OTC Drug Regulatory Compliance Solutions

Royal Canada provides Health Canada’s OTC Drug Regulatory Compliance Solutions

A spectrum of drug classifications exists, spanning over-the-counter (OTC) products, prescription medications, radiopharmaceuticals, biologics, and gene therapies. OTC Pharmaceuticals, often termed non-prescription drugs, constitute health commodities available in the Canadian market without requiring a medical prescription. Ensuring their safety and efficacy involves presenting supporting evidence, either through pre-established data from OTC drug monographs or from clinical trials conducted on innovative treatments. The supervision of OTC medications falls within the purview of Health Canada, aimed at safeguarding their safety and minimizing potential health risks for the Canadian populace.

Monograph Classifications:

Various categories apply to monographs for Over-the-Counter (OTC) Drugs in Canada. These encompass Labeling Standard, TPD Category IV, and Non-steroidal Anti-Inflammatory Drugs (NSAIDs).

Ensuring Quality Manufacturing:

All enterprises, whether domestic or international, engaged in the production, distribution, or import of OTC pharmaceuticals, must furnish evidence of their compliance with Good Manufacturing Practices (GMP).

Business Authorization:

An obligatory prerequisite for engaging in the fabrication (manufacturing), packaging, labeling, testing, importing, distributing, or wholesaling of finished drugs or bulk process intermediate drugs.