOWING ISSUES: Project Management Team Backlog Project Communication with MRA Introduction to SAHPRA MRA and SAHPRA fee structure MRA communication with Industry SAHPRA communication with Industry Additional items raised

3. 3 Project Management Team (PMT) Dr Nicholas Crisp – Project Leader Dr Johan van Heerden Carol Fries Dr Joey Gouws – Deputy Registrar Dr Sybil Seoka – Deputy Registrar Other MRA Staff Consultants

4. 4 Backlog Project Consultants worked with MRA staff Audit conducted and inventory list created Industry assisted with audit from their side Backlog cleared???? Suggestion to conduct audit with industry on Clinical Trials and Amendments Backlog project end date 30 June 2010 How to prevent a repeat????

5. 5 Communication with MRA PMT Received questions from associations Questions related to SAHPRA or both SAHPRA and MRA were addressed MRA specific questions referred to Registrar e.g. - CTD and eCTD guidelines - Implementation of safety update guidelines - Finalisation of CAMS regulations - SACRA request for MCC workshop

6. 6 Introduction to SAHPRA Act 72 of 2008 signed but never promulgated Abolishes MCC and creates SAHPRA Covers products and medical devices Minister appointed Dr Crisp as project leader to create public entity SAHPRA to operate from Civitas

7. 7 Introduction to SAHPRA continued Principal Project Team members: Dr Nicholas Crisp Dr Johan van Heerden Carol Fries Elsabe Klinck Others: Finance, HR, Communication, IT, Labour relation etc Timeline to implement new RA is Dec 2011

8. 8 MRA and SAHPRA Fee Structure Need for staged increase of fees Current fee structure assessed Industry budget planning taken into consideration PMT to engage with industry on proposed fees by 20 July 2010 Devices to be discussed separately

9. 9 MRA Communication with Industry Industry Task Group (ITG) revitalised Structured communication framework Joint letter to Registrar

10. 10 SAHPRA Communication with Industry SAHPRA PWG main contact point Establishment of sub working groups Communication will be transparent and inclusive MRA specific issues to the Registrar PMT to set agendas for meetings 2 Reps per organisation on PWG Meetings planned for July, Sept and Nov

11. 11 Additional items raised Veterinary Regulatory Authority Consumer Protection Act MRA move to Civitas EDMS MRA Website ITG

12. 12 THANK YOU