A major change in the approach to drug safety surveillance has been introduced in the last five years in the form of risk management planning and is extensively covered by guidelines in the volume 9A. In 2007, pharmacovigilance regulations were brought together in an update of 9A volume of the rules governing medical products in the European Union Guidelines on Pharmacovigilance for Medicinal Products for Human use. This volume is prepared by the European Commission in close consultation with the Member states, agencies and interested parties and is specifically related to human.

Volume 9A pharmacovigilance details the roles and responsibilities of NIAHs in ensuring that they have an appropriate system of pharmacovigilance in place in order to assure responsibility for their products on the market and to ensure that appropriate action can be taken when felt necessary. It also incorporates international agreements within the framework of the International Conference on Harmonization. It attempts to harmonize the disparate regulations and the practice of pharmacovigilance in the pharmaceutical industry and regulatory authorities.

Volume 9A pharmacovigilance was prepared to bring together general guidance on the requirements, procedures, roles and activities in this field for both Marketing Authorization Holders and Competent Authorities of medicinal products for human use. It is divided into four parts: Part I deals with guidelines for Marketing Authorization Holders, Part II deals with guidelines for Competent Authorities and the agency, Part III provides the guidelines for the electronic exchange of pharmacovigilance in the EU and part IV provides details on pharmacovigilance communication. According to the new guidance, authorities conduct routine inspections to determine that the Marketing Authorization Holder has personnel, systems and facilities in place to meet their regulatory obligations for centrally authorized products. These inspections are requested with one or more specific products selected for which specific information is traced and verified through the various processes in order to provide practical evidence of the functioning of the pharmacovigilance system of the Marketing authorization holder and their compliance with their regulatory obligations.

Thus, 9A document is a detailed guidance document concerning pharmacovigilance of human drugs in the European Union.