Drug access delays due to pharmaceutical companies not Health Canada

May 12, 2014

Access to new prescription drugs in Canada is delayed by pharmaceutical company submissions to Health Canada rather than by a longer approval-processing time, according to an analysis published in CMAJ (Canadian Medical Association Journal).

The submission of new drugs to Health Canada is substantially delayed compared with submissions in the United States and the European Union.

"New drugs reached the market much later in Canada than in the US and the EU because of long delays before their submission to Health Canada," write Ali Shajarizadeh and Aidan Hollis, Department of Economics, University of Calgary, Calgary, Alberta. "For drugs that were ultimately approved in Canada and in at least one of the other jurisdictions, the mean delay from first submission in either foreign jurisdiction to submission in Canada was 540 days."

The authors determined that the capacity of pharmaceutical companies to navigate the regulatory process in less-profitable countries such as Canada -- smaller companies may lack resources and expertise -- and the desire to obtain approval of first-in-class drugs with higher potential sales are the main reasons for timing of submissions.

"We found that corporate capacity and priority status of new drugs are important determinants of submission delays," write the authors.

"We believe that the harmonization of the regulatory processes of the FDA and Health Canada may accelerate drug submissions in Canada," conclude the authors, although they note that the situation can vary for each drug.
-end-


Canadian Medical Association Journal

Related Prescription Drugs Articles from Brightsurf:

One quarter of prescription drugs in Canada may be in short supply
Research from the Centre for Health Evaluation and Outcome Sciences (CH√ČOS) sheds new light on the factors behind drug shortages in Canada, a common problem across the country.

Prescription opioid use, misuse among cancer survivors
This survey study looked at the frequency of prescription opioid use and misuse among adult cancer survivors compared with individuals without cancer.

Medicare Part D favors generic prescription drugs over branded counterparts, study finds
Published this week in Health Affairs, the study led by Stacie Dusetzina, PhD, Ingram Associate Professor of Cancer Research and associate professor of Health Policy, compared Medicare Part D coverage of more than 1,360 pairs of generic and brand-name drugs.

Regular use of prescription drugs for pain and sleep increases frailty risk by 95 percent
Regular use of prescription drugs for pain and sleep increases frailty risk by 95 percent among older adults.

ACP issues policy recommendations aimed at mitigating the rising costs of prescription drugs
In two new policy papers, the American College of Physicians (ACP) calls for changes aimed at mitigating the rising cost of prescription drugs.

Codeine misuse in Australia reduced by prescription-only changes
The move to prescription-only codeine in Australia has seen a 50 percent reduction in the monthly rate of codeine-related poisoning calls and halved codeine sales, finds new research led by the University of Sydney.

Nearly 1 in 3 patients with lupus use prescription opioids for pain
A new study finds nearly one in three adults with lupus use prescription opioids to manage pain, despite a lack of evidence that opioids are effective for reducing pain from rheumatic diseases.

Negotiation: A three-step solution to affordable prescription drugs
Criteria are offered by Harvard University and George Mason University experts for Medicare to negotiate drug prices and prioritize specific drugs for maximum savings.

Prescription drug monitoring program mandates
States that require prescribers to register with and use prescription drug monitoring programs in most clinical circumstances saw notably fewer opioid prescriptions and reduced opioid-related hospital use by Medicaid patients compared to states with weak or no drug monitoring program mandates, according to a new study from investigators at Weill Cornell Medicine.

One-third of pre-approved prescription drugs have not completed the FDA approval process
The Food and Drug Administration's (FDA) Accelerated Approval Program was created in 1992 to significantly accelerate the ability to bring certain new drugs to market.

Read More: Prescription Drugs News and Prescription Drugs Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.