On May 11, 2019, draft regulations amending the special access provisions in Division 8 of the Food and Drug Regulations (FDR) were published in the Canada Gazette Part I. At the same time, Health Canada released a Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs.
The draft regulations and guidance outline a significant change in the operation of the Special Access Program for Drugs (SAP) with the introduction of "pre-positioning" unauthorized drugs in Canada. In effect, these changes will allow unauthorized foreign drugs to be imported into Canada to be held in inventory in anticipation of letters of authorization being issued by Health Canada permitting the distribution of the drug.
According to the draft regulations and guidance, Health Canada may issue an authorization to a drug manufacturer permitting the importation of a quantity of unauthorized foreign drug by the holder of a Drug Establishment License (DEL) where the following conditions are met:
1) the drug manufacturer supplies the following information to Health Canada:
- the name of the drug and details concerning the medical emergency for which the drug will be imported;
- the quantity of the drug to be imported;
- the name of the holder of a DEL who will import the drug;
- the civic address of the facility where the drug is to be stored in Canada, and
- any additional information that Health Canada may request in respect of the medical emergency or the safety and efficacy of the drug in relation to the medical emergency.
2) the importer's DEL authorizes the importation of a drug in the same category as the one to be imported; and
3) the quantity that is to be imported does not exceed the amount that Health Canada determines is likely to be required to address the medical emergency.
In connection with the authorization, Health Canada may also request that the manufacturer provide a copy of any report that was submitted, for the purpose of evaluating the safety, efficacy and quality of the drug, to a foreign regulatory authority that has authorized the sale of the drug in its jurisdiction.
For its part, the importer will be required to comply with certain GMP requirements in Division 2 of the FDR (relating primarily to storage, recall, record keeping and transportation), but notably, will not be required to have related foreign buildings listed in the foreign building annex or active pharmaceutical ingredient annex to its DEL.
After the drug has been "pre-positioned" in Canada pursuant to an authorization from Health Canada as above, the importer may distribute the foreign drug to practitioners pursuant to a letter of authorization issued by Health Canada according to the current established SAP protocol.
According to the regulatory impact analysis published with the draft regulations, the primary purpose of this new "pre-positioning" SAP framework is to create a more efficient process for access to unauthorized drugs in emergency, serious or life threatening situations, including shorter shipping time of drugs to practitioners.
The proposed new regulations will come into force on the day that they are registered, which is likely to occur at some time following the expiry of the 70-day open comment period.