Advances in biotechnology and the mapping of the human genome have created opportunities that appears to be limited only by man''s imagination.

The emergency of recombinant engineering over twenty years ago is now a mature technology and "biogenerics" are appearing. Man''s knowledge of the genome and how it affects disease and the response to treatment will make it possible to screen for, diagnose, and treat disease with unprecedented speed and accuracy in the foreseeable future.

Most small drug regulatory authorities will have to work very hard to keep up with the challenge of ensuring that these products are safe and effective. The challenges will include:

- Bio-equivalence of biotechnology products - will this be a barrier to biogenerics?

- Quality assurance of biological products - How many national laboratories will have the expertise for this?

- Revolutionary techniques to identify new compounds and revisiting the Pharmacogenomics of old products

- Blurring of the boundaries between drug and device.

- Post marketing surveillance - Likely to see fewer and fewer patients exposed to the drugs prior to product launch. PMS systems will have to be in place, robust and truly global.

- Ethical considerations - An array of dilemmas are unlikely to have been resolved before the first products come for approval and include consequences of genomic screening, confidentiality of data and affordable access to these products in developing countries.

- As the pharmaceutical industry gears up to apply genomics to drug development there is likely to be a short term drought of new products followed by unprecedented pressure to bring the revolutionary products to market. Regulatory affairs staff must start their preparations now and must develop the knowledge and skills to be able to face these challenges with confidence.

- The author is an advisor at the UAE, Ministry of Health.