First Time Right Filing June 2016
Many large and medium biopharma companies operate in 100+ countries. It’s highly challenging to meet regulatory requirements for product approval of new and generic drug fillings, assuring regulatory compliance, and maintaining lifecycle of regulatory authorizations and established guidelines in these countries.
Major changes in Labeling Regulation coming up in 2016
2016 hopes to be a very happening year as far as rule making for drug labeling. Various regulations are expected in this year by regulatory agencies. To whatever the extent, the most important change would be labeling regulations of generic drugs by the drug major United States of Food and Drug Administration (USFDA).
Common Electronic Submission Platform
After public consultation, The European Directorate for the Quality of Medicines & HealthCare (EDQM) has laid down its roadmap for the submission of Certificate of suitability of Monographs of the European Pharmacopoeia (CEP) in electronic format for the next 4 years. This roadmap presents a major change to current practices.
CDER CBERs eCTD standard format Jan 2017
The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions.Beginning May5, 2017 submission type NDA, ANDA,BLA and Master Files must be submitted in eCTD format.Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018.
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