What does EDMF mean in FDA
EDMF stands for European Drug Master File. It is a document used by pharmaceutical companies to provide detailed information about the manufacture, storage and distribution of drugs that are being imported, exported or supplied within the European Economic Area (EEA). EDMF provides detailed technical, scientific and regulatory information about a drug product to the authorities responsible for its control. This includes safety information, such as quality control data, manufacturing processes and analytical methods. In addition, EDMFs can also contain clinical and non-clinical data related to the safety and efficacy of a product. By providing this information in an organized format, it helps ensure that drug products comply with applicable regulations in the EEA.
EDMF meaning in FDA in Governmental
EDMF mostly used in an acronym FDA in Category Governmental that means European Drug Master File
Shorthand: EDMF,
Full Form: European Drug Master File
For more information of "European Drug Master File", see the section below.
» Governmental » FDA
Meaning
The European Drug Master File (EDMF) is essentially a tool to help pharmaceutical companies comply with regulatory requirements throughout the EEA when importing, exporting or supplying their products within this region. It contains over 50 sections detailing technical, scientific and regulatory information related to a drug product – for example details on safety aspects such as quality control data; manufacturing processes; analytical methods and non-clinical/clinical data on safety and efficacy. All of this information is provided in an organized format to assist with assurance that the supplied product meets all applicable guidelines regarding safety and efficacy standards in the EEA.
Full Form
EDMF stands for European Drug Master File – a detailed document used by pharmaceutical companies to provide comprehensive technical, scientific and regulatory information about their drugs in order to ensure compliance with EEA regulations regarding safety and efficacy when importing, exporting or supplying a drug throughout the European Economic Area (EEA).
Essential Questions and Answers on European Drug Master File in "GOVERNMENTAL»FDA"
What is an EDMF?
The European Drug Master File (EDMF) is a filing system utilized by pharmaceutical companies to submit information and data on the quality, safety, and efficacy of active substances used in drugs. The EDMF system is managed by the European Medicines Agency (EMA) and regulated at the national level by authorities in Member States of the European Union (EU).
Who administers the EDMF system?
The EDMF system is managed and administered by regulatory agencies belonging to the European Medicines Agency (EMA).
Is there any additional documentation required to submit to an EDMF?
Yes. Depending on the type of submission, applicants must provide additional documentation such as summaries of quality data, pharmacovigilance reports, clinical trial results, or evidence of good manufacturing practices.
Are there specific requirements for submitting an EDMF?
Yes. Applicants must adhere to strict requirements when submitting an EDMF application. This includes providing detailed descriptions of drug characteristics, safety measures taken during development and production stages, effectiveness evaluation reports, and other necessary documents.
How often must an EDMF be updated?
Applicants are required to update their EDMFs annually or whenever significant changes have been made with regards to drug quality, safety, or efficacy.
How long does it take for a submission to be approved or rejected?
Once submitted, regulatory review bodies will typically take between two weeks and one month before making a decision about whether a submission should be approved or not.
Is there a fee associated with submitting an EDMF?
Yes. Submission fees may vary depending on the type of application being filed and whether it is subject to scientific advice. Fees also may vary from country to country within the EU.
Is all information provided through the EDMF confidential?
Yes. All information submitted through an EDMF application are held in strict confidentiality according to national laws across the EU Member States.
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