The common technical document: the changing face of the New Drug Application.
Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority for approval. Although the requirements for this submission have similarities around the world, until now, the applications have been different. Regulatory authorities working under the umbrella of the International Conference on Harmonisation are hoping that the development of the Common Technical Document will soon harmonize the application procedure, and make this process simpler for applicants.
Molzon
Justina
J
International Programs of the Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, USA. molzonj@cder.fda.gov
D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000639:trends; D004282:Documentation / Q000639:trends*; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry / Q000639:trends; D007391:International Cooperation; D011643:Publishing; D014481:United States