1. Drug and Biologic Manufacturers

The FDA’s pharmacovigilance regulations for drugs and biologics fall under 21 CFR Part 314.80 (for drugs) and 21 CFR Part 600.80 (for biologics). These rules require manufacturers to report adverse events, maintain records, and conduct post-marketing surveillance to monitor the safety of their products after approval.

• Key Pharmacovigilance Responsibilities:
  • Adverse event reporting (serious and unexpected)
  • Periodic safety reports (annual and quarterly reports)
  • Risk management plans (for high-risk drugs)
  • Post-marketing studies (if required by the FDA)

Who falls under this regulation?

• Companies holding a New Drug Application (NDA) or Biologics License Application (BLA)
• Generic drug manufacturers (covered under 21 CFR Part 314.98 for abbreviated NDAs)

2. Medical Device Manufacturers

Medical device companies are subject to FDA reporting requirements under 21 CFR Part 803, also known as the Medical Device Reporting (MDR) regulation. This covers adverse event reporting for devices.

Who falls under this regulation?

• Any company that manufactures, imports, or distributes medical devices in the U.S. must comply with MDR regulations. This includes implantable devices, life-supporting, or life-sustaining devices.

3. Combination Products

Products combining drugs, devices, or biologics fall under the Combination Products regulation, which is governed by the Office of Combination Products (OCP). They must adhere to the most stringent pharmacovigilance requirements applicable to each component (drug, device, biologic).

4. ANDA Holders (Generic Drug Manufacturers)

Generic drug manufacturers must comply with 21 CFR Part 314.98, which mirrors the pharmacovigilance requirements for NDA holders.

5. Over-the-Counter (OTC) Drugs

For OTC drugs without an NDA or ANDA, companies must comply with the adverse event reporting requirements under 21 CFR Part 330.

6. How Pharma Companies Determine Applicability

Product Classification: A pharmaceutical company first determines whether their product is a drug, biologic, device, or combination product. The classification guides which set of FDA regulations they fall under.

FDA Product Approval Pathway: Companies must assess whether their product has an NDA, BLA, ANDA, or falls under the OTC monograph system. This determines which reporting and pharmacovigilance regulations apply.

Risk Profile and Post-Marketing Commitments: High-risk products may require additional FDA mandates such as Risk Evaluation and Mitigation Strategies (REMS) or specific post-marketing studies.

Consult FDA Guidance Documents: The FDA issues specific guidance documents to help companies understand reporting timelines, electronic submission requirements, and periodic safety reporting (e.g., E2E Pharmacovigilance Guidelines for periodic safety updates).

7. Electronic Submission Requirements

FDA mandates that safety reports (adverse events) be submitted electronically through the FDA Adverse Event Reporting System (FAERS) for drugs and biologics, and through the Electronic Medical Device Reporting (eMDR) for devices.

Conclusion:

Pharmaceutical companies determine which FDA pharmacovigilance regulations apply to them based on the type of product they manufacture and their market authorization status. They can consult the FDA Code of Federal Regulations (CFR), specific FDA guidance documents, and utilize regulatory support to ensure they meet all necessary requirements.