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
 

Value of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience

Mr Mohammed Zin Che Awang, Malaysia

The PIC/S was implemented in 1995. Its objectives are to facilitate networking and confidence-building, to promote the quality of inspections and quality assurance of inspectorates, to coordinate training of inspectors, to provide a framework for the exchange of information and experience in GMP, and to enhance global harmonization of GMP.

Malaysia applied to join the PIC/S in February 2000. After assessment of the Malaysian documents on the regulatory system, an assessment visit by a PIC/S team was made in March 2001 and a reassessment visit in November 2001. Malaysia was accepted as the 26th member in January 2002.

There is a need to harmonize GMP inspection standards through the training of inspectors in developing countries to ascertain the quality of starting materials and manufactured pharmaceutical products and the PIC/s provides a platform for activities in this area.

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