- PDF Version (138K) - Print Friendly - Help

AgVetLink: Number 52, October 2005

12th Royal Australian Chemical Institute Convention

This convention in Sydney, which was attended by Warren Tully, Senior Advisor (Chemicals), occurs every five years. This year it had up to 12 seminars running simultaneously, so there was a smorgasbord of choice. The seminars most relevant to ACVM included:

Chemical challenges in developing pharmaceutical products for the 21st century

Recent recalls of pharmaceuticals have led to widespread debate in the media about the effectiveness of regulatory agencies in approving safe medicines to be marketed. The rapid advances in analytical technologies have led to characterisation and quantification of active ingredients, impurities and metabolites in minute amounts. This raises such questions as:

• Has this led to much safer and efficacious medicines?

• How important is it to get all the impurities measured and to minute quantities?

• What are the risks associated with allowing the release of a product that is 9.9 % below the active claim and not releasing one at 10.1% below the active claim?

Efficacy and safety problems often arise because the trials are not able to reflect all the different situations in which the products will be used, e.g. they cannot take into account all the medical, genetic or exposure histories of potential patients.

Regulation of agricultural and veterinary chemicals: current challenges and priorities

• Is compliance too much focused on low risk products? This may be important commercially but is not risk-based.

• Applicants, not regulators, must prove products are safe.

• The importance of interface with other national regulators to provide international consistency was stressed.

BP/EP/USP – What’s the difference?

The British Pharmacopoeia (BP) used to be the official standard for Australia’s Therapeutic Goods Administration (TGA). All therapeutic goods (ingredients and formulated products) must meet the pharmacopoeia requirements. Currently, exemptions from BP are by application to TGA.

What the official standard for medicines in New Zealand and Australia will be is under review. How will the TGA decide what to adopt?

Information of note:

1. By law, BP incorporates the European Pharmacopoeia (EP); therefore BP is EP + some extras.

2. The correct term for USP is ‘USP-NF’ (United States Pharmacopeia – National Formulary).

3. BP generally has tighter and more comprehensive specifications than USP-NF.

4. USP-NF has wider coverage.

5. USP-NF is not as active at updating older monographs.

6. USP-NF is more active at updating general methods.

7. BP monographs on dosage forms whereas EP is on ingredients.

Another seminar of note was Chemical Regulation in Australia: An Historical Perspective. Historical examples such as arsenic in beer via cheap methods of production make us lucky we now have a better regulatory system than days past.