Health Canada Proposes to Update Regulations for Biologic Drugs

Health Canada Proposes to Update Regulations for Biologic Drugs

February 17, 2023 By

On December 16, 2022, Health Canada issued a notice to stakeholders regarding their proposal to amend the regulations for Biologic Drugs (Schedule D drugs) in Division 4, Part C, of the Food and Drug Regulations.

This notice is intended for companies that fabricate, package/label, test, store, import, distribute, and/or wholesale biologic drugs.

The Purpose of this Proposal is to:

  1. Support practices that currently address biologic drugs, and;
  2. Better address advancements in science and technology.


This applies to drugs listed on Schedule D of the Food and Drugs Act (FDA)

  • Division 4 in Part C of the Food and Drugs Regulations that are specific to biologic drugs
  • Schedule D in the FDA sets out legislation for biologic drugs to which Division 4 applies

What are the changes?

The amendments to Division 4 propose to:

  • Replace existing Division 4 regulations (from C.04.001-C.04.683 to C.04.001-C.04.010)
  • Add a new regulation to Division 2 (C.02.012.1)
  • Amend a regulation in Division 8 (C.08.003.1)

For your convenience, here is an outline of the proposed amendments to the regulations:

Prohibitions on sale

New regulations C.04.002 & C.04.003 replaces the current C.04.001.1

  • C.04.002 prohibits the sale of biologic drugs and their active ingredients by importers or distributors unless they comply with the provisions of Division 4.
  • C.04.003 prohibits the sale of biologic drugs and their active ingredients that are fabricated, labelled, or tested in Canada by any person, which includes parties other than the DIN holder, unless they comply with the provisions of Division 4.

Biological source material

New regulation C.04.004 replaces C.04.050-C.04.683 and incorporates concepts from C.04.016-C.04.018

  • Ensures that biological source materials are suitable for use in the fabrication of the drug.
  • Collected under medical (or veterinary) supervision, with record keeping to trace the material.
  • The proposed regulations clarify the record retention expectation for DIN holders – which cannot be less than 5 years.

Prevention of contamination

New regulation C.04.005(1) and (2) is based on C.04.013-C.04.014, and maintains the intent behind (and replaces) C.04.050-C.04.683
The proposed amendments include:

  • A general framework to minimize the potential for contamination. The proposed C.04.005(1) adds to the current C.04.013.

Reference preparations

New regulation C.04.006 maintains the original intent and replaces current C.04.050-C.04.683
The proposed amendments include

  • Clearly outlining the expectation that the reference preparations be appropriate for their intended function.
  • A DIN holder should not need to file information for existing products other than for reportable changes that are identified in post-Notice of Compliance (NOC) quality changes guidance.

Lot release

New regulation C.04.007 are equivalent to current C.04.015 and replaces C.04.50-C.04.683
The proposed amendments include:

  • C.04.007(1) providing authority to Minister to ask for information, samples of drugs or material to be used to test the samples (Lot Release Activities). C.04.007(2) sets out that a DIN holder cannot sell a drug that has been requested by the Minister.
  • Continuing to provide flexibility by allowing for the movement of biologic drugs between evaluation groups on a case-by-case basis, with each group having differing levels of regulatory oversight, based on the degree of risk associated with the drug (tiered approach).

Periodic quality reporting

New regulation C.04.008 will allow for increased flexibility for the Minister to perform periodic quality reporting at their discretion, no longer making Yearly Biologics Product Reports mandatory for all biologic drugs at all times.

Labelling, labelling exemption, labelling of prescription drugs

New regulations include C.04.009 and C.04.010 and are equivalent to the current C.04.019 and C.04.020 and replace C.04.050 to C.04.683.

New regulations should not require changes to labelling of biologics currently on the Canadian market.
The proposed amendments include:

  • Introducing flexibilities into Division 4 for small containers, outlined in Division 1 of C.04.009(6) to make provisions for biologic drugs
  • Providing additional transparency to the user including:
    • Indication of human or animal source
    • Safety statements
    • Storage statements including templates for cycle storage claims
    • An exemption for the expiry date on the label for stockpile drugs
      • Normally used when drugs are stockpiled during emergency situations
      • Allowed so long as alternate means to communicate the expiry date to the end user exists
  • Health Canada using their discretion to require biologic drugs to contain certain statements for safety reasons for circumstances such as:
    • Indication of dosage forms intended solely for pediatric or adult use
    • For multi-dose vials indication where administration of entire content could cause injury
    • Drugs that require dilution
    • Differentiation between diluents and active components of a kit


New regulation C.02.021.1 maintains storage provisions within (and also replaces) C.04.050 to C.04.683.

The proposed amendment would make it clear that the drugs should be prepared, stored, and transported in a way that preserves their quality.

On-site evaluations

New regulation C.08.003.1

The proposed amendments include:

  • Giving the Minister authority to examine drug material on a risk-based, case-by-case basis during Health Canada’s review of a drug submission.
  • Giving greater transparency around potentially considering information obtained from on-site evaluations (OSEs) and from foreign regulatory partners during the review of drug submissions.
  • Giving greater transparency around potentially considering information obtained directly or indirectly from manufacturing sites during the market authorization of biologic drugs.

Expiry date

The proposed regulations for expiry date will rely on current (C.01.001(1), C.02.027, C.02.028, C.08.002(2)(f) and C.08.002(2)(g)) to maintain (and replace) provisions set out in the current C.04.050-C.04.683

Corresponding regulations

The proposed amendments include:

  • Repealing C.04.002, which sets out that Division 4 doesn’t apply to a drug that contains micro-organisms if the drug is recommended for restoring, normalizing, or stabilizing intestinal flora because such products are covered by the Natural Health Products Regulations (NHPR).
  • Repealing “date of issue” requirements within C.04.003 because the temperature ranges wherein are incorrect. This provision would no longer be needed because product-specific regulations in Division 4 for “date of issue” are proposed to be replaced.

Consequential amendments

The proposed amendments include:

  • Part A:
    • A.01.048(d): proposed amendment would update references to the new Division 4 numbering
  • Part C:
    • Division 1, C.01.004(5) (labelling):
      • The proposed amendment for Schedule D drugs to be excluded from some Division 1 labelling.
      • The exclusion, which is currently in Division 4 (C.04.019), is proposed to be in Division 1 (C.01.004(5)(c )).
    • Division 2:
      • The proposed amendment would replace the “Quality Control Department” heading with “Quality Control”.
      • C.02.019(4.1) (finished product testing): the proposed amendment to update the reference to the new Division 4 numbering.
    • Division 3:
      • C.03.206 exclusion of Schedule C drugs from Division 4 labelling: update the reference to the proposed new Division 4 numbering.
    • Division 8:
      • C.08.009.04 is about COVID-19 drugs: update the Division 2 numbering that is relevant for the purpose of Division 4 drugs.
      • C.08.011.2(2) is about Special Access Program (SAP) release drugs: update the Division 2 numbering that is relevant for the purpose of Division 4 drugs.
    • Division 10:
      • C.10.001(5) drugs for urgent public health need: update the Division 2 numbering that is relevant for the purpose of Division 4 drugs.
      • C.10.002(2) drugs for urgent public health need: update to the Division 2 numbering.

Who Can Participate?

Anyone. This consultation is open to academics, consumer and patient safety organizations, drug and medical device industry, health system partners, and the general public.

How to Participate?

Submission of comments can be done by downloading this fillable PDF form and sending it to

For your convenience, you can access the notice here

Consultation is closing on March 27, 2023

If you have any questions or concerns about this consultation and how it can impact you or your business, please contact us.