Drug Master Files – Preparation and Maintenance
By necessity, and for the common good, the pharmaceutical industry is closely regulated. Consequently, suppliers to the pharmaceutical industry should be knowledgeable about the regulatory requirements to which the industry is subject. The operating environment for pharmaceutical companies is getting more and more difficult, with a tightening regulatory framework, increasingly demanding quality standards. Health regulatory bodies emphasis on DMF was very obvious choice since health industry was changing tremendously with passing of major laws in various countries in order to provide better drugs.
Realizing this, the main purpose of this research study is to provide information on the regulatory scheme applicable to DMF preparation and its maintenance. It also aims at bringing out the importance of a drug master file and the current scenario in pharmaceutical industry. Technical contents of a DMF, forms the heart of this research study. Common deficiencies associated with a DMF and regulators’ expectations have also been highlighted. The entire thesis revolves mainly around the DMFs procedures and regulations followed in US Market. But other major country regulatory guidances such as EU, Canada have also been briefly discussed. Formatting and presentation of data of a DMF in CTD format has been described and emphasized upon. The emerging scenarios of developing countries like India and China in DMF market also has been briefed highlighting challenges faced by these countries and ways to tackle them. ROLE AND IMPORTANCE OF DMF
Role of Drug Master files.
Submission of all information required for any product application is the responsibility of the drug manufacturer; however, in many cases, information on materials used in the production or packaging of drug product, such as the formulation of a packaging material or the production of an API, is considered by the supplier to be confidential trade secret information. Consequently, the drug Master Files (DMF) system was developed to permit suppliers to make this information on their products directly available to Health authorities for its review of drug company applications that involves the use of the suppliers material.
What is a Drug Master File
A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.
The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. The DMFs are te first step in the process to launch a generic drug in the US market
Why make a Drug Master File
A DMF is NOT a substitute for an IND, NDA, ANDA, or Export Application. It is not approved or disapproved. Technical contents of a DMF are reviewed only in connection with the review of an IND, NDA, ANDA, or an Export Application.
DMF's are generally created to allow a party other than the holder of the DMF to reference material without disclosing to that party the contents of the file. When an applicant references its own material, the applicant should reference the information contained in its own IND, NDA, or ANDA directly rather than establishing a new DMF.
The term Drug Master File (DMF) is commonly used to describe a submission to a competent authority that may be used to provide certain confidential detailed information about facilities, processes or articles used in manufacturing. In Europe, such confidential information can be submitted in a so-called “Active Substance Master File (ASMF)” using the European Drug Master File procedure. It should be noted that there is a difference between the content and format of Drug Master Files used in...
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