Wednesday, July 9, 2008

Regulatory Writing

One could say that regulatory writers (either freelancers or employees) may be the best paid in the medical writing industry. That is because their clients/employers are usually pharmaceutical companies with lots of cash.

What do regulatory writers do? They prepare documents that need to be submitted to regulatory agencies such as the Food and Drug Administration (as well as clinical trial reports and investigator brochures). Here's a description of some of these regulatory documents.

Investigational New Drug Application (IND)—the company requests permission to test a drug in humans. The IND includes scientific information about the chemical composition of the drug, an overview of previous animal studies, and whether the drug has been used in humans overseas. If the drug has been tested overseas, a complete summary of all efficacy and safety information to date also needs to be submitted.

New Drug Application (NDA)—the company has completed its research in humans and now submits the results in the NDA. This comprehensive document contains data on the effectiveness and safety of the drug obtained during preclinical and clinical trials.

Common Technical Document (CTD)— in the early 1990s, regulatory authorities and experts from the pharmaceutical industry from Europe, Japan, and the United States created the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH seeks to harmonize the interpretation and application of technical guidelines and requirements for product registration to avoid the duplication during the development of drugs in every region. As a result of this harmonization came the CTD, which includes information on how the product is administered and prescribed and other documentation on the drug’s quality, safety and efficacy. The CTD was designed for use in Europe, Japan, and the United States.

Marketing Authorization Application (MAA)—the company submits an application requesting marketing authorization of the drug in the European Community, which includes chemical and clinical data on the drug.

Regulatory writing is not for everyone. Usually you need an advanced degree to break in. But if you like it and are good at it, you're in for a rewarding job.

3 comments:

Tim Rosa said...

Yes, this is a good general introduction to medical writing. It would be nice to see links to more specific resources for additional information.

Tim

SG said...

What should be the basic qualification for a regulatory writer? Is a pharma or medical degree essential?

Deepak said...

Symogen Ltd offering full and and very customized support for safety department. Medical Writing