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)
Table des matières
Afficher le documentPREFACE
Afficher le documentI. INTRODUCTION
Ouvrir ce répertoire et afficher son contenuII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Fermer ce répertoireIII. OPERATING ACTIVITIES
Afficher le documentA. Transparency
Afficher le documentB. Policies
Afficher le documentC. Administrative procedures
Afficher le documentD. Guidelines for applicants
Afficher le documentE. Model application form
Afficher le documentF. Communication among departments within the DRA
Afficher le documentG. Relationship of evaluators with GMP inspectors
Afficher le documentH. Relationship of evaluators with the quality control laboratories
Afficher le documentI. Functional relationship of the evaluators with the expert advisory body
Afficher le documentJ. Relationship of evaluators with the pharmaceutical industry and confidentiality of data
Afficher le documentK. Meetings with applicants
Afficher le documentL. Procedures for appeals
Afficher le documentM. Collaboration with other DRAs
Afficher le documentN. Collaboration with WHO
Afficher le documentO. Use of external experts as evaluators
Afficher le documentP. Timeframes for processing of applications
Afficher le documentQ. Publication of marketing authorization decisions
Ouvrir ce répertoire et afficher son contenuIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
Afficher le documentV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
Afficher le documentVI. VARIATIONS
Afficher le documentVII. PERIODIC REVIEWS
Afficher le documentVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
Afficher le documentGLOSSARY
Afficher le documentABBREVIATIONS
Afficher le documentREFERENCES
Ouvrir ce répertoire et afficher son contenuANNEXES
 

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.

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Dernière mise à jour: le 24 avril 2012