Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999: Annex 5. Fees collected for drug registration

Table of Contents

	Acknowledgements
	Acronyms and abbreviations
	Executive summary
	1. Drug regulation: an early concern
		1.1 Historical perspective
		1.2 National drug regulation
		1.3 Global initiatives
	2. Rationale for regulating drugs
	3. Where are we today?
	4. How can drug regulation be made effective?
		4.1 Assess drug regulation performance
		4.2 Identify and develop priority functions
		4.3 Provide a clear mission and purpose
		4.4 Create a supportive environment
		4.5 Formulate adequate drug legislation
		4.6 Create appropriate organizational structure
		4.7 Allocate adequate human and financial resources
		4.8 Minimize corruption and conflict of interest
		4.9 Apply most appropriate strategy
	5. The way forward
	Annex 1. Status of drug regulation and drug quality assurance in WHO African Region and selected countries
	Annex 2. A model framework for assessing drug regulation
	Annex 3. Possible approaches to developing drug regulation ^a
	Annex 4. Examples of mission statements concerning drug regulation
	Annex 5. Fees collected for drug registration
	References

Annex 5. Fees collected for drug registration

Table 1. Fees (in US$) collected for product registration in some developed countries

Type of service/fee	Australia	Canada	European Medicines Evaluation Agency	New Zealand	Norway
New chemical entities	500 to 56 000^a	92 000	170 000	8000	5300
Generic/non-prescription				40 000	5300
Variation			50 000	200^b 800^c
Renewal/5 years			12 000
Annual charge	300^d 500^e			None	0.5% of gross price
Control and use of fee by drug regulation authority	Yes	Yes	Yes	Yes	No

Table 2. Fees (in US$) collected for product registration in some developing countries

¹domestic products	⁴generic non-branded
²imported products	⁵generic, branded
³new chemical entities	⁶registration valid for three years