E-DRUG: International meeting of world pharmacopoeias
Setting international standards for medicines
21 MARCH 2012 | GENEVA: In a world of increased globalization of medicine
production and distribution, international pharmaceutical standards are
becomingly increasingly important to safeguard quality and improve access to
At a meeting hosted by the World Health Organization (WHO) in Geneva earlier
this month, countries showed unprecedented commitment to working together to
strengthen international standards. For the first time in 10 years,
representatives from 23 pharmacopoeias and pharmacopeia commissions came
together and committed to working further towards harmonization and
strengthening WHO's role when developing global standards for the production
and testing of medicines.
"This is a significant milestone in the goal towards global access to quality
medicines," says Dr Sabine Kopp, from the Department of Essential Medicines and
Health Products at WHO. "Countries are showing genuine willingness to share
information and harmonize development of their own pharmacopoeial standards
within the international context."
A pharmacopoeia (from the Greek meaning "drug-making") is a reference
containing compliance specifications for pharmaceutical medicines. Usually
published by government authorities in each country, a pharmacopoeia provides
the standards for an independent check of the quality of a medicine at any time
during its shelf-life.
First attempts at standardizing the composition of drugs worldwide dates back
to 1874. Following work in the early 1900s by the Belgian Government and the
League of Nations, WHO took on the job of developing an international
pharmacopoeia in 1947. "Our ancestors had a vision that all medicines would be
tested using the same set of specifications for checking their quality. We
should not lose this dream," says Dr Kopp.
Since the publication of the first volume in 1951, the International
Pharmacopoeia published by WHO has evolved to focus on the needs of developing
countries, with priority given to medicines listed on the WHO Model List of
Essential Medicines as well as new medicines for diseases including HIV and
Harmonization of standards has become increasingly important for public health
for several reasons, one of the most important being to combat falsified and
substandard medicines. "The latest incident in Pakistan where 125 died due to
contamination of heart medicines with an antimalarial drug is very sad proof of
the need for action," says Dr
Kopp. Testing of suspected medicines was a key element of the investigation and
this process exposed limitations to using pharmacopoeial tests. Tests done to
International Pharmacopoeia standards are intended to be applicable
internationally and pick up more contaminants than tests done to one single
Uniform global standards will also help to expand access to medicines in
developing countries. When each country has its own specifications for
medicines, this makes it very expensive for manufacturers to tailor their
exports to each country's requirements. If standards are not harmonized, the
costs of checking quality also increase.
The meeting held 29 February - 2 March 2012 has released momentum for greater
collaborative work and sharing of information between world pharmacopoeias.
Future projects discussed include a new
internet-based system for information exchange, hosted by WHO, as well as a
guide to "good pharmacopoeial practices", currently under development by a
group of representatives from Argentina, Brazil, the European Pharmacopoeia,
India, Japan, Mexico, the Russian Federation, Ukraine, the United Kingdom of
Great Britain and Northern Ireland and the United States Pharmacopeia.
Opportunities for further collaboration this year include the International
Pharmaceutical Federation (FIP) Centennial congress in Amsterdam on 3-8 October
2012 and the International Conference of Drug Regulatory Authorities (ICDRA)
conference in Tallinn, Estonia also in October.
Further information can be found on the following web sites:
The International Pharmacopoeia:
For more information, please contact:
Dr Sabine Kopp
Quality Assurance and Safety: Medicines
Department of Essential Medicines and Health Products
World Health Organization