Monthly Archives: %sAugust 2014

What guides the development of new medicines?

From a regulatory point-of-view the pivotal guidance documents for the development of medicines are whose of the International Conference on Harmonisation (ICH). These guidelines are usually adopted by other regulatory agencies such as European Medicines Agency (EMA) and Therapeutic Goods Administration (TGA); thus guidance documents are also found on country specific regulatory website. Whatever […]

By |August 31st, 2014|Drug Development|0 Comments

International Conference on Harmonization (ICH): A global collaboration

No discussion of the regulation and development of medicinal products is complete without mentioning the critical role of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Prior to 1990, the technical requirements for registration of drugs were significantly different between the three major pharmaceutical jurisdictions – namely […]

By |August 30th, 2014|Drug Development, Drug Regulation|0 Comments

Does the benefit of the medicine outweigh the risk?

It was only after I started working in drug regulation that I fully appreciated the role of risk/benefit analysis for medicines. I thinks it’s a testimony to the skill of the regulators that balancing the benefit of a medicine against the risk has been performed so well that, as a consumer, I expected any […]

By |August 29th, 2014|Uncategorized|0 Comments

What’s required to register a prescription medicine?

This is a helicopter view of the regulatory requirements to gain approval for a prescription medicine in Australia. For detailed information it’s best to refer to the Therapeutic Goods Administration (TGA) website.

In order to be able to sell a therapeutic good in Australia it’s necessary to have the product included on the Australian Register […]

By |August 28th, 2014|Drug Regulation|0 Comments

Why medicines are so highly regulated

You may have wondered why it takes so long to develop a new medicine and why there is such a high level of regulation.

This has come about for two main reasons: historically there have been some significant mistakes which have resulted in a serious injury and on occasions even resulted in death. Whenever this […]

By |August 27th, 2014|Drug Regulation|0 Comments