A quick look back
In 2016, Health Canada announced its intention to adopt a structured format for its drug product information. With this structured format, Health Canada aims to increase transparency and accessibility of pertinent data. The move would affect product monograph preparation, electronic submission, and approval processes for human prescription drugs. The transition does not have any impact on human OTC drugs, veterinary drugs, natural health products, and medical food and devices.
What is a product monograph?
Product monographs are scientific documents entirely based on scientific medical and clinical facts including drug properties, claims, and indications of the drugs, as well as any other required information. A product monograph contains three sections, the health professional information, the scientific information, and the consumer information, with the consumer information being similar to information a pharmacist would provide. Because product monographs do not include any promotional materials, they are frequently used in better understanding the value, safety information, and potential adverse side-effects of a drug, and can ultimately aid the prescription and treatment process.
In harmonization with international data standards, Health Canada selected the HL7 Structured Product Labeling (SPL) standard for its product monograph submissions. The program initially named Structured Product Monograph (SPM), fell under the agency’s Health Products and Food Branch (HPFB), which is the department responsible for regulating and ensuring the safety of drug products.
Over the next four years, HPFB authored SPM documentation, developed infrastructure, and performed testing in collaboration with an industry focus group, which Reed Tech joined in partnership with two large international drug product manufacturers.
Health Canada is now confirming its readiness to launch the transition from unstructured product monograph to XML Product Monograph (PM) format. It will start to accept drug information in XML PM 2016 format on a “by request” basis April 1 to July 31, 2020. Beginning June 14, 2021, Health Canada began Phase II: Full Production on a voluntary basis. Health Canada will now check all XML PMs against a defined set of rules to confirm validity of the required data provided.
Why the change to XML PM?
Under the existing system, drug product monographs are submitted in unstructured formats (e.g., MS Word, PDF). To publish this information to its public Drug and Health Product Register, HPFB must convert the content of each monograph manually into XHTML. This process is labor-intensive and cannot deliver many of the benefits of a structured and standardized format such as SPL.
A structured format allows for automatic validation and publishing. It can leverage a controlled vocabulary to standardize terminology and data becomes much easier to search and analyze. It also brings Canada in line with other countries by leveraging an international document standard (SPL or Structured Product Labeling). By adopting the SPL standard, Health Canada has also provided speed and simplicity for technology providers to adapt their existing solutions for the Health Canada XML PM implementation, rather than starting from scratch. This change means that companies distributing drug products in Canada will be able to meet this mandate much more efficiently and smoothly by selecting a technology partner, such as Reed Tech, with established expertise in the SPL realm.
Health Canada is also looking at this initiative to more efficiently distribute drug products, which will make it easier for patients and prescribers to interpret. This will ultimately improve the patient treatment experience.
Similarities and differences to the FDA SPL Program
Scope – FDA’s adoption of SPL began in 2005 with only human prescription drugs and has expanded to 60+ submission types. Health Canada is taking a similar first step, applying XML PM to only human prescription drugs. This scope currently does not include human over-the-counter and animal health products.
Controlled Vocabularies – There are approximately 30 Health Canada controlled vocabulary lists. While there is some overlap with FDA lists, they are mostly unique. The eventual target is to align these terminologies with international standards, (e.g., ISO Identification of Medicinal Products, also known as IDMP).
Implementation Guide and Stylesheet – Health Canada has published its own version of implementation guides and developed its own stylesheet to render regularly readable presentations of XML PM content.
Language – The Health Canada XML PM content will be required in both English and French.
Health Canada Timeline
More details on timing and procedures can be found in the January 13, 2020 launch notice from Health Canada.
How we can help
All of these changes will need to be updated within drug labeling systems. While this transition to a more structured product monograph system may seem daunting, Reed Tech has the experience and expertise to help you. Reed Tech has been participating in the pilot activities with Health Canada and key pharma manufacturers since the initial kick-off in 2017, attending meetings and providing our expertise in SPL to help clinically test, evaluate, and improve on the new Health Canada XML PM draft guidance, stylesheets, and schema versions.
We have provided Structured Product Labeling (SPL) services for U.S. FDA drug labeling to more than 1,000 pharmaceutical companies since 2005 and can support the conversions of product monographs to the XML PM format as required by Health Canada.
Let us help you through this new transition by contacting us at [email protected], or give us a call at 215-557-3010 to talk to one of our XML specialists. We can answer your questions and walk you through the process.