Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999: Annex 3. Possible approaches to developing drug regulation a

Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999
(1999; 53 pages) [French]

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 3. Possible approaches to developing drug regulation ^a

Level I^b	Level II^c	Level III^d	Level IV^e
Formulate drug legislation and regulations	Revise and update drug legislation and regulations as required	Revise and update drug legislation and regulations as required	Revise and update existing comprehensive drug legislation and regulations as required
Establish regulatory authority	Strengthen regulatory authority	Strengthen regulatory authority	Maintain strong regulatory authority
Create mandatory licensing system for private and public sector drug importers, wholesalers, retail outlets and drug dispensaries of healthcare facilities	Develop capacity to license drug manufacturers	Develop capacity to license persons, premises and practices in pharmaceutical trade	Maintain developed capacity
Create a simple product inventory or licensing system based on the submission of: • A WHO-type certificate of pharmaceutical product, and • evidence of registration in another three or five selected reference countries (countries with reliable drug regulation, including GMP inspection and product assessment)	Strengthen capacity to undertake: • full assessment of applications for marketing authorization of generic products based on chemistry and pharmaceutical data • registration of new products on the basis of: • provision of information on the basis of that provided by exporting countries (summary of product characteristics/data sheet and WHO-type certificate of a pharmaceutical product); • provision of evidence of registration in another three or five countries reference countries (countries with reliable drug regulation, including GMP inspection and product assessment)	Develop capacity to make full assessment of new drug applications including biological products	Maintain developed capacity to make full assessment of new drug applications, including biotechnology products
Control imports by: • defining the points of entry for pharmaceutical products; • issuing a permit for each consignment to be imported; • requesting a batch certificate for imported products	Control imports by: • maintaining the points of entry/custom ports for pharmaceutical products; • requesting a batch certificate for imported products	Control imports by: • maintaining the points of entry/custom ports for pharmaceutical products; • requesting a batch certificate for imported products	Control imports by: • maintaining the points of entry/custom ports for pharmaceutical products; • requesting a batch certificate for imported biological and biotechnology products
Establish inspectorate for drug distribution channels	Develop capacity to perform GMP inspections	Develop capacity to perform GMP inspection	Maintain developed capacity to undertake all types of inspections
Test quality of drugs when needed, using in-country or external laboratory	Establish a drug quality control laboratory to perform basic physico-chemical tests and assays	Develop capacity to make complete compendial physico-chemical tests and assays, and some tests and assays on biological products	Develop quality control laboratory to perform all types of tests and assays on marketed products including biological and biotechnology products and conduct research in the area of quality
Initiate a data system for storing information about licensed establishments and drugs	Strengthen capacity to store information on other activities	Strengthen capacity to include more activities	Maintain developed data retrieval system for all activities
	Start post-marketing quality monitoring activity on target products	Develop capacity to conduct post-marketing quality monitoring on a wider number of marketed drugs	Maintain developed capacity to conduct post-marketing quality monitoring of all marketed drugs
	Initiate drug information system for the public	Develop capacity to provide drug information to the public and professionals	Ensure drug information centre is able to undertake research work
		Establish system for post-marketing surveillance of safety of drugs	Maintain developed capacity to conduct post-marketing surveillance for safety of drugs
		Initiate clinical control trial of drugs	Maintain developed capacity to control clinical trial
		Initiate control of drug promotion and advertising	Maintain developed capacity to control drug promotion and advertising
		Issue WHO type-certificate of a pharmaceutical product for exported products	Maintain developed capacity to issue WHO-type certificates for exported products including biological and bio-tech products
			Maintain developed capacity to conduct post-marketing surveillance for efficacy of drugs
			Develop national quality standards or collaborate with others in the development of such standards

^a Ideally, drug regulation should match the level of development of the country’s pharmaceutical sector, but in reality a country’s pharmaceutical sector may be more highly evolved than it’s regulatory capacity.

^b Countries depending on imported drugs (no domestic production) and having limited human and other resources for establishing drug regulation.

^c Countries with some domestic production of generic drugs and limited capacity to develop drug regulation.

^d Countries with domestic production, generic and other drugs and who export to other countries (intermediate level of development).

^e Countries with a developed pharmaceutical industry.

^f Countries depending on imported drugs (no domestic production) and having limited human and other resources for establishing drug regulation.

^g Countries with some domestic production of generic drugs and limited capacity to develop drug regulation.

^h Countries with domestic production of generic and other drugs and who export to other countries (intermediate level of development).

ⁱ Countries with a developed pharmaceutical industry.