Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 45

The regulations, laws, guidances, guidelines, and other relevant documents covering drug safety are detailed, arcane, and scattered throughout multiple places in the Code of Federal Regulations (CFR) for the US and in various venues for European Union (EU) and member state documents. The EU PV requirements are designed at the EMA level (Regulations, Directives, and Guidances) and then implemented in each EU country; nevertheless, some countries can be more (but never less) demanding. Most of the EU documents are updated fairly frequently. Most other countries in the world have their own set of local laws, regulations, and guidances (often available only in the local language).

Requirements in most countries are fairly similar in their intent of protecting patient safety (including subjects in clinical trials). Most local regulations require nearly all SAEs and some non-serious AEs to be reported quickly if there appears to be a potential impact on public health. The definitions of “serious” and “non-serious” AEs are more or less standardized, although there are nuances that apply in various jurisdictions.

More “routine” individual AEs are analyzed and reported at periodic intervals. Most countries also require some form of aggregate reporting of serious and non-serious AEs at periodic intervals (e.g., every 3 months, 6 months, yearly, every 3 years), depending upon whether the drug is in clinical trials or on the market and whether it is new or old. Although the rules are similar throughout the world, they are sufficiently different in detail (“the devil is in the details”) to be infuriating and well nigh impossible to track, categorize, and keep up to date without personnel in each country tracking such matters. The major documents for the US and the EU are listed below. Those with an asterisk should be read and digested by anyone doing drug safety for a living. The contents of these documents are topics of this book. In the US, FDA’s regulation-making authority derives from legislation passed by the US Congress and signed into law by the US President. Most of the FDA-directed legislation gives FDA broad ability to introduce regulations and to enforce the related requirements. The FDA regulations do not explicitly state that a department or group must exist to deal with drug safety. Rather, sponsor/applicant obligations are spelled out. A “sponsor” is responsible for clinical trials and an “applicant” is responsible for meeting requirements associated with a marketing application and in the post-marketing phase. To do this adequately, an organized system or department is necessary.

The EU regulations are more specific and require that a formal pharmacovigilance system be put in place and that it is fit-for-purpose: Good Pharmacovigilance Practices (GVPs) Module I — Pharmacovigilance systems and their quality systems. In addition, the EU regulations require an EU Qualified Person for Pharmacovigilance” (EU QPPV) be nominated by the pharmaceutical company: this EU QPPV ensures that the company meets its legal obligations for the safety monitoring of all registered products.