Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for Drug Regulatory Authorities - Regulatory Support Series No. 005
(1998; 213 pages)
Índice de contenido
Ver el documentoPREFACE
Ver el documentoI. INTRODUCTION
Abrir esta carpeta y ver su contenidoII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Cerrar esta carpetaIII. OPERATING ACTIVITIES
Ver el documentoA. Transparency
Ver el documentoB. Policies
Ver el documentoC. Administrative procedures
Ver el documentoD. Guidelines for applicants
Ver el documentoE. Model application form
Ver el documentoF. Communication among departments within the DRA
Ver el documentoG. Relationship of evaluators with GMP inspectors
Ver el documentoH. Relationship of evaluators with the quality control laboratories
Ver el documentoI. Functional relationship of the evaluators with the expert advisory body
Ver el documentoJ. Relationship of evaluators with the pharmaceutical industry and confidentiality of data
Ver el documentoK. Meetings with applicants
Ver el documentoL. Procedures for appeals
Ver el documentoM. Collaboration with other DRAs
Ver el documentoN. Collaboration with WHO
Ver el documentoO. Use of external experts as evaluators
Ver el documentoP. Timeframes for processing of applications
Ver el documentoQ. Publication of marketing authorization decisions
Abrir esta carpeta y ver su contenidoIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
Ver el documentoV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
Ver el documentoVI. VARIATIONS
Ver el documentoVII. PERIODIC REVIEWS
Ver el documentoVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
Ver el documentoGLOSSARY
Ver el documentoABBREVIATIONS
Ver el documentoREFERENCES
Abrir esta carpeta y ver su contenidoANNEXES
 

N. Collaboration with WHO

Regular publication of marketing authorization decisions is helpful to procurement and distribution networks and to other DRAs. This does not represent a breach of confidentiality as national registers are usually public documents. The WHO Pharmaceuticals Newsletter also publishes information on new marketing authorizations, as well as the latest regulatory safety information on, for example, withdrawals and changes in product information. DRAs are encouraged to transmit their regulatory decisions to the Department of Essential Drugs and other Medicines, WHO, 1211 Geneva 27, Switzerland.

WHO distributes an Alert to all DRAs when important drug safety problems are detected. The journal WHO Drug Information provides more in-depth information, together with a discussion of current topics in drug regulation. The United Nations and WHO jointly prepare a Consolidated List of Products Whose Consumption and/or Sale Have Been Banned, Withdrawn, Severely Restricted or not Approved by Governments. This publication enables DRAs which assess applications for marketing authorization to ascertain whether any restrictive action has been taken in other countries. It is updated periodically.

WHO also distributes information to DRAs about new ICH guidelines, both those under discussion and those that have been finalized.

Ir a la sección anterior Ir a la siguiente sección
 

Última actualización: le 24 abril 2012