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Gesetzliche Regelungen zu elektronischen Unterschriften bei der Einreichung von Zulassungsunterlagen für Arzneimittel

Vergleich zwischen der FDA-Richtlinie 21 CFR Part 11 und der EU-Gesetzgebung

Dr. Stefan Hock und Till Jostes

CSC Ploenzke AG, Wiesbaden

Legal Regulations on the Electronic Signature Concerning the Submission of Drug Applications / FDA Guideline 21 CFR Part 11 compared to EU legislation

Regulatory authorities around the world require pharmaceutical companies to submit huge amounts of information to support the submission procedures, or the maintenance of such submissions, respectively. Up to this stage, pharmaceutical companies as well as the regulatory authorities have invested significantly in information technologies. In this process, the Internet is playing an increasingly important role. Electronic signatures are a decisive feature for a reliable and secure exchange of information via the Internet and must therefore comply legal requirements such as the Good Manufacturing Practices (GMP) or the law 21 CFR Part 11.
Basically, according to 21 CFR Part 11 one must distinguish between closed and open systems, a distinction, which is not reflected in the EU legislation. This impacts the imposed control requirements and procedures in various different ways. In the course of the European legislation, the European Union as well as the member states have by now passed various laws and regulations. However, unlike 21 CFR Part 11, most of these laws do not relate directly to the pharmaceutical industry, but to general requirements of electronic business transactions.
To sum up the above, it can be said that there are different legal approaches between the USA and the EU as well as between the individual member states. It would therefore be advisable to analyse the business processes under the aspect of what is „formally required“ of the signature, to plan the technical implementation on the basis of the legal framework, and not to consider the concrete requirements until the actual implementation.

Key words 21 CFR Part 11 · Compliance · Elektronische Signatur · Elektronische Unterschrift · Europäische Regelung · Geschlossene Systeme · GMP · Offene Systeme · Public Key-Infrastruktur, PKI-Struktur · Trust Center