The National Drug Regulatory Authorities (DRAs) of Central America (seven countries) and the An- dean Group (six countries) of the American Region, met in February and August 2001 respectively, and issues discussed included vaccine registration and drug donation in emergency situations. Even though drug registration is a requirement for importing drugs, it is often waived for vaccine imports. This requirement was discussed and provisions made to facilitate vaccine registration through review of national legislation, as part of the drug regulatory harmonization process. The group also identified the need for training for site inspection as part of the quality assurance programme of the DRAs.

Both groups of DRAs also analysed their role in drug donations in emergency situations. In each of the countries, the Minister of Health has led the coordination effort of international and national aid agencies. Many NGOs have participated actively in the process, but DRAs have hardly been involved at all. Following assessment of drug donation management during recent emergencies in Bolivia, El Salvador and Peru, the DRAs decided to discuss their role and responsibilities in managing drug donations. Problems observed during many previous emergencies persist: short expiration dates; inadequate labelling; unidentified drugs; and drugs not included on the national essential drugs list. The groups concluded that DRAs must participate more actively if drug donations are to be manageda more effectively. The potential roles of schools of pharmacy and national associations of pharmacists also need to be evaluated.