Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuOpening Ceremony
Ouvrir ce répertoire et afficher son contenuGood regulatory practice
Ouvrir ce répertoire et afficher son contenuGood certification practice
Ouvrir ce répertoire et afficher son contenuCounterfeit drugs: challenges and solutions
Fermer ce répertoireCurrent issues in regulation and quality
Afficher le documentEnforcement of regulatory functions
Afficher le documentQuality of starting materials and the role of pharmacopoeias
Afficher le documentImplementation of good manufacturing practices
Afficher le documentUpgrade of local production
Afficher le documentRecommendations
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization: implementation and implications
Ouvrir ce répertoire et afficher son contenuDrug utilization studies
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization and the common technical document
Ouvrir ce répertoire et afficher son contenuKeynote address
Ouvrir ce répertoire et afficher son contenuGlobal and national efforts to reduce tobacco use
Ouvrir ce répertoire et afficher son contenuElectronic communication in the regulatory process
Ouvrir ce répertoire et afficher son contenuTransparency in monitoring the safety of medicines
Ouvrir ce répertoire et afficher son contenuPharmaceutical products for use in special groups
Ouvrir ce répertoire et afficher son contenuNeed for Bioequivalence
Ouvrir ce répertoire et afficher son contenuAntimicrobial resistance: battling the bugs
Ouvrir ce répertoire et afficher son contenuSafety issues of plasma-derived medicinal products
Ouvrir ce répertoire et afficher son contenuHerbal medicines
Ouvrir ce répertoire et afficher son contenuRegulation and access to essential drugs
Afficher le documentParticipants
Afficher le 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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Dernière mise à jour: le 3 mai 2013