Decode the Health Canada, and US FDA new DMF Submission Mandates

Are you a DMF holder willing to submit your paper Drug Master Files (DMFs) to Health Canada? Or are you looking for a paper DMF submission partner?

Either the case, we suggest you to call-off all your paper DMF submission efforts immediately. Because, the Health Canada (HC) is no longer accepting paper copies of DMFs. From now on, the agency will accept the DMF submissions in ‘non-eCTD electronic only’ format.

Referring to the Health Canada’s notice published on October 5, 2015, it is to be understood that in order to enable effective record management and ensure authenticity, integrity, availability, traceability and non-repudiation of the data, the agency is all set to accept DMFs in ‘non-eCTD electronic only’ format.

The proposed regulation – HC’s ‘non-eCTD electronic only’ – is going to be implemented in two phases. As part of the first phase, which is in effect since January 1, 2016, Health Canada has already stopped accepting paper copies of DMF transactions. Organizations that still go ahead to submit paper DMFs will have to face their submissions returned at their own expense.

In the second phase, scheduled for March 31, 2016, HC is expecting to receive the complete electronic copy of the DMFs in ‘non-eCTD electronic only’ format. For which, organizations must convert all their paper DMFs to electronic and submit the same to HC in a requested format. Failing to do so, organizations will have to face the consequence of DMF suspension that may end up with no further access to existing DMFs, both to review and to update.

What to submit?

As per the HC’s notice, organizations should submit the following in ‘non-eCTD electronic-only’ format, with an immediate effect:

  • new Drug Master Files
  • transactions related to existing DMFs (for example, letters of access, administrative information)
  • DMF updates (the first update must include a complete DMF conversion in “non-eCTD electronic-only” format for the existing DMF in paper format)

Which format to submit? ‘Non-eCTD electronic only’ or ‘eCTD’?

As per the Health Canada’s DMF submissions mandate, it is clear that organizations will have to turn to ‘non-eCTD electronic only’ format. But what if organizations submit a DMF for the same product to different agencies that accept eCTD submissions? In such scenarios, HC facilitates the option to submit DMFs in eCTD format as well to avoid challenges while creating/preparing the same application in alternate formats, provided the below requirements are met:

  • a sample as per eCTD guidelines must be provided to HC prior to filing a DMF in eCTD format
  • for companies using eCTD for the first time, a pre-technical meeting is recommended which is mandatory for DMF Type II and III
  • a Dossier Identifier should be requested for all DMFs filed in eCTD format.  The request should include a fully completed DMF application form
  • DMFs provided in eCTD format must be sent via the Common Electronic Submission Gateway (CESG)

Which agency to submit? Health Canada / US FDA?

Besides Health Canada’s electronic DMF mandate, the US FDA’s DMF eCTD submission mandate is also set to come into effect on May 5, 2017. As deadlines draw nearer, understanding both the agencies’ DMF submission requirements would be challenging. To enable organizations easily understand mandate requirements, here we provide a table that will demystify DMF submissions for both Health Canada and US FDA.

Agency Mandate Deadline Submission Type Requirements
Health Canada January 1, 2016 Non-eCTD electronic only or eCTD All existing DMFs in paper format must be replaced by a complete DMF conversion in [electronic] format
March 31, 2016
US FDA May 5, 2017 eCTD Resubmitting previously submitted information is not required when converting an existing DMF

With the information sourced, it seems that each agency’s DMF submission mandate varies with that of the deadlines, submission formats, and conversion requirements. While navigating through these variations, what DMF holders shall really look for is their existing internal practices of information management to streamline paper to eCTD conversions.

If paper DMFs are already organized in CTD format, DMF holders must ensure:

  • appropriate level of granularity is used in eCTD submission documents
  • content is optimized for eCTD submission
  • documents conform to FDA’s PDF specifications and/or HC’s technical requirements

If paper DMFs are not already organized in CTD format, DMF holders should:

  • reorganize/re-author content to fit the required eCTD format

In Conclusion:

With Health Canada’s mandate already in effect and US FDA’s mandate just 17 months away, lack of knowledge on paper to eCTD conversions and eCTD submissions may put your DMF submission compliance efforts at risk and may prove costly too. To avoid last minute challenges, it is advised to start working towards the compliance right now.

To navigate your organization through this complex compliance process, Freyr offers the best of both worlds – on-demand eCTD submission solution, Freyr SUBMIT as well as a Centre of Excellence that offers best in class, cost-effective and custom eCTD outsourcing service models built around clients’ unique and demanding requirements.

 

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