amanda-merrill
Uploaded by
7 SLIDES
197 VUES
70LIKES

INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES

DESCRIPTION

This document outlines the comments and feedback on Package Insert (PI) Guidelines submitted by Dr. Dorcas Peta for SAPRAA on 6 March 2008. It discusses the industry's concerns regarding delays in PI approvals, legal liabilities for outdated information, and the need for aligning local PIs with international standards. The document highlights a collaborative workshop held on 13 March 2008 and the importance of timely updates for PIs to benefit both research-based and generic companies. The industry's initiative aims to expedite the process for better market access.

1 / 7

Télécharger la présentation

INDUSTRY COMMENTS ON PACKAGE INSERTS GUIDELINES

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related