Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 115

The operational issues involved in drug safety in the EU are far more complex and numerous than those in the US because of the multiplicity of member states and requirements. The regulation launched in 2010–2012 dramatically improved the consistency of requirements for post-marketing surveillance. The clinical trial PV requirements are markedly less harmonized than the post-marketing requirements at this writing, as specific national requirements are still in force despite the EU regulation.

Remaining in compliance with all of the ever-changing reporting requirements, new drug approvals, safety issues, and such in the 27 member states plus the EMA plus the affiliated countries presents enormous practical and logistical problems. The EU, like the US and Japan, is now undergoing and will continue to undergo changes in many aspects of AE reporting (electronic reporting, new risk management initiatives, drug dictionary, social media, smartphone app reporting, and “wearable” eHealth technology, etc.). The EMA and the member states are also becoming much more active in inspecting companies’ and vendors’ drug safety practices, both on a routine basis and on a “for cause” basis. The EU authorities conduct PV inspections within Europe and also abroad, which is a particularly important consideration, since inspections are used as a source of income and funding for health agencies.

In practice, what this means now is that any company that does studies or sells (or distributes) products within the EU must either have subsidiary or affiliated offices within the EU (and sometimes even within each country in which they sell or study). Failing this, the company needs to engage, with a written contract, a company (i.e., business partner or a contract research organization, CRO) to handle these functions for it. There must be an EU QPPV physically living and operating in the EU, and he or she must have direct and immediate access to the database (ICSRs, PSMF, PSURs/PBRERs, etc.) to deal with the EMA’s and individual member states’ queries and requests for information on marketed products. Language issues also oblige a company to be sure it has personnel who can deal with local HAs and others in the language of the country. The cost of doing business within the EU to handle all the regulatory requirements is high. Conversely, European companies wishing to do business in the US and in Canada must also open offices in these countries, though the US and Canada still have, to a large degree, “one-stop shopping” at the health agencies.

Finally, what will be required to continue to do business in the UK remains to be seen in the years after Brexit. Expect frequent changes.

We now give an example of one of the major EU member states’ drug agencies: France. This will give you an idea of what a large national agency may look like and handle in the EU.