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[e-drug] Second Edition of the WHO's Blue Book is now available


  • From: "Azatyan, Samvel" <azatyans@who.int>
  • Date: Thu, 8 Sep 2011 12:23:10 +0200

E-DRUG: Second Edition of the WHO's Blue Book is now available
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In 1999, WHO published a manual entitled Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) products - a Manual for a Drug Regulatory Authority. After an initial distribution of two thousand copies to the Regulatory Authorities of WHO member countries, more than three thousand additional copies were printed and distributed in response to requests. Feedback was received from many who have used the manual in their assessment work or in training courses.

The manual became known as the Blue Book and is intended to provide guidance to countries that do not already have a fully developed system of premarket evaluation and market authorization, and have a particular interest in the assessment and authorization of multisource (generic) pharmaceutical products. Many of the principles apply to other groups of medicines (such as complex biologicals and 'alternative' preparations), but most details may be specific to multisource products. This is the second edition of the Blue Book. In developing this new edition, many practical suggestions made by regulatory officials were taken into account and incorporated as far as possible.

The new Blue Book is now available electronically at the WHO website: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/blue_book/en/index.html

Samvel Azatyan M.D., Ph.D. | Manager, Medicines Regulatory Support Programme [MRS]
Quality Assurance and Safety: Medicines
Department of Essential Medicines and Pharmaceutical Policies (EMP)
World Health Organization
20, Avenue Appia, CH-1211, Geneva 27, Switzerland
Direct phone: +41 22 791 1506 | Fax: +4122 791 4167
E-mail: azatyans@who.int