Important interim changes to the guidelines on the reporting of adverse drug reactions by drug sponsors

We wish to notify the sector of the pharmaceutical industry marketing registered drug products regulated by the Drug Safety and Evaluation Branch ("DSEB regulated registered drug products") in Australia of some important changes effective immediately to the Guidelines on the Reporting of Adverse Drug Reactions by Drug Sponsors, Appendix 20, Australian Guidelines for the Registration of Drugs Vol.1, July 1994.

In brief, these proposals are

1. to change the time requirement for the reporting of serious suspected adverse reactions (expedited reports) to "immediately and in no case later than 15 calendar days of receipt" and
2. with respect to non-serious reactions whether expected or unexpected to remove the requirement for sponsors to report as individual case reports. Instead, sponsors should report such suspected adverse reactions on request or as line listings in a Periodic Safety Update Report. Both proposals would make Australian requirements consistent with those of the European Pharmacovigilance Guidelines CPMP/PhVWP/108/99 corr.

DSEB adopts two pivotal European guidelines

The Drug Safety and Evaluation Branch (DSEB) has adopted, in principle, two European guidelines which have a major bearing on the use of unapproved medicines in Australia.

The first of these is the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), an internationally accepted standard for the design, conduct, recording and reporting of clinical trials. This document, and the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans, 1999 (the Australian ethical standard for research involving humans), now represent the standard for the conduct of clinical trials in Australia. These guidelines replace the Guidelines for Good Clinical Research Practice (GCRP) in Australia, December 1991, DEB 3.

The second guideline adopted is the Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95). This is an internationally accepted standard for the reporting of important clinical safety information principally arising during the clinical development of medicines. The definitions and time frames for reporting of adverse drug reactions (ADRs) adopted by DSEB will apply to all use of unapproved medicines, including clinical trials and use of products under the Special Access Scheme by Authorised Prescribers and through personal importation.

Both CPMP documents acknowledge that, for some issues, national legal requirements and the requirements of individual regulatory agencies may vary because of differences in local conditions and culture. In Australia, section 3 of the GCP Guidelines which relates to ethics committees is, by necessity, overridden by the NHMRC National Statement on Ethical Conduct in Research Involving Humans, 1999. Thus, DSEB has not adopted this section of the GCP Guidelines. To assist users to identify those sections not adopted by TGA and those sections requiring further explanation of Australian regulatory requirements, DSEB has reproduced and annotated both CPMP documents as follows:

• Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), (annotated with TGA Comments, DSEB, July 2000) <http://www.tga.gov.au/docs/html/ich13595.htm>; and
• Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95), (annotated with TGA Comments, DSEB, July 2000) <http://www.tga.gov.au/docs/html/ich37795.htm>.

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European Union guidelines

Following consultation between the Drug Safety and Evaluation Branch (DSEB), the TGA Laboratories Branch (TGAL) and the Australian Pharmaceutical Manufacturers Association (APMA), it has been decided that the following European Union (EU) Guidelines should be published as adopted in Australia. The EU Guidelines are generated by the Committee for Proprietary Medicinal Products/International Conference on Harmonisation (CPMP/ICH) and are to be regarded as part of Volume 1 of the Australian Guidelines for the Registration of Drugs (AGRD). The guidelines included in this edition of TGA News will also be included in the next edition of Volume 1 of the AGRD.

These Guidelines were adopted with effect from 1 August 2000.

Guidelines to be adopted in Australia:

Ref. No. CPMP/EWP/281/96
Note for Guidance on Clinical Drugs Used in Weight Control.

Ref. No. CPMP/ICH/135/95
Note for Guidance on Good Clinical Practice This guideline is adopted with some modification: see previous article.

Ref. No. CPMP/ICH/377/95
Note for Guidance on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting This guideline is adopted with some modification: see previous article.

Complete list of all the guidelines published as adopted in Australia <http://www.tga.gov.au/docs/html/euguidead.htm>.

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TGA Clinical Evaluation Sections October 2000

Clinical Evaluation Section 1

Dr Neil Mitchell (Head)
Jovi Bacud (Senior Pharmacist)

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Clinical Evaluation Section 2

Dr Grahame Dickson (Head)
Elaine Cain (Senior Pharmacist)

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Clinical Evaluation Section 3

Dr Phillip Chipman (Head)
Michael Bateman (Senior Pharmacist)

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Clinical Evaluation Section 4

Dr James McGinness (Head)
Aruna Raniga (Senior Pharmacist)

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Clinical Evaluation Section 5

Dr Christine Anantharajah (A/g Head)
John Irzykiewicz (Senior Pharmacist)