Registration process has been harmonized by adoption of WHO-ICH recommended Common Technical Document
(CTD), ensuring that the current Good Manufacturing Practices (GMP) are followed strictly by the manufacturers of the drugs, conducting WHO National Regulatory Authority assessment and Pharmaceutical Inspection Corporation/Scheme (PIC/S) membership process has been started.
The NDA is being finalised in Electronic Common Technical Document
(eCTD) format and will be submitted to the FDA following electronic publishing activities and technical document validation, the company explained.
StartingPoint 4.0 is designed to offer standardized templates and formatting functionality to those authoring the various components of a CTD (Common Technical Document
) or eCTD (electronic Common Technical Document
) regulatory submission.
The sNDA was the company's first submission in the electronic common technical document
(eCTD) format now required by the FDA.
"Certainly ICH is taking on some of that already, in the form of the common technical document
," Peterson said.
New initiatives in drug registration process including international quality CTD (common technical document
) format for drug Registration dossier, 2D bar-coding on labeling, mandatory Good Manufacturing Practices (GMP) certified source of raw materials of API (Active Pharmaceutical Ingredients) and excipients, standardization of drug specification, etc, are worthy efforts of DRAP team to ensure the provision of quality drugs.
The launch of the platform will be followed by subsequent releases of business modules that provide functionality to support submission standards such as eCTD (electronic Common Technical Document
) and CDISC (Clinical Data Interchange Standards Consortium) and complex activities relating to these standards such as global submission publishing, compilation and lifecycle management.
The ICH defined a process by which this standardization would occur, and in November 2000 the ICH Steering Committee met in San Diego, CA to ratify the guidelines describing the Common Technical Document
for the Registration of Pharmaceuticals for Human Use (CTD).
CTD (Common Technical Document
) is now standard worldwide for drug registration dossier format.
She said, 'Common Technical Document
(CTD) is now standard worldwide for drug registration dossier format.
He said that in order to further strengthen pharmaceutical registration system, DRAP will start receiving registration applications on Common Technical Document
format in early 2017.
To elucidate the current status of the use of animal models for nonclinical safety assessment, an internal questionnaire from the Japan Pharmaceutical Manufacturers Association and surveys (questionnaire period: August 27 to September 30, 2015) of both common technical documents
and review reports of approved drugs (approval period: May 1999 to May 2017) disclosed by the Pharmaceutical and Medical Devices Agency were conducted.