Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Close this folderCurrent topics
View the document“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
View the documentWHO Certification Scheme: input for implementation
View the documentValue of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
View the documentPharmacopoeial specifications for new drug entities
View the documentImproving the impact of drug regulatory authorities on public health
View the documentStrengthening drug regulatory authorities in small Pacific Island nations
View the documentTransparency of data
View the documentKava
View the documentXenotransplantation and xenotourism: time for concerted regulatory action
View the documentRecommendations
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Pharmacopoeial specifications for new drug entities

Dr Ashwini Kumar, India

The availability of harmonized quality specifications of drugs through pharmacopoeias is central to all drug regulatory authorities for the access to safe, efficacious and quality medicines. There are some new drugs that are internationally traded and included in the WHO Essential Drugs Lists, but for which there are no readily available pharmacopoeial specifications.

A meeting was arranged during the 10th ICDRA, with participants from Brazil, China, Czech Republic, India, Russian Federation, Thailand and Zimbabwe, and telephone links to the European Pharmacopoeia and the United States Pharmacopeia, to discuss the development of pharmaceutical specifications for new drug entities. Efforts are needed to encourage international harmonization in the development of common specifications and international reference standards, with a special focus on new drug entities and drugs with major health impact, and the development of screening tests to help combat counterfeit drugs. It was agreed that the topic of pharmacopoeial requirements should be proposed for inclusion in the next ICDRA.

Role of drug regulatory authorities

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