FDA Data Standards Implementation Deadlines

FDA issued the most recent FDA Data Standards Catalog v4.5.1 dated August 31, 2016 to detail the “Supported and Required Standards” including standard versions, implementation dates and links to regulatory references. A few of the key deadlines that will affect our clients in the near future are as follows:

Electronic Submission in ICH eCTD Format

As of May 5, 2017, all NDA, BLA, ANDA and master file submissions to CDER and CBER must be in the International Council for Harmonisation (ICH) Electronic Common Technical Document (eCTD) format.

Animal Datasets

The DSC specifies that any animal data submitted to an NDA, BLA, ANDA, master file or IND must be in the Standard for Exchange of Nonclinical Data (SEND) format for the following submission types: 

1)     For NDAs, ANDAs, BLAs, and master files implementation began 12/17/2016.

2)     For commercial INDs, implementation begins 12/17/2017.

Clinical Datasets

Identical implementation dates to those for animal data are in effect for STDM and ADaM.

Contact RPI to ensure your readiness to meet FDA’s forthcoming requirements.

Submission of Manufacturing Establishment Information

In December 2016, FDA issued a draft guidance regarding the electronic format for submission of Manufacturing Establishment Information (MEI).

NDAs, ANDAs, BLAs, and amendments, supplements, or resubmissions of these application types will have to be submitted electronically in the format specified within the draft guidance twenty-four months after it is finalized.

FDA is proposing to mandate that applicants consolidate the MEI into a single list of information, in contrast to the current practice of filing MEI in multiple locations within a CTD. Highlighted requirements include:

• The MEI file must be included in eCTD Module 3, section 3.2.R Regional information.

• Applicants must name the file, “establishment-information-[Date of the submission (YYYY-139 MM-DD)].xml” with a corresponding leaf title of “Establishment-Information-[Date of the 140 submission (YYYY-MM-DD)].

• To avoid redundancy, the following “Manufacturer” sections must simply link to the single 3.2.R Regional file described above, and no other files may be submitted at these locations:
• 3.2.S.2.1 Manufacturer(s) [Drug Substance]
• 3.2.P.3.1 Manufacturer(s) [Drug Product]

Contact RPI to ensure your readiness to meet FDA’s forthcoming requirements. 

RPI Celebrates Submission of First Marketing Authorisation Application

Our regulatory staff's tireless efforts to prepare our first Marketing Authorisation Application (MAA) were rewarded this month by the acknowledgement of its timely and successful validation. RPI now has full capability to directly submit all eCTD submissions related to the authorisation and maintenance of medicinal products in Europe via EMA’s eSubmission Gateway. The use of the Gateway has significantly improved the EMA’s efficiency in handling the receipt of submissions, making them quickly available within the European Review System.

Find out more about how RPI can support your EMA submissions.

EMA Publishes Final Version of eCTD Module 1 Specification

Starting October 1, 2016, Version 3.0 of the European Union Module 1 electronic Common Technical Document (eCTD) Specification, released by the European Medicines Agency (EMA) will become mandatory.

The guidance document specifies Module 1 of the eCTD and implements several changes from Version 2.0, including:

●      additional submission types;

●      a new submission unit to further specify regulatory activities;

●      a Universal Unique Identifier (UUID) attribute to support automation;

●      and various changes to standard terminologies and values.

Committed to staying ahead of the curve, RPI has updated all eCTD tools to support these new technical requirements.

Contact RPI to ensure your UK and EU submissions meet EMA's guidelines.