Notice of clarification to drug manufacturers and sponsors - Risk Management Plans - Update

August 13, 2020

Purpose

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required by Health Canada, such as controlled distribution programs, are not intended to restrict access to Canadian Reference Products (CRPs) for generic drug manufacturers for the purposes of conducting comparative testing. Any RMP elements should not delay or hinder comparative testing with generic products or hinder their ability to enter the market.

Implementation of RMPs in Canada

In February 2009, Health Canada announced the implementation of risk management planning and in June 2015 released the Guidance Document Submission of Risk Management Plans and Follow-up Commitments.

Quick Facts on RMPs

An RMP is a document that outlines pharmacovigilance activities and interventions to identify, characterize, prevent or minimize risks related to drug products. The RMP also contains an evaluation of the effectiveness of such risk minimization measures.

Risk minimization measures in an RMP aim to optimize the safe and effective use of a drug throughout its life cycle (e.g. appropriate labelling). However, for certain drugs with serious risks, more restrictive measures may be required when labelling alone is not enough to ensure the benefits outweigh the risks. For these drugs, Health Canada may require more restrictive risk minimization measures, such as a controlled distribution program. Under such programs, drugs may only be distributed through certain channels, and pharmacies, physicians, and patients may need to register to access the drug.

RMPs and Access to CRPs for Generic Drug Manufacturers

Before a generic drug can enter the market, a generic drug manufacturer must prove that the drug is safe and effective by submitting comparative testing to demonstrate that it is pharmaceutically equivalent to the branded drug. To complete this testing, the manufacturer needs access to samples of the branded drug, also known as the CRP. These studies are then submitted to Health Canada for regulatory approval to market the generic drug.

Manufacturers of branded drugs cannot use elements of an RMP, such as a controlled distribution program, to prevent generic drug manufacturers from conducting comparative testing. A branded manufacturer that provides samples of the branded drug to a generic manufacturer to conduct comparative testing is not violating the RMP.

Moreover, comparative testing by a generic manufacturer falls under the clinical trial regulatory framework. This framework contains ways to protect the safety of clinical trial participants. See Part C, Division 5 of the Guidance Document - Drugs for Clinical Trials Involving Human Subjects.

Health Canada is committed to making sure that RMPs continue to contribute to patient safety. It also reminds sponsors that RMP elements should not be seen as a reason to delay or stop comparative testing with generic products, or to prevent them from entering the market.

For inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate (MHPD)
E-mail: mhpd-dpsc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738