Digital standard could cut approval times
has agreed on an electronic data standard that should make it
easier to file product approval dossiers to regulators
electronically, bringing drugs to market more quickly, writes
Phil Taylor.
The standard, based on a Public Key Infrastructure (PKI) format, could in time be used across other sections of the industry, according to the Secure Access For Everyone (SAFE) coalition. SAFE was formed last year under the aegis of US industry group the Pharmaceutical Research and Manufacturers of America (PhRMA).
The move echoes the actions of the banking industry, which has adopted its own digital standard to allow secure transactions between companies and institutions. SAFE estimates that adoption of the standard could save the industry around $200 million (€166m) a year.
The PKI will initially be used to standardise the enormous amount of data required by regulators to approve drugs, and do away with the need for each company to use a different system to identify itself electronically. This is a headache for agencies, which have difficulties ensuring the authenticity of filed data.
The standard is a system of hardware, software, people and processes to provide a secure digital environment to issue, revoke, archive and recover digital certificates. Aside from regulators, it could also allow secure transfer of data between companies and clinical researchers, or indeed any form of internal data with external collaborators.
It will provide an electronic format that should be safe, legally enforceable and allow electronic signatures as governed by the US Food and Drug Administration's 21 CFR Part 11 legislation, according to SAFE. The coalition presented its standards - currently some 18 technical documents encompassing more than 500 pages - at the BIO 2004 conference.
The driving force behind SAFE and the new standard is SEBiX, the Secure Electronic Biopharmaceutical Information eXchange, led by Pfizer's executive director of worldwide regulatory affairs, William Rosen.
Rosen believes the answer to the electronic submissions problem is to set up a vendor-neutral body - much like a stock exchange - that would be charged with the receipt and transfer of electronic data. A pilot study, using a document (Form 1572) that is commonly filed to the FDA, found that this clearinghouse approach was feasible. The agency receives 120,000-150,000 of these forms every year.
SAFE has the following members: Abbott, Aventis, Amgen, Bristol-Myers Squibb, Covance, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer, Procter & Gamble, the PhRMA, the European Federation of Pharmaceutical Industry Associations (EFPIA), the FDA and the European Medicines Agency (EMEA).
