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What does it mean for Drug Approval Processes?
Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
The latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap.
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines o
When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered.
Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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