The safety of prescription drug products is monitored by regulatory agencies both pre- and post-market. US and Canadian pharmacovigilance practice guidelines describe not only the mandatory reporting requirements for serious adverse events reported domestically, globally and in the scientific literature global surveillance, but also the requirements for the preparation of periodic adverse drug experience reports containing a critical analysis of all adverse drug events occurring quarterly or annually, depending on the age of an approved drug.
The health care professionals at SafetyCall have over 30 years of experience responding to issues related to pharmaceutical products. All adverse events are reported, documented and stored in SafetyNotes, our proprietary case management software application. Clients have access to their incident data 24/7 utilizing SafetySearch, a secured password protected web-based search engine.
|Regulatory Agencies||Applicable Federal Laws|
|US Food and Drug Administration (FDA)||Food, Drug and Cosmetic Act 21 CFR 310.305
Food, Drug and Cosmetic Act 21 CFR 314.80
|Health Canada Marketed Health Products Directorate (MHPD)||Food and Drug Act|
Highlights – Rules & Regulations
Several important regulations applicable to the Pharmaceutical Industry are highlighted below:
- Section 3 – Adverse events meeting the FDA defined criteria for serious must be reported to the FDA within 15-days using the FDA Form 3500A and its accompanying data elements.
- Causality is not a prerequisite for tracking and reporting adverse events involving prescription drugs distributed in the USA.
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Your Industry Obligations
Pharmaceutical registrants must also consider the following compliance obligations:
- 21 CFR 310.305 and 21 CFR 314.80
Guidance Documents Forms FDA-Guidance-for-OTC-Drugs.pdf
- Food and Drug Act
Guidance Documents Forms Read more at hc-sc.gc.ca Blank-CIOMS-I-template.pdf