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- Medicine Information and Evidence for Policy > Medicines Policy
(2003; 20 pages) [French] [Spanish]
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
• 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.