Regulatory Compliance Services

SafetyCall’s SafetyNotes and PV Works documentation systems are designed to facilitate the documentation and management of all Adverse Event Reports. Our health care specialists are trained to obtain all the required case information in preparation for the submission of the report to the appropriate regulatory body where a mandatory reporting requirement exists. We are experts in regulatory requirements and can help companies understand their compliance obligations to the FDA, EPA, or Health Canada.

United States

Environmental Protection Agency

FIFRA 6(a)(2) Regulatory Reporting

Companies with products possessing EPA Registration numbers are subject to mandatory reporting requirements for incidents involving these products pursuant to Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) section 6(a)(2). Additionally, EPA registered products with like formulations sold in other countries require that foreign incidents involving these formulations also be reported to the EPA in compliance with FIFRA section 6(a)(2).

SafetyCall FIFRA 6(a)(2) Surveillance Key Services

  • Completion of a Case Severity Assessment consistent with EPA guidelines on each symptomatic case associated with a pesticide registered with the EPA
  • Monthly single incident reports and quarterly aggregate reports to the client for cases of alleged adverse events involving EPA registered products. Adverse events involving EPA registered products will be documented and coded using EPA guidelines.
  • Delivery of cases regarding a patient death to the client within 5 business days for review and submission to the EPA as a mandatory 15-day single incident report

TSCA Regulatory Reporting – USA & Canada

Under the Toxic Substances Control Act (TSCA) Section 8(c), companies are required to record, retain and in some cases report “allegations of significant adverse reactions” to any chemical substance or mixture that they produce, import, process, or distribute and that is not subject to mandatory surveillance compelled by other regulations such as Federal Insecticide Fungicide and Rodenticide Act (FIFRA) 6(a)(2) or the regulations of other agencies such as the FDA.

Furthermore, under TSCA Section 8(e), any person who manufactures, imports, processes or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment, must inform the EPA of the information unless this risk is already known by the EPA. Such information is commonly referred to as “substantial risk information.”

SafetyCall TSCA 8(c) & 8(e) surveillance services shall consist of the following operations:

  • All adverse incident reports are reviewed on a periodic basis, to ensure complete and accurate documentation consistent with the rules outlined in TSCA section 8(c) – 40 §CFR part 717. SafetyCall applies a severity assessment on symptomatic cases and provides a consistency assessment on those cases having a severity of Minor (with patient seen in the ER), Moderate, Major or Death.
  • SafetyCall will identify and flag potential TSCA 8(c) reportable cases that involve “unexpected (as per the label, MSDS or literature) significant adverse reactions.”
  • Those incidents resulting in substantial injury as defined by a severity assessment of Major or Death will be independently reviewed for TSCA section 8(e) reportability in order to identify chemical substances or mixtures that present a substantial risk of injury to health or the environment and it is determined that the EPA is not already aware of the risk.

Food & Drug Administration

Dietary Supplement and Nonprescription Drug Consumer Protection Act

Manufacturers of dietary supplements and/or over-the-counter (OTC) medications must comply with the FDA’s Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462, 120 Stat. 3469) for adverse events (AEs) regardless of whether a causal relationship has been established between the manufacturer’s product and the adverse event.

SafetyCall Dietary Supplement Adverse Event surveillance services consist of the following operations:

  • Documentation of individual case safety reports (ICSRs) based on the core safety data contained within the FDA Form 3500A
  • Review of each new ICSR (or update of existing ICSRs) by a Senior Clinical Toxicologist/Pharmacist or nurse within 1 business day to determine if the report is classified as a serious outcome in accordance with FDA regulations.
  • Classification of each ICSR report as either ‘non-serious’ or ‘serious.’ ICSRs that are flagged as ‘serious’ will be classified as 15-day alert reports and require that an individual FDA Form 3500A be completed by a SafetyCall pharmacist and forwarded to the client for submission to the FDA.

SafetyCall Nonprescription Drug Adverse Event surveillance services consist of the following operations:

  • Documentation of individual case safety reports (ICSRs) based on the core safety data contained within the FDA Form 3500A
  • Review of each new ICSR (or update of existing ICSRs) by a Senior Clinical Toxicologist/Pharmacist or nurse within 1 business day to determine if the report is classified as a serious outcome in accordance with FDA regulations.
  • Classification of each ICSR report as either ‘non-serious’ or ‘serious.’
  • ICSRs that are flagged as ‘serious’ will be classified as 15-day alert reports and require that an individual FDA Form 3500A be completed by a SafetyCall pharmacist and forwarded to the client for review. Once approved, the ICSR will be submitted electronically to the FDA through the PV Works database.

NDA/ANDAs

Manufacturers of a new drug application (NDA) or an abbreviated new drug application (ANDA) must comply with 21CFR310.80 and 21CFR310.98 for adverse events involving their products.

SafetyCall NDA/ANDA Adverse Event surveillance services consist of the following operations:

  • Documentation of individual adverse event reports based on the core safety data contained within the FDA Form 3500A
  • Review of each new ICSR or update to an existing ICSR by a Senior Clinical Toxicologist/Pharmacist or nurse to determine if the report involved a serious unexpected (unlabeled) adverse effect
  • Classification of reports flagged with serious unexpected AEs as 15-day alert reports, requiring that an individual FDA Form 3500A be completed by a SafetyCall pharmacist. The Form 3500A will be delivered to the Client for review and final sign-off before submission to the FDA via the PV Works database.
  • Reports which have been classified as serious expected (labeled) AEs or non-serious AEs will be classified as periodic reports.  A FDA Form 3500A for each Non-expedited AE report shall be completed and delivered to the client for review prior to the anniversary date of the NDA/ANDA. Following approval, periodic ICSRs will be submitted electronically to the FDA through the PV Works database.

At the client’s request, SafetyCall may assist in the preparation of the PADER.

Medical Devices

Manufacturers of medical devices must comply with the Medical Device Reporting (MDR) regulations (21 CFR 803) for adverse events involving their products.

SafetyCall MDR surveillance services consist of the following operations:

  • Documentation of individual MDR reportable events based on the core safety data contained within the FDA Form 3500A
  • Review of each new MDR report or update made to an existing MDR report by a Senior Clinical Toxicologist/Pharmacist or nurse to determine if the report involved a serious injury or a malfunction that could have resulted in serious injury as defined in 21CFR803. Each MDR report will be classified as either a ‘Serious’ or a ‘Non-serious’ MDR report.
  • Classification of ICSRs as ‘Serious’ will be classified as Expedited 30-day alert reports, requiring that an individual FDA Form 3500A be completed by a SafetyCall pharmacist and forwarded to the client for review.  Once approved, the ICSR will be submitted electronically to the FDA through the PV Works database.

Consumer Product Safety Commission

CPSC Adverse Event Database Service

The Consumer Product Safety Commission (CPSC) Consumer Product Incident Database was established to serve as a government funded forum, where the public can search for consumer allegations of injury or believed risk for injury related to the use of CPSC regulated consumer products or substances. If a consumer reports to the CPSC a product related adverse event that satisfies the minimum required information for publication, the Commission will transmit the report to the manufacturer, or private labeler, within 5 days of receipt by the Commission. Once received, the manufacturer will then have 10 days to provide a written response that will be published along with the consumer report in the database.

SafetyCall Key Service Elements

Establishing an on-going system of surveillance for CPSC incidents which includes:

  • Receiving, documenting and tagging those consumer incidents that are forwarded to your company by the CPSC
  • Identifying “materially inaccurate” incident data and verifying the claim is eligible for publication
  • Provision of a Senior Toxicologist review and drafting of an articulate, professional response for submission consideration by the manufacturer in response to the consumer’s report

Canada

Natural Health Products / Drugs

Manufacturers of drugs and natural health products in Canada must comply with the Food and Drugs Regulations and the Natural Health Products (NHP) Regulations.

SafetyCall NHP/Drug adverse reaction surveillance services for Canada shall consist of the following operations:

  • Documentation of individual adverse reaction (AR) reports based on the core safety data contained within the Health Canada Mandatory Adverse Reaction Reporting Form for Industry for NHPs or the CIOMIS I for drug products.
  • Review of each new AR report or update to an existing AR report by a Sr. Clinical Toxicologist/Pharmacist to determine if the report involved a serious outcome
  • Classification of AR reports that are flagged as ‘serious’ as Expedited 15-day alert reports, requiring that an individual Mandatory Adverse Reaction Reporting Form for Industry be completed for NHPs or a CIOMS I completed for drugs. The appropriate form will be delivered to the client for submission to Health Canada.
  • At the Client’s request, SafetyCall may assist in the preparation of the Annual Summary Report for each licensed NHP or drug.

Pest Management Regulatory Agency

Canada PMRA

Clients with active ingredients and/or pesticides registered with the Canadian Pest Management Regulatory Agency (PMRA) are subject to mandatory reporting requirements pursuant to the Pest Control Products Incident Reporting Regulations. These regulations require the submission of electronic PMRA Incident Reporting Forms within prescribed timelines based on the severity classification of individual Canadian incidents.

Additionally, all formulations sold by a Canadian company’s affiliated or subsidiary company in the USA that contain active ingredients that are registered with the PMRA, must have certain US incidents associated with these active ingredients also reported to PMRA.

Finally, for each active ingredient associated with 10 or more incidents over a prescribed 12 month period, the registrant must provide an annual summary report identifying the total number of incidents reported and providing a concise critical analysis of the data.

SafetyCall PMRA Surveillance Key Services

  • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the PMRA.
  • Electronic submission of incident reports to the PMRA within 15 days, 30 days, 3 months or 12 months, depending on the severity of a given incident as well as the species involved. SafetyCall will complete the appropriate PMRA designated electronic Incident Report Forms for delivery to and review by the client well in advance of the deadline for submission to the PMRA by the Client.
  • At the request of the Client, SafetyCall consulting services may be used to assist in the preparation of the Annual Reports required for each active ingredient associated with 10 or more incidents over the prescribed 12 month period.
  • In addition to the mandatory data fields, the PMRA Incident Reporting Form contains an optional field for the provision of supplemental qualifying information. For those incidents of significance having a severity of moderate, major or death, SafetyCall may also be used to provide a toxicological assessment as to the clinical relevancy of the incident and its biological plausibility.

Canadian Consumer Product Safety Act

Canadian Consumer Product Safety Commission Services

The Canadian Consumer Product Safety Act (CCPSA) is a recently enacted law that applies to a wide variety of consumer products including children’s toys, household products, sporting goods and specialty chemicals. The Act requires industry to provide information to Health Canada concerning consumer product safety incidents or product defects that result, or could reasonably be expected to result, in death or serious harmful health effects. This “early warning” provision also applies to inadequate labeling or instructions that could lead to the same results, and to recall orders or other corrective measures initiated in other jurisdictions for human health or safety reasons. It is important to note that serious incidents occurring outside of Canada may also fall under this new regulation if the consumer product involved is also sold in Canada.

SafetyCall CCPSA Surveillance Key Service Elements

  • Independent review by a Senior Clinical Toxicologist of all adverse events for potential CCPSA reportability
  • Expedited completion of severity/consistency assessments of all symptomatic human cases
  • Immediate delivery of mandatory 2-Day alert reports on the appropriate regulatory forms for client submission to Health Canada
  • Assistance with the preparation of the mandatory 10-day Follow-up report.
SafetyCall’s SafetyNotesTM and PV Works documentation systems are designed to facilitate the documentation and management of all Adverse Event Reports. Our health care specialists are trained to obtain all the required case information in preparation for the submission of the report to the appropriate regulatory body where a mandatory reporting requirement exists. We are experts in regulatory requirements and can help companies understand their compliance obligations to the FDA, EPA, or Health Canada.

EPA – Animals

FIFRA 6(a)(2) Regulatory Reporting

Companies with products possessing EPA Registration numbers are subject to mandatory reporting requirements for incidents involving these products pursuant to Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 6(a)(2). Additionally, EPA registered products with like formulations sold in other countries require that foreign incidents involving these formulations also be reported to the EPA in compliance with FIFRA section 6(a)(2).

SafetyCall FIFRA 6(a)(2) Surveillance Key Services

  • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the EPA.
    SafetyCall will provide single incident and quarterly aggregate reports to the Client for cases of alleged adverse events involving
  • EPA registered products. Adverse events involving EPA registered products will be documented and coded using EPA guidelines
  • Adverse events resulting in death will be delivered to the Client within 5 business days for review and submission to EPA.

TSCA Regulatory Reporting – USA & Canada

Under Toxic Substances Control Act (TSCA) Section 8(c), companies are required to record, retain and in some cases report “allegations of significant adverse reactions” to any substance or mixture that they produce, import, process, or distribute and that is not subject to mandatory surveillance compelled by other regulations such as Federal Insecticide Fungicide and Rodenticide Act (FIFRA) 6(a)(2) or the regulations of other agencies such as the FDA.

EPA’s TSCA Section 8(c) rule requires producers, importers, and certain processors of chemical substances and mixtures to keep records concerning significant adverse reaction allegations and report those records to the EPA upon notice in the Federal Register or upon notice by letter from the EPA. The TSCA Section 8(c) rule also provides a mechanism to identify previously unknown chemical hazards in that it may reveal patterns of adverse effects which otherwise may not be otherwise noticed or detected. An allegation made by an employee must be kept by the company for 30 years by the company while all other allegations (e.g., those made by plant site neighbors or customers) must be kept by the company for 5 years. Further information is available under 40 CFR Part 717.

SafetyCall TSCA 8c surveillance services shall consist of the following operations

  • All adverse incident reports are reviewed on a periodic basis, to insure complete and accurate documentation consistent with the rules outlined in TSCA section 8(c) – 40 §CFR part 717., SafetyCall applies a severity assessment of Minor, Moderate, Major, or death on symptomatic cases, and provides a consistency assessment (marked as Consistent, Inconsistent, or Indeterminable) on those cases having a severity of Minor (with patient seen in the ER), Moderate, Major or Death.
  • SafetyCall will identify and flag potential TSCA 8(c) reportable cases that involve “unexpected (as per the label, MSDS or literature) significant adverse reactions.”

Under TSCA Section 8(e), any person who manufactures, processes or distributes a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to human health or the environment shall immediately inform the EPA of such information unless such person has actual knowledge that the EPA has been adequately informed of such information.

Information does not need to be reported under Section 8(e) if the information:

  • Has been published in the open scientific literature
  • Has been previously reported to the EPA under mandatory reporting
  • Corroborates (in terms of dose, species, route, exposure time, nature of observed effects) information already known to the EPA
  • Standard TSCA 8c surveillance will be completed as described previously
  • Cases that are determined as either Inconsistent or Indeterminable. If a case is marked as consistent, it will then be reviewed by a Senior
  • Clinical Toxicologist to determine if it falls under Section 8(e) reporting requirements. A search in SafetyNotes™ using the Potential TSCA 8e cases report will be conducted monthly to find these cases.
  • If a case may be reportable under 8(e), the case will be tagged in the SafetyCall Client database as Potentially 8(e) reportable
  • The SafetyCall Client Liaison will notify the Client that the case has been classified as Potentially 8(e) reportable and will forward them a copy of the case detail report.

FDA Center for Veterinary Medicine

FDA Regulatory Reporting

In addition to the adverse event management for veterinary pharmaceutical products, SafetyCall International can assist animal drug manufacturers/marketing authorization holders (MAH) remain compliant with FDA regulations via our veterinary adverse event reporting services.

Under section 21 CFR 514.80(b) of the FDA’s regulations, applicants of approved new animal drug applications (NADAs) and approved abbreviated new animal drug applications (ANADAs) are required to report adverse drugs events and product and manufacturing defects in a timely manner. This continuous monitoring is the primary means by which FDA’s Center for Veterinary Medicine (CVM) obtains information regarding potential problems with the safety and efficacy of marketed approved new animal drugs as well as potential product/manufacturing problems.

SafetyCall’s team of experienced veterinary professionals operates our veterinary adverse event service and can help to ensure FDA compliance by:

  • Identifying and tracking all cases in need of mandatory reporting (3-day, 15-day, periodic)
  • Establishing due diligence by providing timely and thorough case follow with all necessary reporters (pet owners, veterinarians, etc.)
  • Completing reports via the Safety Reporting Portal or revised Form 1932 in a timely and medically professional manner. Once the reports are complete, the MAH will be notified so that they may then review and submit the reports.
  • Providing clinical expertise to assist the MAH in determining causality assessments.
  • Periodic Drug Experience Reports (PDER) can also be completed at the client’s request.

 

USDA APHIS

The United States Department of Agriculture, Animal and Plant Health Inspection Service (USDA APHIS) regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective.

SafetyCall International does not offer any USDA reporting services for animal products. We do, however, manage any adverse events related to vaccines.

PMRA – Animals

Canada PMRA

Clients with active ingredients and/or pesticides registered with the Canadian Pest Management Regulatory Agency (PMRA) are subject to mandatory reporting requirements pursuant to the Pest Control Products Incident Reporting Regulations. These regulations require the submission of electronic PMRA Incident Reporting Forms within prescribed timelines based on the severity classification of individual Canadian incidents.

Additionally, all formulations sold by a Canadian company’s affiliated or subsidiary company in the USA that contain active ingredients that are registered with the PMRA must have certain US incidents associated with these active ingredients also reported to the PMRA.

Finally, for each active ingredient associated with 10 or more incidents over a prescribed 12 month period, the registrant must provide an annual summary report identifying the total number of incidents reported and providing a concise critical analysis of the data.

SafetyCall PMRA Surveillance Key Services

  • Completion of a Case Severity Assessment on each symptomatic case associated with a pesticide registered with the PMRA.
  • Incident reports must be electronically submitted to the PMRA with 15 days, 30 days, 3 months or 12 months depending on the severity of a given incident as well as the species involved. SafetyCall will complete the appropriate PMRA designated electronic Incident Report Forms for delivery and review by the Client well in advance of the deadline for submission to the PMRA by the Client.
  • At the request of the Client, SafetyCall consulting services may be used to assist in the preparation of the Annual Reports required for each active ingredient associated with 10 or more incidents over the prescribed 12 month period.
  • In addition to the mandatory data fields, PMRA Incident Reporting Form contains an optional field for the provision of supplemental qualifying information. For those incidents of significance having a severity of moderate, major or death, SafetyCall may also be used to provide a toxicological assessment as to the clinical relevancy of the incident and its biological plausibility.