New rules on pharmacovigilance in Europe: more of the same?

Abstract

The European Commission has published the new Volume 9 – Pharmacovigilance, Medicinal Products for Human and Veterinary Use – of the Rules Governing Medicinal Products in the European Union. This guidance, drawn up as required by European law, is available on the Commission’s website [1]. Three years in gestation, it ‘is intended to update and replace pharmacovigilance guidance published in the Community prior to 30th September 2001’. Amusingly, at the time of writing (at the end of January 2002), the ‘What’s new’ section of the website of the European Agency for the Evaluation of Medicinal Products (EMEA) mentions the establishment of its new Communications and Networking unit, but the site still shows the (now obsolete) 1999 pharmacovigilance guidelines [2]. Volume 9 ‘is specifically related to pharmacovigilance. It brings together for the first time, general guidance on the requirements, procedures, roles and activities in this field, for both industry and regulators . . . and incorporates international agreements . . . of the International Conference on Harmonization (ICH)’. The document comprises four parts: Medicinal products for human use; Veterinary medicinal products; EU electronic exchange of pharmacovigilance information; and Reference legislative and administrative information. Concentrating our attention on part 1, there are sections comprising: the Notice to Marketing Authorization (MA) Holders; Guidance and procedures for Competent Authorities; and Terminology. The Notice to MA Holders deals with adverse reaction reporting (except for clinical trials on unauthorized medicines); periodic safety update reports; company-sponsored post-authorization safety studies; and ongoing pharmacovigilance after authorization. The guidance for competent authorities includes the principles of pharmacovigilance, as well as processes, roles and responsibilities of regulators for products authorized under the different national and European procedures and the procedure for reporting to the World Health Organization (WHO). There is a crisis management plan, the communications procedure (rapid alert system and non-urgent system) and the standard operating procedure for referral to the Committee on Proprietary Medicinal Products (CPMP) of safety concerns in the European Union. However, we advise not to spend too much time reading all of this guidance, half of which is ‘expected to be revised early in 2002’. So what is the impact of Volume 9 on the performance of drug safety surveillance and regulatory safety reporting in Europe and how does it differ from the preceding CPMP guidance [3]? Circumventing the more incomprehensible of the Euro-mandarin statements (such as ‘Community acquis’ and the ‘Approximation of the laws, regulations and administrative provision of the Member States’), Volume 9 introduces many changes in the technical details of the regulatory requirements for pharmacovigilance. Some of these may require alterations to working practices in company drug safety departments. As an example, the inclusion of Norway, Iceland and Liechtenstein in the European regulatory framework requires changes to processes for adverse reaction reporting. There is a new requirement for certain adverse reactions to non-centrally authorized products to be expedited ‘in such a way as to be available to the Agency’, with reports to the Agency (i.e. the EMEA) made electronically. This latter requirement is not feasible at present for most companies. However, it is the new interest of the EMEA in the safety of non-centrally authorized products that is particularly interesting. Volume 9 also makes absolutely clear the commitment of the European regulators to the early implementation of electronic adverse event reporting. There is an important addition to the role of the qualified person responsible for pharmacovigilance (QP). If information that may affect the benefit–risk evaluation of a product becomes available in the period between submission and grant of a marketing authorization, it is now the legal duty of the QP immediately to submit that information to the respective regulatory authorities. Hence, the QP has responsibilities that are not limited – as before – to marketed or authorized products: for many companies, this will require major changes to processes, to ensure involvement of the QP in pre-registration activities. The omission of a sub-heading ‘Content of suspected serious adverse drug reaction reports’ (which was present in the previous guidance) now makes it seem that the regulatory requirements for the minimum information for case validity, the INTERNATIONAL JOURNAL OF PHARMACEUTICAL MEDICINE 2002, 16:3 – 4 & 3