XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website

1 September 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website.

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Biologic Lot Distribution Data must be submitted in SPL XML format within eCTD submissions

On June 10, 2014, the FDA issued a new rule which amended the requirements for biological LDRs. Under this new rule, applicants are required to submit LDRs to the FDA in an electronic format that the agency can process, review, and archive. This reporting requirement is effective as of yesterday, June 10, 2015.

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eCTD Module 1 specification Version 2.3 for USFDA

US FDA has announced new drug registration guidelines of pharmaceutical product for eCTD submission- Module 1 Specification version 2.3 and eCTD Validation Criteria, version 3.1

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Implementation of Thailand (Thai FDA) eCTD

The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptation of Pilot eCTD from October 2014 and authority has scheduled to receive the eCTD submission from May 2015.

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FDA Announces Fiscal Year 2015 Generic Drug User Fee Rates

The Food and Drug Administration (FDA) is announcing the rates for abbreviated new drug applications (ANDAs), prior approval supplements to an approved ANDA (PASs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees related to the Generic Drug User Fee Program for fiscal year (FY) 2015.

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