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Annual Report 2002 - Essential Drugs and Medicines Policy: Supporting Countries to Close the Access Gap
(2003; 20 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentDeveloping a monitoring culture to improve impact
View the documentTraditional and complementary medicine: putting policy into action
View the documentKey country support in Africa and Eastern Mediterranean
View the documentWHO Collaborating Centres: supplying active support for medicines work
View the documentHow is TRIPS affecting access to medicines?
View the documentDevelopment of the essential drugs concept over the past 25 years
View the documentMeasuring access to antimalarials
View the documentStrengthening regional and national bulk procurement
View the documentLearning from successful supply systems
View the documentWorking out the cost of medicines
View the documentSupporting MDG target on access to essential medicines
View the documentCommon guideline for evaluating new medicines in Baltic countries
View the documentNGO toolkit for improving access to HIV/AIDS treatment
View the documentHarmonizing medicines regulation in the Americas
View the documentGood manufacturing practice in China: rapid progress
View the documentPharmacovigilance: detecting and reporting adverse drug reactions
View the documentVariations in prescribing information in 26 countries
View the document10th ICDRA: an international basis for medicines regulation
View the documentFighting poor-quality drugs
View the documentImproving medicines use in hospitals in Cambodia and Lao PDR
View the documentWHO-India Essential Drugs Programme: multiplying impact
View the documentOman: improving antibiotic use in primary health care
 

Harmonizing medicines regulation in the Americas

In the Americas, harmonization is considered key to ensuring the production of good-quality pharmaceutical products by the region. WHO's Regional Office for the Americas/Pan American Health Organization (AMRO/PAHO) promotes and facilitates harmonization by integrating the various stakeholders in the harmonization process.

Every two years, a Conference on Drug Regulatory Harmonization is held as an open forum for discussing and endorsing proposals presented by technical expert groups. The 3rd Pan American Conference on Drug Regulatory Harmonization took place in April 2002. The Conference recommends actions that countries can undertake to promote harmonization. The 3rd Conference made many proposals, including:

Good Manufacturing Practice

• giving priority to training activities to improve GMP implementation
• adopting the WHO 1992 GMP guideline
• promoting implementation of a WHO-type Certificate of Quality of Pharmaceutical Products Subject to International Commerce


Bioequivalence

• using the same reference product for bioequivalence studies


Good clinical practice (GCP)

• harmonizing procedures for evaluating clinical trial protocols
• developing inspection guidelines for audits on GCP.


Based on studies on implementing and enforcing GMP in the region, the 2nd Conference (1999) recommended that GMP be the first priority in the harmonization process. AMRO/PAHO was especially active in GMP training - between April 2001 and September 2002, it organized 18 workshops on GMP in 18 countries. The workshops were attended by nearly 600 health professionals. Instructors were mostly professors of Latin American universities, with experience in GMP, pharmaceutical technology and quality systems. The courses are now being replicated by pharmacy schools of universities in Bolivia, Colombia, Honduras and Nicaragua.

 

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