A Drug Master File (also known as DMF) is a submission type that is used to provide confidential detailed information, such as facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs, to the appropriate regulatory authority.
While DMFs were usually submitted with none electronic submissions, recent development of regulatory authorities requires (or will require in future) to submit DMFs in eCTD format (electronic common technical document). Such requirements usually comes with the strict deadlines like most types of DMFs. For full US FDA guidance on electronic submissions please follow the link. Failing to submit your drug master files in eCTD could lead to failure of reaching customers due to suspended providers licence on that specific drug.
Were you ready to submit your Drug Master Files (DMFs) in the eCTD format by 5th of May 2020? If not, we are here to help. Being ready means making sure your documents are properly prepared (bookmarked, OCR’d, proper orientation), you are able to create your baseline DMF submission as eCTD, and establishing your connection to the FDA (USA) via the Electronic Submissions Gateway (ESG). The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports… no exemptions, no waivers!
Phlexsubmission is built for this purpose and manages DMFs quickly, easily and with 100% of compliance!
Are you looking for the best software solution to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia Applications (CEP software) in eCTD format? PhlexSubmission is built to help you prepare and submit your CEPs. A secure and easy to use solution that can get you started today. And our global Client Success team guarantees 100% eCTD compliance for your first CEP submission!
Were you ready to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia (CEPs) in the eCTD format by January 1st 2020? According to the European Directorate for the Quality of Medicines & HealthCare (EDQM) – the organisation responsible for the procedure of CEP – in order to receive EDQM Certificate submissions for CEP must be in the eCTD format beginning the 1st of January 2020.
The mandate applies to:
About CEP submission
CEP or Certification of Suitability to the Monographs of the European Pharmacopoeia is the certification confirming that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the European Parliament.
Scope of the CEP:
CEP application in eCTD format contains 3 modules:
Upon receipt, the application is validated and listed for assessment. After assessment, the EDQM may send queries to the applicant. When they are resolved, the EDQM sends the applicant a CEP certificate, which is valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal.
CEP application is open to any manufacturer regardless of region they are based at. CEPs are accepted in 36 Member States of the European Pharmacopoeia Convention + EU, Canada, Australia, Singapore, South Africa, etc.
If a company which has been granted a certificate of suitability (EDQM’s CEP) may wish to apply for another CEP for the same substance, either when it is not possible to apply for a revision of the initial CEP or when the company wishes to have separate CEPs for different conditions of preparation or qualities, they can submit a new application as a “sister file”. This new application should fulfill the conditions listed in the guideline for sister files.