DMF, ASMF, CEP Submissions, eCTD, USFDA, EMA

Filing Active Pharmaceutical Ingredient (API)/Excipient information separately to Health Authorities (HAs) is not mandatory. However, to maintain the confidentiality and to refer for multiple drug product applications, as a practice, manufacturers of API/Excipient file the information as Drug Master Files (DMFs), Active Substance Master Files (ASMFs), and Certificates of Suitability (CEPs) aligning with region-specific requirements. Once API/Excipient information is filed with HAs and is accepted, same can be referred through Letter of Access (LoA) to multiple applications to avoid duplication of API information for different drug product regulatory submissions.

Regulatory submission requirements for API (Drug Substance)/ Excipient are very specific and different for every HA. Hence, expertise and experience in filing DMFs, ASMFs, CEPs, and active ingredient master files to global HAs help in quick approval of drug product applications. Freyr has very strong Regulatory team having expertise in handling new submissions to all major HAs like, the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the European Directorate for the Quality of Medicines (EDQM), the Therapeutic Products Database (TPD), the Pharmaceuticals and Medical Devices Agency (PMDA), the Therapeutic Goods Administration (TGA), Med safe, the Medicines Control Council (MCC), Ministry of Health (MoH) of Russia, Latin America (LATAM), Middle East and North Africa (MENA), Asia Pacific (APAC), Association of Southeast Asian Nations (ASEAN), Commonwealth of Independent States (CIS) regions, and World Health Organization (WHO).

With a strong footprint in handling all types of API/Excipient initial submissions to global countries including chemical and fermentation, sterile and for biologicals, Freyr proven to be a preferred Regulatory partner across the globe.

To evaluate the safety and suitability of information submitted with DMFs, HAs mandated that the DMF is filed using an electronic Common Technical Document (eCTD). Thus, the HAs can fast track the processing, reviewing, and archiving of submissions. Ensuring the same is practiced, the United States Food and Drug Administration (USFDA) has set forth deadline for DMF eCTD submissions, i.e. 05/05/2018, post which submissions will not be received.