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International Dossier Evaluation – Streamlining Global Submissions

  • mcpharma01
  • Dec 19, 2025
  • 4 min read

Table of Contents


Introduction

International Dossier Evaluation is the systematic, evidence-based appraisal of a Common Technical Document (CTD/eCTD) by national regulatory authorities (NRAs) to confirm the safety, efficacy and quality of a health product before approval. Harmonised guidelines from the ICH, EMA, FDA, WHO and SAHPRA increasingly promote work-sharing, reliance and electronic formats, allowing well-prepared dossiers to move faster across borders.


This article explains the principles, benefits and challenges of international dossier review and shows how MC Pharma’s regulatory team helps sponsors navigate each stage from technical gap analysis to post-approval life-cycle management.


Globe covered with international country flags representing global regulatory affairs and international dossier submissions

What is International Dossier Evaluation?

An international dossier is the full CTD or eCTD package submitted to an NRA for marketing authorisation, comprising five modules that cover administrative data, quality, non-clinical and clinical evidence (ICH, 2003) (ich.org). Dossier evaluation is the scientific and regulatory assessment of this file to decide whether public-health standards are met (Kolabtree, 2021) (kolabtree.com).


Global Harmonisation: CTD & eCTD

CTD Frameworks

ICH M4 created a common format recognised in the EU, US, Japan and many low- and middle-income countries, reducing duplicative compilation (ICH, 2003) (ich.org).


eCTD Transition

Electronic publishing adds structured XML backbones, hyper-links and validation rules that speed up review cycles and life-cycle tracking (WHO, 2023) (cdn.who.int).



Evaluation Pathways & Timelines

Region

Standard timeline*

Reliance / accelerated options

EMA (EU)

210 days active review under the Centralised Procedure (EMA, 2025) (ema.europa.eu)

Accelerated assessment ≤ 150-200 workingdays for public-health priority medicines (EMA, 2025) (ema.europa.eu)

FDA (US)

10-month standard cycle; Complete-Response Letter issued if deficiencies remain (FDA, 2024) (fda.gov)

Priority Review = 6 months; Real-Time Oncology Review, etc.

WHO

n/a (global norm-setting body)

Collaborative Registration Procedure (CRP) shares WHO PQ assessment with NRAs, cutting approval to 60-90 days (WHO, 2024) (extranet.who.int)

SAHPRA (South Africa)

200-350 days for full review

Abridged/verified review within 90-180 days using recognised reference authority reports (SAHPRA, 2024) (sahpra.org.za)

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*Clock-stops for sponsor questions excluded.


Why Dossier Evaluation Matters

  1. Patient safety - ensures robust benefit–risk evidence before supply (WHO, 2023) (cdn.who.int).

  2. Regulatory efficiency - harmonised templates allow NRAs to focus on critical data, trimming redundant review (EMA, 2025) (ema.europa.eu).

  3. Market access & cost savings - effective reliance can shorten African approvals by >50 % (Azatyan, 2023) (cdn.who.int); continental frameworks under the African Medicines Agency will deepen this cooperation (AUDA-NEPAD, 2025) (nepad.org).


MC Pharma’s Role in International Dossier Evaluation

  1. Gap analysis & CTD authoring – senior pharmacists benchmark your draft against ICH M4Q/M4S/M4E and SAHPRA reliance criteria.

  2. eCTD publishing & validation – in-house EXTedo® experts structure, hyperlink and run technical validation to eliminate errors before upload.

  3. Reference-authority bridging – we compile comparative tables showing alignment with EMA/FDA assessment reports to qualify for abridged review in South Africa or other SADC markets.

  4. Life-cycle management – MC Pharma tracks sequence updates, variations and renewals so the dossier stays compliant across jurisdictions.

  5. Training & strategic advice – workshops on Good Reliance Practices (GRP) and dossier readiness for African NRAs.


For service details see our Regulatory Intelligence and eCTD Management pages.


Practical Submission Tips

  1. Align Module 1 early - regional forms cause most clock-stops; pre-validate with each target NRA.

  2. Leverage public assessment reports - copy EMA’s European Public Assessment Report (EPAR) structure to demonstrate consistency.

  3. Use a master data backbone - regulatory information management (RIM) software reduces version-control errors.

  4. Plan for reliance - collect certified unredacted assessment reports from reference authorities at time of first approval; SAHPRA requires them in Module 1.10 (SAHPRA, 2024) (sahpra.org.za).

  5. Maintain an audit trail - regulators increasingly request e-signatures and change logs.


Frequently Asked Questions (FAQs)

  1. What is an international dossier?

    1. A harmonised CTD or eCTD package containing quality, non-clinical and clinical data that supports marketing authorisation in multiple regions.

  2. How does reliance shorten dossier review?

    1. By allowing an NRA to use another trusted agency’s full assessment report, reducing duplicate scientific work and trimming timelines by months.

  3. Is the CTD compulsory in South Africa?

    1. Yes. SAHPRA mandates CTD or eCTD format for all new chemical entities, generics and, biological medicines.

  4. What documents are critical for an abridged review?

    1. Certified unredacted assessment reports, GMP certificates, risk-management plans and final approved labelling from the reference authority.

  5. How can MC Pharma help with multi-country submissions?

    1. We prepare region-specific Module 1s, publish compliant eCTDs and coordinate simultaneous filings while managing all NRA queries.


Works Cited

  1. European Medicines Agency. (2025). The evaluation of medicines: step-by-step. (ema.europa.eu)

  2. European Medicines Agency. (2025). Accelerated assessment. (ema.europa.eu)

  3. Food and Drug Administration. (2024). FDA’s drug review process. (fda.gov)

  4. ICH. (2003). M4: Common Technical Document (CTD) guideline. (ich.org)

  5. Kolabtree. (2021). What is a regulatory dossier and what does it contain? (kolabtree.com)

  6. South African Health Products Regulatory Authority. (2024). Reliance guideline (SAHPGL-BAU-01 v4). (sahpra.org.za)

  7. World Health Organization. (2023). Good Reliance Practices technical briefing. (cdn.who.int)

  8. World Health Organization. (2024). Collaborative procedure for accelerated registration of IVDs. (extranet.who.int)

  9. Azatyan, S. (2023). WHO efforts to promote reliance. (cdn.who.int)

  10. AUDA-NEPAD. (2025). Continental regulatory reliance framework for the African Medicines Agency. (nepad.org)


Need help turning your draft dossier into an approval-ready eCTD?


Why choose MC Pharma?


With over 26 years of experience in navigating South Africa’s complex regulatory landscape, MC Pharma is your strategic partner for patient safety, regulatory excellence, and market success.


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