The variety and size of pharmaceutical activities in a country determine the type and burden of responsibility which the DRA must bear. Figures 3.4a and 3.4b indicate the size of the pharmaceutical sector in the 10 countries, while Figure 3.5 shows the number of registered products in each country.

From Figure 3.4a it is clear that Australia has a large number of manufacturers to regulate, as do Malaysia and the Netherlands. This means that these countries will require a larger number of GMP inspectors compared with Cyprus, Estonia and Uganda, countries with a relatively smaller domestic manufacturing industry.

Figure 3.4b, on the other hand, shows that the total number of drug suppliers (importers and wholesalers) and retail outlets to be regulated are higher in Malaysia and Venezuela, followed by Australia, than in countries such as Cyprus, Estonia, Uganda and Zimbabwe.

This means that Australia, Malaysia and Venezuela have to invest significant human and financial resources in inspections of the supply channels in their respective countries in order to ensure compliance with the requirements of good distribution practice (GDP) and the provisions of the pharmaceutical laws. Arranging human resources and schedules for inspection is even more arduous when the distribution outlets are widely dispersed through the rural areas.

Figure 3.4a Number of pharmaceutical manufacturers*

* Cuba, Cyprus and Tunisia (1997), the rest (1998). Data for Australia include producers of prescription ad + OTC products (including complementary medicines and medical devices).

Figure 3.4b Number of pharmaceutical suppliers and retail pharmacies*

* Cyprus and the Netherlands (1997), the rest (1998).

The number of registered drugs, as shown in Figure 3.5, is higher in Australia and Malaysia than in Cuba, Estonia, Uganda and Zimbabwe. The larger the number of drugs on the market, the greater the burden of conducting systematic evaluation and re-evaluation of the safety and efficacy of drugs, carrying out post-marketing quality surveillance and monitoring ADR in drugs available on the market.

Figure 3.5 Number of registered pharmaceutical products for human use*

* Netherlands (1996), Tunisia (1997), others (1998)

** The number of products registered with the TGA is approximately 60 000 items (including prescription drugs, OTC medicines, complementary medicines and medical devices). Only approximate data for human pharmaceutical products are shown here.