Over the past several years, the number of dossiers being submitted in electronic Common Technical Document format has increased in both the United States and the European Union.
As such, pharmaceutical companies should understand this format.
The electronic Common Technical Document is a format used to submit information on the quality, safety, and efficacy of a pharmaceutical or biologic to an agency for approval.
In 2008, it became the standard format accepted by the Center for Drug Evaluation and Research and the Center for Drug Evaluation and Research.
Although the electronic Common Technical Document is not required for submissions in the United States at present, the Food and Drug Administration announced in 2009 that it will become the standard format in the future. As such, agencies such as the Food and Drug Administration encourage companies to use this format to submit drugs and biologics for approval.
The electronic Common Technical Document contains five modules. The first module consists of regional administrative and prescribing information and is specific to a region. The other four modules are not region specific.
Module 2 includes overall quality summary, nonclinical overviews and summaries, a clinical overview, and clinical studies. In Module 3, information on the quality of the product is included. Nonclinical and clinical study reports are included in Modules 4 and 5, respectively.Continue Reading
With the increased use of electronic submissions and documents in electronic format, pharmaceutical companies should understand the regulations that pertain to them.
Twenty-one Code of Federal Regulations Part 11 is the section that deals with the use of electronic records, electronic signatures, and handwritten signatures committed to electronic format. It consists of Subparts A, B, and C.Continue Reading
As manufacturers of pharmaceutical products, pharmaceutical executives must know the appropriate guidelines governing the manufacture of packaging and labeling.
These requirements are stated in 21 Code of Federal Regulations Part 211.Continue Reading
The FDA Group's Larry Stevens is quoted in an article in Assembly magazine:
How to Respond to FDA Form 483
"It got lost in the mail" is an age-old excuse that some people use to deal with bills and other bad news that arrives in their mailbox. But, if the envelope is from the U.S. Food and Drug Administration, it’s not a good idea to play dumb or act indifferent.
No medical device manufacturer wants to get a Form 483 or a Warning Letter from the FDA. However, if it does happen, manufacturers must take every possible step to address the issue.
While FDA Form 483 has been around for decades, there’s been an increasing amount of incidents in recent years. And, 483s and Warning Letters are becoming increasingly rigorous and complex.
In order to market a device in the United States, manufacturers must gain approval from the Food and Drug Administration (FDA).
However, the approval process for devices can be complicated and determining which approach to use can be challenging for manufacturers.
As such, it is important for manufacturers to be familiar with the regulatory structures and processes that through which medical devices are approved.Continue Reading