Responses to Section 31 requests for information from sponsors

It has become quite a time consuming task for Drug Safety and Evaluation Branch (DSEB) staff to identify and determine if the data provided as a response under Section 31 of the Therapeutic Goods Act requires payment of additional evaluation fees. To expedite the processing of your S.31 response with data, please ensure that the following steps are taken:

• quote the S.31 number;
• ensure that the S.31 response has clear and consistent pagination;
• bind and label responses which exceed ten pages;
• label each volume/section of data by drug name, sponsor name, part and page range; and
• ensure that parts of more than one volume are coherently paginated.

Also, a reminder about binders and packing:

• binders should allow the document to stay open on a desk to facilitate the evaluator's work (two, three or four ring or lever arch binders are suitable);
• external dimensions should not exceed 290 mm x 370 mm and 80 mm in thickness;
• each binder, where possible, should contain one volume of data; and
• binders must be laid flat within the carton to prevent contents forcing binders open - a tie or piece of elastic around the binders also keeps the contents intact.

Literature based submissions: points to consider

The final version of the document, Literature Based Submissions: Points to Consider, is now available from the DSEB. The Branch has also decided to run the first training workshop/seminar for industry as listed in the TGA Commercial information kit. This seminar will review two issues - the reporting of adverse reactions in product information documents and bibliographic submissions.

The seminar will be held on 21 November 1995 at Symonston and is designed to be an interactive workshop so that related issues can be discussed. As this seminar has been fully booked, a second seminar will be held on 6 February 1996 - venue to be confirmed.

APMA/TGA CPI workshop: shared experiences

On 28 July 1995, a small group of representatives from the Australian Pharmaceutical Manufacturers Association (APMA) joined representatives of the TGA for a workshop to share experiences about the development of Consumer Product Information (CPI).

The DSEB review process for CPIs was discussed. The minimum standard of CPI evaluation includes a check that the CPI is consistent with the approved Product Information (PI) and that it includes the information referred to in Schedule 12 to the Therapeutic Goods Regulations.

The activities undertaken by the pharmaceutical industry in order to produce CPI documents of a high standard, which includes comprehensive information for consumers, were discussed in detail at the meeting.

With funding from the Department of Health and Family Services's Pharmaceutical Education Program, the Communication Research Institute of Australia (CRIA) has produced usability guidelines for the writers of CPI documents. The usability guidelines describe ways to communicate information about medicines in a CPI and a method for diagnostic testing of CPI documents with consumers. Industry speakers explained how the testing methodology is being used by pharmaceutical companies in the development of CPIs.

Recognising the need for consistency between CPIs for products in the same therapeutic class, to minimise the potential for confusion if a consumer's therapy is changed to a different product to treat the same condition, the APMA has initiated CPI consistency working groups. Core CPI documents have been prepared for antianginal products, drugs to treat hyperacidity, reflux and ulcers, and benzodiazepines. Working groups are also developing core CPIs for antidepressants and drugs to treat hypercholesterolaemia, with groups planned in other classes.

A CPI Content/Quality Assurance Reference Group (QARG) has been established under the auspices of APAC and PHARM. The Reference Group has representatives from CRIA, consumers, doctors, nurses, pharmacists, and industry and clinical pharmacologists. Its primary role is promoting high quality, useful Consumer Product Information for pharmaceuticals and overseeing the activities of the CPI consistency working groups.

Update to TGA Guidelines on the Reporting of Adverse Drug Reactions by Drug Sponsors

In response to recent international initiatives, the TGA will update the definition for "unexpected" adverse reactions in its Guidelines on the Reporting of Adverse Drug Reactions by Drug Sponsors.

The wording of the current definition will not be altered, but will be clarified by an additional clause relating to reactions with no established causal relationship. This change has been prompted by the recent release of the Guidelines for Preparing Core Clinical-Safety Information on Drugs prepared by the third Working Group of the Council for International Organisations of Medical Sciences (CIOMS III). The revised Australian wording, which will appear in future editions of the Australian Guidelines on the Registration of Drugs (AGRD), will now read:

"Unexpected reaction - An adverse reaction that is not identified in nature, severity or frequency in the current Australian product information or investigator brochure (or in the risk information described in the general investigational plan), or that is NOT expected from characteristics of the drug. Furthermore, adverse reactions which currently appear in the Australian product information but are described as having no established causal relationship should be considered 'unexpected' for the purposes of reporting to the TGA."

Exchanging Part II Evaluations with New Zealand

Following discussions with the New Zealand Therapeutics Section, the TGA will advance Trans-Tasman harmonisation by exchanging Part II evaluations with New Zealand.

This process will be facilitated if companies, whenever possible, (a) submit Part II data concurrently in Australia and New Zealand and (b) submit the same data. Because both agencies accept data in European format, it is possible to submit exactly the same Part II package. The covering letter to applications in both countries should state that the Part II data are identical and should explicitly give permission to exchange evaluations.

If applications cannot be exactly concurrent, advance notice of the timing would be helpful. If the Part II data are not identical, the differences should be listed.

This option does not currently apply to biologicals or antibiotics.