Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products: A Manual for National Medicines Regulatory Authorities (NMRAs) – 2nd Edition
(2011; 148 pages)


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.

Now included are a series of documents that will be of practical assistance to regulatory authorities, including checklists, flow charts, model evaluation reports and model correspondence. Relevant WHO guidelines (such as those concerning stability and bio-equivalence testing) are referenced in the text but are no longer attached for these reasons:

With the additional material to be incorporated in this edition, the Blue Book could have become long and cumbersome;

Updated versions of guidelines may become available before a new version of the Blue Book is produced;

All of the relevant guidelines are available via the WHO website.

An important addition is the section concerning Good Regulatory Practice. The Blue Book should be seen as a dynamic document that responds to a rapidly changing environment. Further updates may be anticipated. When the book will be published it may not reflect the latest WHO guidelines nor the latest Prequalification practices and readers should note that when documentation or websites are referenced, the latest edition should be consulted.

This manual aims at providing technical advice to countries intending to strengthen their pre-marketing evaluation and marketing authorization system.

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