Over 240 participants from drug regulatory authorities in 113 countries were present at the 11th International Conference of Drug Regulatory Authorities (ICDRA), held in Madrid from 16 to 19 February 2004. In collaboration with WHO, the ICDRA was hosted by the Ministry of Health of Spain and the Spanish Agency for Medicines and Health Products (http://www.agemed.es), with the Minister of Health and the Director-General of WHO opening the proceedings.

Drug regulatory authorities are continually challenged by the rapid development and sophistication of medicinal products and new technologies. Such developments create a heavy demand on regulatory control systems, which are often unable to respond due to inadequate resources. The enlargement of distribution and access channels, growing use of the Internet, and penetration of substandard and counterfeit medicines into many markets compound the problem, and mean that the regulator's task is becoming increasingly daunting. One objective of the ICDRA is to give regulators the opportunity to exchange information, leverage collaboration and strengthen vital links with agencies experiencing similar problems.

The four-day programme covered many important topics affecting public health. WHO reported on progress in implementing recommendations from the 10th ICDRA. Among the subjects discussed were:

Regulatory assessment of combination products
Public health needs versus the market-place
Strengthening regulatory frameworks for medicinal products
Harmonization updates.

Recommendations from the 11th ICDRA will form a basis for future collaboration among WHO Member States, drug regulatory authorities, WHO, and interested agencies and institutions. They also set priorities for WHO actions and support. The recommendations are available in full in WHO Drug Information, Volume 18, Number 1, 2004. (http://www.who.int/druginformation).

Associated events

Three meetings associated with ICDRA were held prior to the Madrid Conference: the Second Regional Workshop on Regulation of Traditional Medicines (see below); the Pan American Network for Drug Regulatory Harmonization initiative (PANDRH); and the pre-ICDRA Workshop on Counterfeit Drugs. The latter was attended by 90 major players from diverse institutions and agencies, including regulators, representatives of the World Customs Organization, the World Intellectual Property Organization and Interpol, industry and NGOs. Discussions focused on their experiences in combating counterfeit drugs, and participants debated the feasibility of formulating an International Framework Treaty on Counterfeit Drugs.

The ICDRA remains an important forum for WHO and drug regulatory authorities to discuss problems and the latest developments in medicines regulation. It continues to review and analyse collaborative initiatives, with a focus on harmonization of medicines control, in order to improve the safety, efficacy and quality of medicines worldwide.