The standard format for a drug product application in all markets is based on the Common Technical Document (CTD), where API information is included in part 3, section 2 entitled "Drug Substance." In addition, a Drug Master File (DMF) or Active Substance Master File (ASMF) submission procedure is required in most markets.
A DMF or ASMF is a submission of information by the holder of a drug or active substance master file in support of the drug product application. A DMF contains information pertinent to starting materials, manufacturing controls, manufacturing processes, characterization of the API, packaging and stability.
The DMF/ASMF procedure enables an active substance manufacturer to prepare and submit a dossier covering quality aspects of the substance. The pharmaceutical manufacturer refers to this master file when submitting a drug product application. The system allows confidential information on the active substance to be retained by the active substance manufacturer, as it is submitted directly to the authorities. At the same time, the applicant or marketing authorization holder can take full responsibility for the quality of the medicinal product.
In European countries the applicant wishing to market a medicinal product in more than one member state must obtain a marketing authorization either under the Centralized Procedure (CP), the Mutual Recognition Procedure (MRP), or the Decentralized Procedure (DCP). Under the CP, a single Community marketing authorization is issued; under the MRP or DCP, the terms of authorization are agreed upon by the competent national authorities that issue national authorizations.
For active substances included in the European Pharmacopoeia, a Certificate of Suitability (CEP), if granted, should be submitted rather than a DMF/ASMF.
In the United States (US), the applicant wishing to market a medicinal product submits an Investigational New Drug (IND) application or New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) application to the FDA. The DMF is submitted by the DMF holder to the FDA and is referenced by the applicant.
TAPI’s Regulatory Affairs (RA) department team is well trained and regularly updated on the regulatory requirements of many markets. TAPI DMFs are submitted worldwide, including in the US, Europe, Canada, Japan, Korea, Russia and China.
Our high-quality DMFs are prepared according to varying regional requirements and are tailored to meet the needs of the specific market submission. A ready-to-use database is available for immediate answers to common customer questions. More complicated customer requests are handled by the person specializing in that specific API. Deficiency letters are answered within the required period. Our goal is to provide customers with the best service possible in order to receive marketing authorizations on time.
Currently TAPI holds 275 US DMFs, 286 EU DMFs and 110 CEPs. This high number of submissions reflects the proven expertise of the TAPI RA team in the area of regulatory requirements. We continuously strive to learn from experience in order to improve our DMFs and optimize our product application processes for the benefit of our customers.