Active Pharmaceutical Ingredients (#APIs) are the core components of any drug, contributing directly to the treatment or prevention of diseases. The #quality, #safety, and #efficacy of APIs are of paramount importance, necessitating stringent regulatory oversight. In Europe, this is facilitated through a process known as Drug Master Filing (#DMF).
A Drug Master File (DMF) is a confidential, detailed document submitted by API manufacturers to #regulatory authorities. It contains comprehensive information about the API, including its manufacturing process, quality control #procedures, #packaging, and #storage. DMFs enable regulatory authorities to review this information during the approval process of the #drug.
In #Europe, the European Medicines Agency (#EMA) oversees the DMF submission process. The EMA requires the submission of an Active Substance Master File (#ASMF), previously known as a European Drug Master File (EDMF), for APIs.
âž¡ The ASMF comprises two main parts:
#Applicant’s Part (#AP): Contains non-confidential information about the API that can be shared with the drug product manufacturer. It includes details about the substance’s general properties, manufacturing method, and control of critical steps and intermediates.
#Restricted Part (#RP): Contains confidential information that is not shared with the drug product manufacturer. It includes detailed information about the manufacturing process, validation, and control of materials.
âž¡ The ASMF procedure involves the following steps:
#Preparation: The API manufacturer prepares the ASMF in accordance with the EMA’s guidelines.
#Submission: The ASMF is submitted to the EMA and the relevant National Competent Authorities (#NCAs). The API manufacturer also provides the drug product manufacturer with the AP.
#Assessment: The EMA and NCAs assess the ASMF as part of the evaluation of the Marketing Authorization Application (#MAA) submitted by the drug product manufacturer.
#Updates: Any changes to the API or its manufacturing process must be updated in the ASMF and submitted to the EMA and NCAs.
âž¡ The DMF process plays a crucial role in ensuring the quality, safety, and efficacy of APIs. It facilitates transparency between API manufacturers, drug product manufacturers, and regulatory authorities, ultimately safeguarding public health. As such, understanding and correctly implementing this process is vital for API manufacturers seeking to enter the European market.
#FWQRC-GxP & Regulatory Consultant plays a vital role in supporting companies to achieve and maintain compliance, ensuring patient safety and product quality.
#Consultancy Services: FWQRC-GxP provides expert guidance on #GMP compliance, regulatory affairs, and quality management.
#Regulatory Submissions: Prepare and submit regulatory documentation.
#Continuous Improvement: Foster a culture of quality and continuous enhancement.
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