SPharm: Regulatory Leader in Responding to the COVID-19 Crisis

THE COVID-19 PANDEMIC HAS BROUGHT UNPRECEDENTED SCIENTIFIC, REGULATORY AND product development coordination challenges worldwide, impacting almost every aspect of daily life, both professionally and personally. All branches of Healthcare as well as Life Sciences industry leaders have been at the forefront of the fight against this global health crisis, utilizing their expertise and resources to combat the virus and support those affected by it.

A leading regulatory intelligence and services firm in Canada that specializes in rare diseases and orphan drugs, SPharm Inc., turned its attention to how their own efforts could contribute to stopping COVID-19 from spreading and treat those who have contracted it. With their unique position in the market, SPharm facilitated the development of various drugs including vaccines, medical devices and other health products aimed at responding to the COVID-19 crisis. Thus far, the company has been able to contribute to the development of close to 50 COVID-19 related health products, through development strategies, clinical trials regulatory support in Canada and the USA, and various market & license applications, with some of them reaching the market in record time.

Streamlined Approval Processes

“It was important to us that we develop internal procedures that ensured product development and regulatory processes be as frictionless as possible to ensure an expeditious response to clinical trials and market & license applications needs, while at the same time offering regulatory strategies that facilitated the global regulatory process,” shares Susanne Picard, founder and CEO of SPharm Inc. “By doing so, we were able to support sponsors prioritizing COVID-19 products, and, in our own way, lessen the spread of the virus and help people recover.”

These products include 10 drugs/vaccines/biologics, 26 hand sanitizers and disinfectants, and 12 medical devices. All vaccines were novel and of various types (including recombinant & peptide-based) for the prevention of SARS-CoV-2 infection and COVID-19 disease. The drugs were either novel or known for treatments in other indications to treat mild to severe COVID-19 disease. Medical devices include oxygen concentrators / distributors, various diagnostic tests, protective masks & gloves.

Significance Of Accelerated Timelines

To understand the significance of the accelerated timelines achieved, it is important to consider the typical development and submission timelines of such products. Health Canada’s clinical trial review timeline was reduced from 30 days to 14 days under an interim order. Drug submission review timelines were shortened from the regular NDS scientific review time of 300 days to shorter review timelines for Priority Reviews (180 days) or Notice of Compliance with condition (200 days) during the pandemic. These faster review timelines are granted for drugs that offer a significant improvement in the treatment of a serious or life-threatening condition, or for drugs that address an unmet medical need; COVID-19 related products fall into this category. Furthermore, many interim orders were introduced by Health Canada to facilitate the market access of Medical Devices and other health products.

Navigating Health Canada Regulations

Bringing novel drugs, medical devices, and other health products to market requires knowledge and dedication; COVID-19 related products, in particular, require an experienced and knowledgeable team to navigate Health Canada’s expedited requirements. The industry’s leaders had to navigate the new Health Canada rules and regulations to get these critical health products on the market in record time. SPharm’s contribution to the COVID-19 response efforts highlights the importance of regulatory intelligence providers in navigating the everchanging regulatory landscape.

As the world continues to battle the COVID-19 pandemic, and potentially future events, companies like SPharm play a crucial role in supporting the industry’s efforts to improve the well-being of citizens. The pandemic demonstrated that the healthcare industry needs leaders who are dedicated to innovation and collaboration, and who can adapt quickly to rapidly changing regulatory landscapes. SPharm’s response to the COVID-19 crisis serves as a testament to the invaluable achievements made possible when an entire industry works towards a common goal of improving the safety and wellness of its citizens.

About Spharm

SPharm is an award-winning company with a 99% submission approval rate in a broad range of therapeutic areas. They are a trusted partner to efficiently manage challenging submissions of groundbreaking health products for various diseases including, rare and ultra-rare diseases. SPharm has high standard security measures and a sterling reputation as Canadian regulatory experts, they are recognized as a well-established firm with deep relationships in the health product regulatory sector. Learn more at spharm-inc.com