WHO Expert Committee on Specifications for Pharmaceutical Preparations: Forty-ninthReport

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality, safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines, from their development to their distribution to patients. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP), distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below, including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project.