The unit responsible for assessment and registration generally comes within the same organizational structure as other drug regulatory units. The financing of the registration function in each of the countries is therefore the same as the financing of other regulatory functions, as discussed in Chapter 5.
Each of the countries collects fees for carrying out registration. Different rates generally apply for registration of products in different categories. Registration fees for new chemical entities are higher than those for generic and fast-track products. Some countries-Uganda and Zimbabwe, for example-have different rates for domestic and foreign products. For instance, Zimbabwe charges US$1 000 for an imported product and only about US$40 for a domestic product (see Table 5.5).
Registration fees vary significantly between countries (see Figure 8.2). Registering a new drug can cost the applicant as much as US$120 000 in Australia or as little as US$100 in Malaysia. The fees charged by the Australian TGA are eight times higher than those charged by the MEB in the Netherlands, even though both countries request similar documentation and both perform an independent assessment.
Figure 8.2 Fees charged for registration of products containing new chemical entities
As indicated in Chapter 5, the Zimbabwean and Australian drug regulatory authorities rely entirely on the fees they charge for their services to cover all their operating costs. The level of registration varies enormously between the two countries and probably reflects significant differences in regulation costs. The MCAZ has only 51 staff, whereas the Australian TGA has 500 (Table 5.3). And only nine people are responsible for multiple regulatory functions, including registration, at the Medicines Control Agency, while 188 people (full-time equivalent) carry out registration for the TGA. Salary level is another key determinant of fee level. Information on the average salary of registration staff was not available for this study, but the salary of inspectors provides some insight. A GMP inspector at the TGA earns 10 times more than his/her Zimbabwean counterpart.
Despite their high level, the fees charged by the TGA are based on an agreement between the Administration and the pharmaceutical industry. Although the Australian pharmaceutical industry pays high costs in terms of registration fees, it does not benefit in terms of registration time. Registration of a drug that contains a new chemical entity in Australia takes 12-16 months on an average (Figure 8.4).