Regulatory authority

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Regulatory authority is an official body that governs and enforces laws and regulations related to development, approval, and oversight of drugs, medical devices, and other therapeutic products.

Definitions

ICH E6(R2)

1.49 Regulatory Authorities:
Bodies having the power to regulate. In the ICH GCP Guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections (see 1.29). These bodies are sometimes referred to as competent authorities [1].

History

Regulatory authorities emerged early in the 20th century in response to public health incidents (like diethylene glycol poisoning), prompting governments to establish regulations for drug safety and efficacy to meet the public need for standardized safety protocols.

Key agencies worldwide

Key agencies include the:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Japan's Pharmaceuticals and Medical Devices Agency (PMDA)

Regulatory submission

Typically, regulatory submission and approval consist of several distinct stages:

  1. Application. Sponsor submits required documents (e.g., IND, CTA, CTN) to regulatory authority. Application contains preclinical data, clinical trial protocols, investigator information, drug manufacturing details, etc.
  2. Review. Authority reviews submission to ensure the study is scientifically sound.
  3. Communication. Authority issues an official document (e.g. Approval letter, No Objection Letter, or Notification letter) indicating that the study can commence.

Investigational New Drug (IND) application in USA

Before beginning of a clinical trial, sponsor must submit an IND application. This includes preclinical data, proposed protocols, and manufacturing information.

Clinical Trial Application (CTA) in EU

In Europe, sponsors submit a CTA to national regulatory authorities for approval to conduct a clinical trial.

Regulatory approval

Approval is required before the commencement of a study to ensure that the trial is recognized by the relevant regulatory body and adheres to all required regulations. Documentation of formal approval depends on the territory and its legislation.

USA

The FDA does not issue a formal certificate upon approval of an Investigational New Drug (IND) application. Instead, the absence of a clinical hold after the 30-day review period effectively means the study is approved to proceed. Sponsors often receive a written communication (e.g., an acknowledgment letter) indicating the IND status.

European Union

When a Clinical Trial Application (CTA) is approved, the relevant national regulatory authority provides an official approval letter or notification. This document confirms that the trial can commence in that country.

Canada

After reviewing a Clinical Trial Application (CTA), Health Canada issues a No Objection Letter (NOL) if the trial is approved. This letter serves as official documentation that the study can begin.

Japan

Pharmaceuticals and Medical Devices Agency (PMDA) issues a notification letter indicating that the Clinical Trial Notification (CTN) has been accepted and the study can proceed.

See also

Another relevant pages

Links to this page

References

  1. ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023

External links

Regulatory application procedures by region


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