WorldWide Regulation

TAPI’s high standards of quality and industry-leading compliance are designed to ensure our products meet stringent requirements worldwide.


TAPI: Your Global Regulatory Partner

TAPI’s Regulatory Affairs (RA) team is highly professional and has many years of experience with submissions in several regulatory markets. The RA group stays up-to-date on global regulatory requirements. TAPI DMFs are submitted worldwide including in the US, Europe, Canada, Japan, Korea, Russia, and China.

The Application Process

In main regulatory markets, the standard format for a drug product application is based on the Common Technical Document (CTD), where API information is included in module 3, section 2 entitled "Drug Substance." A Drug Master File (DMF) or Active Substance Master File (ASMF) submission procedure is also required in most markets. DMF or ASMF content is equivalent to CTD Module 3 for drug substance.

The holder of a drug or active substance master file submits a DMF or ASMF in support of a drug product application. A DMF includes CMC information (Chemistry, Manufacturing and Controls) about the API, e.g., the detailed manufacturing process, starting material controls, manufacturing in process controls, characterization of the API, packaging, and stability data.

The DMF/ASMF procedure enables an active substance manufacturer to prepare and submit a dossier detailing the 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.

Applying in Europe

When planning to market a medicinal product in more than one member state, you 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.

Applying in the United States

When planning to market a medicinal product in the US, you must submit an Investigational New Drug (IND) application or a New Drug Application (NDA) / Abbreviated New Drug Application (ANDA) to the Food and Drug Administration (FDA). The DMF holder submits the DMF to the FDA which is referenced by the applicant. For generic applications, under the generic Drug User Fee Amendments of 2012 (GDUFA), DMFs available for reference are listed on the public FDA website.

Our goal is to provide you with the best service possible so you receive approval on time. Our high-quality DMFs meet regional requirements and are tailored for specific market submissions. A ready-to-use database is available for immediate answers to common questions. More complicated requests are handled by the relevant TAPI expert who specializes in that specific API. If a deficiency letter is issued by the authorities, TAPI RA is fully committed to supporting you with timely and quality responses.

TAPI currently holds more than 300 US DMFs, 300 EU DMFs and 155 CEPs. We always look for ways to improve our DMFs and streamline the product application process to benefit you. Our RA team’s expertise in regulatory requirements is an advantage, and a reason why the industry’s top global pharma companies trust TAPI.