Essential medicines and health products

International Meetings of World Pharmacopoeias

people meeting image

A pharmacopoeia is a legally-binding collection, prepared by a national or regional authority, of standards and quality specifications for medicines used in that country or region.

Some 60 pharmacopoeias (national, regional and subregional and international) are listed in the index below.

WHO initiated steps based on discussion during meetings of the International Conference of Drug Regulatory Authorities (ICDRA), especially the 10th ICDRA meeting held in Hong Kong in 2002, and a further discussion among regulators during the 11th ICDRA meeting held in Madrid in 2004, to organize an official meeting entitled International meeting of world pharmacopoeias for participation of all WHO Member States' pharmacopoeias worldwide, be they national, regional or international.

International Meetings of World Pharmacopoeias

On 10th anniversary of the Meeting of World Pharmacopoeias, increased global cooperation promises improved quality of medical products

20.3.2019 – The 10th anniversary meeting of the World Pharmacopoeias was hosted by WHO this month. Over 50 national and regional pharmacopoeial authorities committed to strengthen their cooperation. This should ensure that quality standards for medical products are available and respected across borders, thereby improving public health outcomes for patients.

Pharmacopoeias set the standards for the quality of medical products so that manufacturers can produce medicines and vaccines that work appropriately without harming patients. To ensure that manufacturers comply with those standards, medical products regulators then assess the products against the standards set before they allow them onto markets and in health facilities.

A concrete step towards strengthened cooperation has been the development of a rapid alert system to exchange information and take urgent action during health emergencies. The European Pharmacopoeia shared background information on a recent incident related to the contamination of a specific family of anti-hypertensive medicines (sartans) which had affected worldwide supplies of these medicines and outlined measures it had taken to introduce rigorous control of such impurities, thereby limiting further damage to patients. The contaminants were substances (nitrosamines) known as potentially carcinogenic for humans.

Ways and modalities for collaboration are currently being established and a white paper will explain the role and added value of pharmacopoeias in the health system.

The meeting also saw the publication of a new web site hosted by WHO that provides an index of world pharmacopoeias and relevant authorities, links to good pharmacopoeial practices and to reference standards:
International Meetings of World Pharmacopoeias

“The fact that the largest pharmacopoeias were present - including from Brazil, China, Europe, India, Indonesia, Japan, Russia and USA - is testimony to the fact that global cooperation is very much on everyone’s agenda,” said Dr Mariângela Simão, WHO Assistant Director General for access to medical products. “This is good news because access to safe and effective medicines in a globalized economy can only occur when manufacture, storage and distribution follow unified and rigorous quality standards.”

WHO will continue providing secretarial assistance to this unique platform for national and regional pharmacopoeias to share knowledge and cooperate for the benefit of public health.

Outcomes of the meeting

Good Pharmacopoeial Practice