La firma elettronica nel eCTD e lo standard SAFE

Una delle tipiche domande che ci si pone nel passaggio al mondo elettronico e quindi al eCTD è, come si fa per i documenti che richiedono una firma?

Nel “EU Module 1 Specification – Version 1.3 – May 2008” viene riportato chiaramente quanto segue:nella Table 1 Acceptable file formats for Module 1 "Documents should be generated from electronic source documents, any signature may be embedded as a graphic file in the PDF text if desired, although this is not necessary as the hard paper copy contains the legally binding signature."

e in altro paragrafo:

Use of Electronic Signatures
The use of advanced electronic signatures (digital signatures) will be crucial in achieving pure electronic communication between the pharmaceutical industry and regulatory agencies, particularly for authentication of electronic submissions and documents contained therein. The EU is therefore developing a long-term strategy to implement digital signatures. Currently however, the use of digital signatures for electronic submissions within the EU is not fully supported and digital signatures should therefore not be used. Please refer to individual national guidances for information on the use of electronic signatures.  

Nel documento “Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD electronic Submissions (NeeS) – Version 1.4 January 2008”, si riporta inoltre

 6.3 Electronic signaturesAlthough electronic signatures are currently accepted in the EU as being legally equivalent to handwritten signatures (Directive 1999/93/EC), some NCAs and EMEA require that certain specific documents (covering letters, Application Forms) are authenticated by separate signed paper copies. Please refer to each NCA for detailed guidance on this matter.

 

Passando al mondo FDA si trova una pagina dal significativo titolo “Important Information About Digital/Electronic Signatures”  che riporta:

FDA forms (e.g., 1571, 356h) and documents require a signature. Accepted signature methods by FDA are:
  • Scanned signatures
  • Digital signatures
  • Flattened digital signatures. A flattened digital signature must include (see example):
    • the printed name of the signer
    • the date and time when the signature was executed
    • the reason for signature

Please use the Adobe Acrobat Self-Sign plug-in to insert your signature on fillable FDA forms.  

Si nota che la signature nell'esempio riportato da FDA evidenzia un logo particolare con la scritta SAFE. SAFE è l’acronimo di “Signature and Autenthication For Everyone” e SAFE-BioPharma Association è l’associazione che dal Novembre 2003 “is the non-profit association that created and manages the SAFE-BioPharma™ digital identity and signature standard for the pharmaceutical and healthcare industries”.In conclusione, non esiste alcun obbligo sull’uso di electronic signature e lo standard che si affermerà in futuro probabilmente sarà quello indicato da SAFE. Su SAFE seguiranno degli approfondimenti specifici. 

 
 

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