Compliance Best Practices

Overview of regulatory Reliance Pathways

Compliance Best Practices Hits: 55

OVERVIEW OF REGULATORY RELIANCE PATHWAYS

  1. Purpose & Scope
    • Purpose:To guide applicants on how to use regulatory reliance pathways to obtain Marketing Authorization (MA) for human medicinal products in Tanzania.
    • Objective:To accelerate marketing authorization for human medicinal products using established reliance mechanisms—ensuring faster access to essential, high-quality medicines in Tanzania.
    • Scope:Applies to new MA applications for products already approved by TMDA, AMA, WHO, EMA, EAC-MRH, SADC-MRH, or NRAs with WHO Maturity Level 3/4 and WLAs.
  2. Legal Basis
  • Anchored in Section 5(2)(f) of the Tanzania Medicines and Medical Devices Act, Cap 219, allowing TMDA to rely on assessments from trusted regulatory bodies.
  1. Key Definitions
  • Reliance:TMDA gives significant weight to decisions from other recognized regulatory authorities but retains final responsibility.
  • RRA:Recognized Regulatory Authority (e.g., EMA, WHO PQ).
  • WLA:WHO Listed Authority.
  • Sameness:Identical product characteristics and dossier content as approved by an RRA.
  1. Reliance Pathways

Pathway

Description

Abridged Review

Shortened review based on already-assessed data (prior rigorous RRA review). TMDA reviews selected modules.

Verification of Sameness

Confirms the product and dossier submitted to TMDA are identical to that assessed and approved by an RRA.

Recognition

TMDA accepts decisions from an RRA directly, guided by formal agreements (can be mutual/unilateral).

Work-Sharing

TMDA collaborates with AMA, EAC-MRH, SADC-MRH, etc., for joint assessments and common decisions.

 APPLICATION PROCESS & DOCUMENT SUBMISSION

  1. Applicant Requirements

Step

Action

1

Choose the reliance pathway (abridged, sameness, recognition, work-sharing).

2

Submit a Declaration of Sameness Letter (Appendix III) in Module 1.2 of the CTD.

3

Include Appendix I & II (consent form and sameness summary) in Module 1.10.3.

4

Justify proposed reliance pathway and clearly identify referenced sections of the CTD.

  1. Specific Document Requirements

Abridged Review:

  • Follow TMDA’s guideline for submission of FPPs approved by EMA or WHO-WLAs dossiers
  • Focus on abridged modules: manufacturing, stability, product info, etc.

Verification of Sameness:

  • Submit:
  • Unredacted assessment report from RRA.
  • Filled Consent to Share Form (Appendix I).
  • CTD dossier approved by RRA.
  • Complete Summary of Quality & BE Review form(Sameness Summary) (Appendix II).
    • All RRA-approved variations must be reflected.
    • Pending (unapproved) variations will disqualify the dossier for reliance.

 

  1. TMDA Review Process

- Submit complete dossier via TMDA online portal 

Scenario

Outcome

Complete and valid reliance documents

TMDA proceeds with proposed reliance pathway.

Incomplete or missing documentation

TMDA issues screening queries to the applicant.

Failure to comply or respond

TMDA defaults to full independent review.

 

  1. Additional Notes
  • TMDA may request further clarification at any stage.
  • If unredacted assessment reports aren't received within 3 months, full review applies.
  • Consent forms enable TMDA to directly request assessments if not provid ed by applicant.
  1. BENEFITS
  • Faster access to life-saving medicines
  • Reduces duplication and review time
  • Strengthens regional collaboration
  • Enhances use of global best regulatory practices
  1. References