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 of Contents
View the documentPREFACE
View the documentI. INTRODUCTION
Open this folder and view contentsII. PROVISIONS AND PREREQUISITES FOR REGULATORY CONTROL
Close this folderIII. OPERATING ACTIVITIES
View the documentA. Transparency
View the documentB. Policies
View the documentC. Administrative procedures
View the documentD. Guidelines for applicants
View the documentE. Model application form
View the documentF. Communication among departments within the DRA
View the documentG. Relationship of evaluators with GMP inspectors
View the documentH. Relationship of evaluators with the quality control laboratories
View the documentI. Functional relationship of the evaluators with the expert advisory body
View the documentJ. Relationship of evaluators with the pharmaceutical industry and confidentiality of data
View the documentK. Meetings with applicants
View the documentL. Procedures for appeals
View the documentM. Collaboration with other DRAs
View the documentN. Collaboration with WHO
View the documentO. Use of external experts as evaluators
View the documentP. Timeframes for processing of applications
View the documentQ. Publication of marketing authorization decisions
Open this folder and view contentsIV. REVIEW OF APPLICATIONS FOR MARKETING AUTHORIZATION OF MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS
View the documentV. ISSUE OF WRITTEN MARKETING AUTHORIZATION
View the documentVI. VARIATIONS
View the documentVII. PERIODIC REVIEWS
View the documentVIII. SUSPENSION AND REVOCATION OF MARKETING AUTHORIZATION
View the documentGLOSSARY
View the documentABBREVIATIONS
View the documentREFERENCES
Open this folder and view contentsANNEXES
 

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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Last updated: January 19, 2012