How to Develop and Implement a National Drug Policy (Second Edition): Part II: Key components of a national drug policy: 8. Drug regulation: 8.9 Information exchange with WHO and with other agencies

How to Develop and Implement a National Drug Policy (Second Edition)
(2001; 96 pages) [French] [Spanish]

Table of Contents

Contributors
Abbreviations and acronyms
Preface
Part I: How to develop and implement a national drug policy
	1. Introduction
		1.1 Essential drugs are not used to their full potential
		1.2 What is a national drug policy?
		1.3 Key components of a national drug policy
	2. The national drug policy process
		2.1 Overview of the national drug policy process
		2.2 Formulating a national drug policy
		2.3 Implementing a national drug policy
		2.4 Monitoring and evaluation
	3. Legislation
		3.1 Importance of legislation and regulations
		3.2 Framework for drug legislation
		3.3 Developing drug legislation and regulations
Part II: Key components of a national drug policy
	4. Selection of essential drugs
		4.1 Essential drugs
		4.2 Old problems and new challenges
		4.3 Strategies for the selection of essential drugs
		4.4 Traditional and herbal medicines
	5. Affordability
		5.1 Challenges
		5.2 Strategies to increase affordability
	6. Drug financing
		6.1 Challenges
		6.2 Drug financing options
	7. Supply systems
		7.1 Public or private? Or mixed?
		7.2 Drug procurement
		7.3 Local manufacture
		7.4 Distribution strategies
		7.5 Drug supply in emergency situations
	8. Drug regulation
		8.1 Need for drug regulation and quality assurance
		8.2 Basic requirements for drug regulation
		8.3 Core elements of drug regulation
		8.4 Stepwise approach to drug registration
		8.5 Quality
		8.6 Safety
		8.7 Efficacy
		8.8 Information and drug promotion
		8.9 Information exchange with WHO and with other agencies
	9. Rational use of drugs
		9.1 Why is it important to promote rational use?
		9.2 Challenges
		9.3 Planning for activities to promote rational use of drugs
		9.4 Core strategies to improve drug use
		9.5 Educational strategies
		9.6 Managerial strategies to promote rational drug use
		9.7 Regulatory strategies to promote rational drug use
		9.8 Promoting rational drug use in the private sector
	10. Research
		10.1 Introduction
		10.2 Strategies to promote research
	11. Human resources development
		11.1 Introduction
		11.2 Strategies for human resource development
	12. Monitoring and evaluation
		12.1 Monitoring and evaluation are part of a national drug policy
References
Selected WHO publications and documents of related interest
Back cover

8.9 Information exchange with WHO and with other agencies

There are many ways in which drug regulatory authorities can exchange information between themselves or with international bodies such as WHO. These are some of the mechanisms:

• Drug Safety Alerts: information issued by WHO in case of serious warnings on quality or safety. Also on http://www.who.int/medicines/organization/qsm/activities/drugsafety/orgqsmalerts.shtml

• WHO Pharmaceutical Newsletter: a monthly newsletter issued by WHO with information on regulatory decisions by other regulatory agencies. Also on http://www.who.int/medicines/organization/qsm/activities/drugsafety/orgpharmanews.shtml

• WHO Drug Information: a quarterly publication with more general drug-related information, as well as reprints of important documents, such as the WHO Model List of Essential Drugs. Also on http://www.who.int/druginformation/

• UN Consolidated List of Products whose Consumption and/or Sale have been banned, withdrawn, severely restricted or not approved by Governments. Issued by the United Nations: this will be made available through the WHO web site: http://www.who.int/medicines

• WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce (see section 8.5): also on http://www.who.int/medicines/organization/qsm/activities/drugregul/certification/certifscheme.shtml

• WHODRA web site (with registered access): http://mednet.who.int/

• United Nations Office for Drug Control and Crime Prevention (e.g. list of controlled drugs, international conventions): http://www.undcp.org

• Electronic discussion groups, such as E-drug: to subscribe contact: majordomo@usa.healthnet.org In text of message put subscribe e-drug (French and Spanish language versions also available). Also INDICES contact: majordomo@usa.healthnet.org In text of message put: Subscribe indices)

Examples of national web sites are:

Australia: http://www.health.gov.au/tga
Brazil: http://www.saude.gov.br/
Canada: http://www.hc-sc.gc.ca/hpb-dgps/therapeut/
Estonia: http://www.sam.ee/
France: http://agmed.sante.gouv.fr/
Mexico: http://www.ssa.gob.mx/
Netherlands: http://www.cbg-meb.nl/
Peru: http://www.digesa.sld.pe/
South Africa: http://www.health.gov.za/crrp.htm
Spain: http://www.cof.es/bot/
Sweden: http://www.mpa.se/ie_engindex.html
Thailand: http://www.fda.moph.go.th/fdaindex.htm
USA: http://www.fda.gov/default.htm
Also: European Medicines Evaluation Agency: http://www.eudra.org/en_home.htm