Summary:

The Government of Canada introduced amendments to the Food and Drug Regulations (the "Regulations") and the Patented Medicines (Notice of Compliance) Regulations which provide an application process for the market authorization and protection of Extraordinary Use New Drugs ("EUNDs"). These amendments took effect on March 25, 2011.

Background

EUNDs are used to treat, mitigate or prevent a life threatening or serious health conditions in humans which result from exposure to a chemical, biological, radiological or nuclear substance ("CBRN Substances") in an emergency situation such a pandemic or a terrorist attack.[1]

Under the Regulations, manufacturers are required to demonstrate the safety and efficacy of a "new drug" in order to receive market authorization in Canada. However, in most instances, the safety and efficacy of an EUND cannot be studied in human clinical trials prior to filing a drug submission due to time pressures and ethical concerns. This lack of clinical evidence has typically prevented manufacturers from meeting the requirements needed for market authorization as a "new drug". Hence, the sale of EUNDs was typically authorized under Health Canada's Special Access Programme ("SAP").

The Amendments

The Government of Canada has determined that the SAP is not an appropriate mechanism to regulate the sale of EUNDs for use in pandemics or other emergencies. The amendments establish a new type of drug submission for these products.

Under the new Regulations, a drug manufacturer may file a EUND submission if the new drug is intended for: (a) emergency use in situations where persons have been exposed to a CBRN Substance and action is needed to treat, mitigate or prevent a life-threatening or other serious disease, disorder or abnormal physical state; or (b) preventative use in those persons who are at risk of exposure to a CBRN Substance that is potentially lethal or permanently disabling.

The EUND manufacturer must also demonstrate that the safety of the new drug cannot be established because: (a) exposing human volunteers to the CBRN Substance would be potentially lethal or permanently disabling; and (b) the circumstances in which exposure to the CBRN Substance occur on a sporadic or infrequent basis.

If a drug substance is classified as an EUND, the manufacturer may file a submission that is supported by: (a) certifications from the manufacturer's senior executive officer and senior scientific officer stating that the drug meets the EUND criteria; (b) data from in vitro or animal studies; (c) the drug's mechanism of action (d) draft labels; and (e) detailed plans for post-market safety and efficacy studies etc.

EUND submissions must meet all other requirements for new drug submissions (e.g., serious adverse reaction reporting, good manufacturing practices, data and patent protection). Since EUNDs are intended as countermeasures against pandemics and terrorist attacks, these products can only be sold to federal, provincial, territorial and municipal governments. Generic drug manufacturers are permitted to submit abbreviated EUND submissions for products that meet the EUND criteria. The PM(NOC) Regulations and Data Protection Regulations have been amended to account for new EUND and abbreviated EUND submissions.

Health Canada plans to provide a guidance document for manufacturers in late 2011.

LINKS TO CANADA GAZETTE:

Regulations Amending the Food and Drug Regulations

Regulations Amending the PM(NOC) Regulations