Electronic submissions from drug companies to Health Canada will soon be extra streamlined.
To see this through, the Canadian regulatory agency will be employing the docuBridge system from Mississauga, Ont-based Lorenz Newbook Inc. for their Electronic Review project — used to electronically review product submissions from drug companies.
The new system will be tested in a pilot project starting on June 30th and will run for “a couple of years,” according to Marilyn Schwartz, director, submission and information policy division, Health Canada.
She said the submission process is presently done in a paper format.
“One submission could be 100 to 800 three-ring binders,” said Schwartz. “What the electronic environment does is replace the paper with CDs and DVDs.”
She added the drug companies must be able to submit the applications electronically.
“We’re hoping that if we approve the drug in a more streamlined manner it’s going to benefit everybody in the end.”
Schwartz noted Health Canada is still in the process of training and adapting to the electronic environment.
The docuBridge system has two components, said Charles Mathis, chief technical officer, Lorenz Newbook.
“One is a validation component which will be used to validate the incoming electronic submissions,” he said. “The second is a review tool which allows the viewers to review submissions, make notes, annotations, and bookmarks because submissions get quite large.”
He said they could easily have thousands of documents, hundreds of thousands of pages, and many gigabytes of data.
Schwartz said the docuBridge system will be used primarily as a viewing tool to see the submissions from the drug companies.
“It will be easier to navigate and review the submission in the actual CTD (common technical document) format, and it’ll be able to have better life cycle management of the submission,” she said. “They’ll be able to reuse the data in a more timely and cost-effective manner.”
Because Health Canada requires products be available in both French and English, Mathis said Lorenz will be translating the entire program interface and associated documentation into French.
Schwartz said there’s many staff involved in the project including business analysts and reviewers that are working towards ensuring the tool is adapted to their requirements and to be able to use it as efficiently as possible.
She noted that the Lorenz tool is just one small part of the whole E-review project.
“There are other systems we’re using…it’s a culture change because it’s changing the way we do things, moving from paper to electronic so it is a big management change of processes and procedures,” Schwartz said.
Health Canada anticipates implementation of the new system to be complete and operational by 2007.
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