New substances approved for listed medicines

Seven new substances have been approved for use in listed medicines so far in 2001, following an evaluation of their safety by the Complementary Medicines Evaluation Committee (CMEC) and publication of a notice in the Commonwealth of Australia Gazette.

Calcium lactate gluconate, thiamine phosphoric acid ester chloride, Streptococcus thermophilus, lycopene, Morinda citrifolia ('noni') fruit juice, Pseudowintera colorata ('New Zealand horopito') leaf and sugar cane wax alcohols are all now permitted for use in listed medicines. Listed goods containing sugar cane wax alcohols must carry a recommended daily dose of not more than 12 mg of this substance and must also carry the label statement 'not recommended for use by pregnant and lactating women'.

Sponsors should be aware that CMEC advised the TGA that, based on evidence obtained through the literature search strategy used, there does not appear to be any evidence to support indications relating Morinda citrifolia to immune support.

Herbal monographs and the British Pharmacopoeia

The BP2000 (British Pharmacopoeia 2000) contains a number of new herbal monographs that have been adopted from the European Pharmacopoeia. The Office of Complementary Medicines is currently reviewing the BP2000 to identify all those herbal substances with associated herbal monographs. Once this list has been completed it will be included on the TGA web site for reference.

OTC policy guidelines now updated

The 'Policy guidelines' chapter of the Australian Guidelines for the Registration of Drugs, Volume 2 (AGRD2), has been updated following extensive consultation with stakeholders and detailed consideration by the Medicines Evaluation Committee.

The new guidelines have been published as "Supplement 1" to the AGRD2. The supplement must be read in conjunction with AGRD2.

Features include new guidelines on aspirin, paracetamol and ibuprofen that were based on documents developed by the Australian Self Medication Industry (ASMI). Guidelines relating to products that are now regulated as complementary medicines have been removed.

As revision of the AGRD2 proceeds, further supplements will be published. The final document will be published on the TGA web site and will also be available for sale in hard copy as Australian Guidelines for the Registration of OTC Medicines (AGRM).

Outcomes from the 4th meeting of the Complementary Healthcare Consultative Forum

A full report of the fourth meeting of the Complementary Healthcare Consultative Forum (CHCF) is now available. Included in the items on the Forum's agenda were:

• discussions on the new advertising arrangements in place for complementary medicines and the supporting 'levels of evidence' framework;
• a look at the impact of the Internet on medicines advertising;
• the TGA's post market strategy for complementary medicines;
• an overview of the reforms in export arrangements for Australian medicines; and
• a look at the practical issues and regulatory challenges of the 'food/medicine' interface.

The Forum, which is chaired by Senator Tambling, was instituted as part of the reforms in complementary medicines introduced in 1999 and was established to facilitate consultation between government and the complementary healthcare sector. The Forum includes members from all mainland States and Territories of Australia and draws on a wide input from practitioner, research, consumer, educator, manufacturer, marketing and policy-making interests.

Amendments to TGA Approved Terminology for Medicines

The TGA maintains lists of Australian Approved Terminology to ensure accuracy and consistency in the information compiled in the Australian Register of Therapeutic Goods. For medicines, the lists cover substances (active ingredients and excipients), containers, dosage forms, routes of administration and units of expression and proportion. These lists are reproduced in the publication TGA Approved Terminology for Medicines - July 1999.

Amendments to this publication <http://www.tga.gov.au/docs/html/aan.htm> are now available and amendment updates will be published regularly on this page.

The amendments are available as one document or can be accessed as separate documents for each of the chemical, biological, herbal and other terms. Several new sections have been added to the publication to enable easier identification of changes that have been made to details relating to existing names (for example a change in PRV status).

The forms for proposing each new name type are also be available on the above web page. These forms should be printed, completed and returned to the TGA with supporting documentation, as there is no electronic lodgement system available yet for the approval of names.