Vol. 148, No. 12 — June 4, 2014
SOR/2014-125 May 16, 2014
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (Retention of Records — Miscellaneous Program)
P.C. 2014-581 May 15, 2014
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), makes the annexed Regulations Amending the Food and Drug Regulations (Retention of Records — Miscellaneous Program).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (RETENTION OF RECORDS — MISCELLANEOUS PROGRAM)
1. Paragraphs C.07.010(a) and (b) of the Food and Drug Regulations (see footnote 1) are replaced by the following:
- (a) establish and maintain records, in a manner that enables an audit to be made, respecting the information referred to in subsection C.08.007(1), and retain those records for at least seven years from the day on which they were established; and
- (b) provide to the Minister the summaries referred to in section C.08.008.
2. Section C.08.007 of the Regulations is amended by adding the following after subsection (1):
(1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established.
3. Paragraphs C.08.008(a) to (c) of the Regulations are replaced by the following:
- (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary;
- (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately on the manufacturer establishing the record; and
- (c) a summary of a record respecting any information referred to in paragraph C.08.007(g) or (h), within 15 days of the day on which the manufacturer established the record.
COMING INTO FORCE
4. These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
The Standing Joint Committee for the Scrutiny of Regulations (SJCSR) identified that the lack of clarity regarding the record retention period described in paragraph C.07.010(a) and subsection C.08.007(1) of the Food and Drug Regulations (the Regulations) may cause undue burden on manufacturers who end up keeping records for longer than necessary.
Currently, the Regulations include a list of information that manufacturers must collect and maintain for inspection and auditing purposes, but there is no timeframe specified for this record-keeping requirement. Information gathered through a small, informal survey of drug manufacturers supports the need for clarification. Of the five companies that responded to the survey, one company indicated that they maintain the records in question for as long as required under the Good Manufacturing Practices (GMP) provisions of the Regulations (i.e. for one year after the labelled expiry date of the batch of drug product, ranging from three to seven years). Four other companies stated that they currently keep the records in question for an indefinite period of time.
This regulatory amendment will address the issue identified by the SJCSR by providing clarity regarding record retention requirements for manufacturers of new drugs.
The list in subsection C.08.007(1) of the Regulations details the information that manufacturers must compile and maintain for inspection and auditing purposes. The information falls into the following categories: records regarding clinical trials and animal testing; results of developmental chemistry investigations and stability testing; manufacturing records and batch analysis; reports of adverse drug reactions; and published scientific literature. Currently, the Regulations are silent as to how long these records must be kept.
The amendment sets a requirement for all manufacturers of new drugs to keep this information for at least seven years from the date the records were established. The seven-year period was derived by calculating the maximum cumulative record retention period that could be applied to these drugs. For example, if an active pharmaceutical ingredient with a retest period of three years were to be used in the manufacture of a drug towards the end of its retest period, and that drug product had an approved expiry period of three years, then records will have to be kept for the combined six years plus one extra, as required by section C.02.021 of the Regulations.
It is important to note that other provisions in the Regulations may place further record keeping requirements on the manufacturer, but seven years is the minimum.
The list in subsection C.08.007(1) is referred to in the Canadian Access to Medicines Regime (CAMR) in paragraph C.07.010(a). Consequently, in response to the issue raised by the SJCSR, a seven-year record retention period is also being implemented for the CAMR regulatory framework.
Some non-substantive changes have also been included to correct errors that were inadvertently introduced when previous amendments were made to the Food and Drug Regulations. These changes are intended to further clarify the interpretation of the Regulations.
The “One-for-One” Rule does not apply to this regulatory amendment, as there is no change in administrative costs to business.
Small business lens
The small business lens does not apply to this regulatory amendment as it does not impose costs on small business.
A short questionnaire about record-keeping practices was distributed to industry stakeholders in the fall of 2012. Five responses were received, and feedback from stakeholders, although limited, supports the proposed regulatory amendment.
In early 2013, three industry associations — whose combined membership represents a large majority of the total number of Canadian drug companies — were consulted. Confirmation was received that the majority of stakeholders currently maintain the records in question for longer than the seven-year period. All three associations stated that the changes brought in by this amendment would be cost-neutral. None raised any objections to the new rule.
These Regulations are intended to provide clarity with respect to record-keeping requirements. Additional amendments have also been included to correct non-substantive errors in the Regulations.
Manufacturers of new drugs are the only stakeholders that will be affected by this regulatory amendment. The seven-year record retention period was derived from internationally aligned GMP-based record retention periods that require manufacturers to keep batch records for at least one year past the expiry date of that batch of drugs. The United States, Europe and Canada have aligned their requirements around GMP record keeping, so companies will not perceive this amendment as adding burden. This has been confirmed through stakeholder feedback following outreach to industry associations.
Implementation, enforcement and service standards
No changes will be required to implement or enforce the proposed regulatory amendment.
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