Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Ver el documento en el formato PDF
Índice de contenido
Abrir esta carpeta y ver su contenidoOpening Ceremony
Abrir esta carpeta y ver su contenidoGood regulatory practice
Abrir esta carpeta y ver su contenidoGood certification practice
Abrir esta carpeta y ver su contenidoCounterfeit drugs: challenges and solutions
Cerrar esta carpetaCurrent issues in regulation and quality
Ver el documentoEnforcement of regulatory functions
Ver el documentoQuality of starting materials and the role of pharmacopoeias
Ver el documentoImplementation of good manufacturing practices
Ver el documentoUpgrade of local production
Ver el documentoRecommendations
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization: implementation and implications
Abrir esta carpeta y ver su contenidoDrug utilization studies
Abrir esta carpeta y ver su contenidoInternational Conference on Harmonization and the common technical document
Abrir esta carpeta y ver su contenidoKeynote address
Abrir esta carpeta y ver su contenidoGlobal and national efforts to reduce tobacco use
Abrir esta carpeta y ver su contenidoElectronic communication in the regulatory process
Abrir esta carpeta y ver su contenidoTransparency in monitoring the safety of medicines
Abrir esta carpeta y ver su contenidoPharmaceutical products for use in special groups
Abrir esta carpeta y ver su contenidoNeed for Bioequivalence
Abrir esta carpeta y ver su contenidoAntimicrobial resistance: battling the bugs
Abrir esta carpeta y ver su contenidoSafety issues of plasma-derived medicinal products
Abrir esta carpeta y ver su contenidoHerbal medicines
Abrir esta carpeta y ver su contenidoRegulation and access to essential drugs
Ver el documentoParticipants
Ver el documentoBack 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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Última actualización: le 3 mayo 2013