Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 120

Q: Is it likely that the EU, the US, and the rest of the world will “settle down” and stabilize their rules and regulations anytime soon?

A: Probably not. There are several factors at work. First, the entire world of drug safety and risk management is in a state of flux. New technology (e.g., social media, smartphone medical apps) and regulations are being put in place as a result of many influences, including the following:

Consumer awareness;

Political pressures and globalization;

Economic pressures and outsourcing;

Changes in the structure of HAs (e.g., the may expand beyond its current 27 members);

Critical safety issue(s) that have caused product restrictions or withdrawals; and

Capacity limitations of governments.

The changes would be aimed at making each member state requirements 100% consistent with the clinical trials regulation and ICH E2A. Another change would remove some of the ambiguity in the causality determination requirements for SUSARs. Currently, the investigator or sponsor makes causality determinations, though this is often difficult to do for any particular individual case. The EU may move toward requiring the sponsor to consult with the investigator to determine a possible causality. If there is disagreement between the sponsor and investigator, then the submitted SUSAR must contain both causalities.

It is not clear that collective, global organizations will be any more effective in drug safety as they are in limiting arms proliferation, wars, or climate change.

Another point to note is that a decade or two ago, the major PV players were the US, the EU, and Japan. Since then, we have major new players gaining more and more influence (e.g., China and India) as well as the “discovery” of PV by most of the remaining 100 plus countries of the world on all five continents. Many countries are putting forth PV requirements, usually in their own languages, based largely on ICH and CIOMS though sometimes following EU procedures more or less. The emphasis here is on “more or less” and regional requirements are often introduced. Many of the new players have individual differences and quirks in their requirements which make PV compliance in all markets very challenging.

Q: Does one need to know any other languages besides English if one is doing PV?

A: A delicate question. Obviously, in countries where English is not the official language, one must know the language of that country. Often, some documents, cover letters, local cases, e-mails, and other requirements must be prepared in the local language. In addition, governmental officials, patients, healthcare workers, and company employees are more comfortable in their native language. Some medical terms do not translate well language to language. Having said that, the “official” language of drug safety is English (as much as there can be an official language) and nearly all international documents (e.g., PSURs/PBRERs) are done in English. However, local submission of English language documents often require summaries in the local language. At a high level and on the international scene (ICH, WHO, CIOMS), the main, or often only, business language is English. Thus, one can often survive rather well knowing only English, but more opportunities are available for those with linguistic skills. As noted earlier, there may be a push to use French and German as well as other languages in the EU now that the UK is leaving.

Q: Considering the EU regulations which will likely continue to change in the coming years, how can we ensure that we are up to date on the new/latest documents?

A: Obviously, one must pay attention to changes in requirements in all countries and markets where one does studies or markets drugs (or has business partners). There are various ways to do this depending on the size of the organization you are working in. Within large pharma companies, dedicated employees identify and analyze new EMA and national documents. This is often called “regulatory intelligence”. These people sometimes also perform impact analyses of the new requirements.

At the very least, one should periodically review the EMA website as well as other important websites (e.g., EudraVigilance) and the national agencies’ websites.

Small and mid-size companies may not have specific personnel devoted to such a task or to regulatory intelligence. For these companies it may be wise to hire a vendor that specializes in regulatory tracking. One may also attend the periodic meetings that EMA and some national health agencies hold to update the pharma companies. Some private and academic organizations (e.g., the Drug Safety Research Unit (DSRU) in the UK, The DIA, also holds periodic meetings).

¹Peter Arlett et al., Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee, Nat Rev Drug Discov 2014; 13: 395–397.