eCTD, EMA, Health Canada, Regulatory Update

Regulatory Updates: European Electronic Application Form and Health Canada eCTD Mandate

Joel Finkle, Director Regulatory Innovation and Donald Palmer, Director Product Strategy

A couple of announcements have been received from regulatory agencies impacting product application processes.

European Electronic Application Form (eAF)

First, EMA has updated the electronic Application Form (EAF). This is the interactive PDF form from which EMA extracts an XML representation of what your eCTD submission is all about. Version 1.21 will become effective as of June 20, 2017. Changes include:

  • For human medicines:
  • The ability to identify more than one device – previous versions only permitted a single device
  • A new free-text field permitting CHMP (Committee for Medicinal Products for Human Use) Details to be entered
  • For veterinary medicines
  • A checkbox was added to indicate whether Maximum Residue Limit (MRL) information is provided – previously the fields were just present in all applications.
  • The ability to list multiple “other provisions” instead of just one entry
  • A new free text field permitting CVMP (Committee for Medicinal Products for Veterinary Use) Details to be entered

These should have no impact on your current operations in ARIM, although the additional fields may need to be filled in when you create your electronic Application Form.  Future versions of ARIM may be capable of filling out the eAF automatically.

Further information may be found on the EMA webpage.

Health Canada eCTD Mandate

An announcement came from Health Canada that doesn’t have any new information – dates have not changed – but all the information on their mandate for eCTD is in one place:

As of January 1st, 2018, the following regulatory activity types, as well as all additional information and subsequent regulatory activities/transactions (as per section 1.3 of the Guidance Document Preparation of Drug Regulatory Activities in eCTD Format) for human drugs, must be filed in eCTD format:

  • New Drug Submission (NDS);
  • Supplement to a New Drug Submission (SNDS);
  • Abbreviated New Drug Submission (ANDS); and
  • Supplement to an Abbreviated New Drug Submission (SANDS).

Regulatory activities for the following are recommended, however, not mandatory for filing in eCTD format:

  • Master Files;
  • Clinical Trial Applications (eCTD CTA pilot only);
  • Drug Identification Number (DIN) Applications and Post-Authorization Division 1 Changes (PDC) for Human drugs.

Regulatory activities for the following currently remain out of scope for filing in eCTD format; they must be filed in “non-eCTD electronic-only”:

  • Medical Devices;
  • Veterinary Drugs.”

This puts Health Canada very much in alignment with the US Food and Drug Administration mandate, although about six months slower, and with no requirement for Master Files or Clinical Trial applications.

If you are already an ARIM or ARCS customer, you’re good to go. If not, please contact us for more information on how we can help you stay compliant and lower costs.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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