Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Close this folderCurrent issues in regulation and quality
View the documentEnforcement of regulatory functions
View the documentQuality of starting materials and the role of pharmacopoeias
View the documentImplementation of good manufacturing practices
View the documentUpgrade of local production
View the documentRecommendations
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

WHO should:

1. Continue to serve as a platform for the exchange of information on important regulatory decisions of worldwide implication.

2. Take measures to reinforce the collaboration between drug regulatory and criminal investigation authorities internationally, in particular Interpol and the World Customs Organization, to deal with criminal activities involving pharmaceutical products and materials.

3. Implement recommendations on safe trade and control of starting materials as set out in document WHO/PHARM/98.605, including risk assessment of starting materials.

4. Develop safe trading practices in close collaboration with brokers, traders and other international organizations and institutions.

5. Support training of assessors for new drug applications and good manufacturing practice (GMP) inspectors in countries with limited resources, in collaboration with national health authorities.


Countries should:

6. Establish a structure to facilitate close collaboration between the regulatory authority granting marketing authorizations for pharmaceuticals and inspection bodies.

7. Develop a plan for implementation of drug regulation, and monitor progress.

8. Implement quality systems for pharmaceuticals that are also appropriate to starting materials intended for export.

 

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Last updated: April 24, 2012