Essential medicines and health products

Regulatory information and practical manuals

WHO Medicines Regulatory Package

WHO medicines regulatory package CD

Different models for medicines regulation exist across the world, and in many countries medicines regulatory procedures are still largely ineffective, due to chronic shortages of human and technical resources. Regulatory agencies in developing countries are resource constrained in terms of staffing, standards, systems, and training. As part of the normative role that WHO plays, most of the standards, norms and guidelines have been developed, and the extent of implementation varies from one region to the other. There are a number of factors that explain observed weaknesses of medicines regulation, and these differ from country to country and depend also on the health system. Countries may vary regarding their registration system and not all of them can implement a comprehensive medicine evaluation and registration system.

Marketing authorization of pharmaceutical products with special reference to multisource (generic) products: a manual for National Medicines Regulatory Authorities (NMRAs) – 2nd edition

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.