Changes to Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)



Changes to Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)


Posted: Monday May 8th, 2017

Article by: Madhur Jadawala, Lead Consultant, Quality & Compliance Services Inc.

Health Canada on February 10, 2017 has issued a notice outlining changes to the submission filing requirements pertaining to Good Manufacturing Practices (GMP)/ Drug Establishment Licences (DEL). These changes are effective immediately for drug submissions filed after the date of this notice (February 10, 2017).

Regulations

Pursuant to Sections C.08.002(2)(e ), C.08.002.01(2)(b), C.08.002.1(2)(a) and C.08.003(2)(e) of the Food and Drug Regulations a new drug submission (NDS), an extraordinary use new drug submission (EUNDS), an abbreviated new drug submission (ANDS), an abbreviated extraordinary use new drug submission (AEUNDS), or a supplement to any of these submissions, shall contain “details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug ”. The “controls” include those which ensure GMP, and which are required in order to be in compliance with Division 1A (Establishment Licences) and Division 2 to 4 (Good Manufacturing Practices) of the Regulations.

Background

Historically, the Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada has required that buildings performing licensable activities to be GMP compliant. If this requirement was not fulfilled, deficiency letters were issued to the sponsors. As a result, sponsors of drug submissions had to plan strategically when it came to the anticipated drug submission filing date because the DEL Unit’s service standard for processing DEL applications/amendments is 250 calendar days. In the worst-case scenario, the sponsor received a deficiency letter from TPD and had limited time (anywhere between 7 – 45 days) to respond to this deficiency for providing the evidence of GMP compliance. Now as mentioned above, the DEL unit takes about 250 days to process an application or amendment and hence the sponsor, by no means, can respond to this deficiency satisfactorily in the limited time provided by the TPD. Therefore, having appropriate DELs in place prior to submitting the drug submission was imperative and almost a pre-requisite activity.

Revised requirements

Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada is revising the process related to the requirements for evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.

As of the date of this Notice (February 10, 2017), and as detailed below, TPD will also accept submissions where a complete application to amend the DEL pursuant to C.01A.006 of the FDR for new buildings and activities not currently listed on the drug submission sponsor’s DEL has been filed with the Minister at least 90 days prior to the time of filing a drug submission.

This requirement will be applicable to all NDS, EUNDS, ANDS, AEUNDS, Supplements, and DIN applications, thereto, submitted to the TPD for review. Eligible submissions are those where

(1) all required buildings and activities are listed on the current DEL,

(2) a site has a GMP compliance rating in Canada for the required activities and dosage form(s), and/or

(3) a complete DEL application has been filed with the Minister for any new buildings and activities.

Please note this notice is applicable ONLY to the drug submissions to TPD referred in this notice, and these are NOT applicable to drug submissions to the BGTD or any other directorate at Health Canada.

Where a DEL application was needed, the sponsor may file the drug submission 90 days after the Acknowledgment of Application Acceptance for the DEL application is issued by the Minister. Drug submissions which do not meet the requirements listed above will be issued a screening rejection letter.

In addition, where any site listed in a drug submission is considered by Health Canada to be non-compliant for GMP, a screening rejection letter will be issued.

The original complete notice published by Health Canada can be found at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/notice_gmp_el_avis_bpf_le-eng.php

Please refer to the table below that provides a summary of activities that require documentation of a valid DEL and/or DEL application.

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