IFPMA whitepaper: How assessment reports enable regulatory reliance in pharma

Assessment reports from reference national regulatory authorities sit at the center of regulatory reliance. WHO Good Reliance Practices and EMA Article 58-style pathways show how relying NRAs can reuse prior scientific work without surrendering final accountability.

Key Takeaways

• WHO Good Reliance Practices (TRS 1033 Annex 10) define reliance as giving significant weight to another trusted authority's assessments while retaining national decision accountability.
• WHO guidance states relying NRAs should use assessment reports as the primary information source for reliance-based reviews.
• EMA European Public Assessment Reports (EPARs) are a widely used public assessment-report model for human medicines.
• Industry white papers argue for clearer PAR/NPAR terminology, but claims about any single company's filing timeline are not assumed here without a primary filing.

What problem does regulatory reliance solve?

Many national regulatory authorities lack the staff capacity to repeat every quality, nonclinical, and clinical assessment already completed by a stringent reference agency. WHO Good Reliance Practices promote using prior assessments to free capacity for vigilance, inspections, and local-context decisions.

Reliance is not automatic recognition. The relying NRA still issues its own decision and remains accountable for it.

Why are assessment reports the linchpin?

An assessment report captures the reference NRA's benefit-risk reasoning across quality, safety, and efficacy. WHO's GRelP text emphasizes that relying authorities should treat these reports as the primary source when applying reliance, especially when written in a usable common language.

Where only redacted public assessment reports exist, manufacturers may need to facilitate sharing of unredacted reports under confidentiality arrangements—an enabler discussed across WHO materials and industry practice notes.

Which public models already exist?

EMA's European Public Assessment Report (EPAR) system is a mature public assessment-report model. WHO prequalification public assessment reports (WHOPARs) adapt a similar structure for prequalified products. Teams comparing formats can start from EMA product EPARs and WHO PQ documentation rather than secondary blogs.

• WHO GRelP: high-level principles and definitions
• EMA EPARs: product-level public assessment narratives
• WHO PQ WHOPARs: prequalification assessment summaries

How does EMA support non-EU reliance pathways?

EMA's scientific opinions for medicines intended for use outside the EU (historically associated with Article 58 / EU-Medicines for all style pathways) create an assessment package that non-EU regulators can use. EMA's 2025 annual-report communications also noted positive opinions for medicines intended for use outside the EU, underscoring the continuing relevance of cross-border assessment reuse.

What remains contested or implementation-heavy?

Legal barriers to sharing unredacted reports, inconsistent report structure, language translation, and sameness-of-product verification still slow reliance in practice. WHO materials acknowledge these barriers; they are operational constraints, not proof that reliance fails as a concept.

What should regulatory affairs teams do with this?

Map which reference EPARs or WHOPARs support each planned national filing, confirm product sameness, and document the local benefit-risk addendum the relying NRA still needs. Avoid citing non-allowlisted trade-association PDFs as the sole evidence when WHO and EMA primaries already establish the mechanism.

How WHO Good Reliance Practices describe assessment-report use

WHO's Good Reliance Practices text is explicit: relying national regulatory authorities should use assessment reports as the primary source of information for assessments whenever those reports are available in a usable form. The guidance also recognizes that confidentiality, language, and incomplete public redactions remain practical barriers.

In practice, that means a reliance dossier should include the reference authority's assessment narrative, confirmation that the product is the same as the one assessed, and a short local benefit-risk addendum covering epidemiology, medical practice, and supply-chain controls that only the relying NRA can judge.

EMA EPARs and WHO prequalification public assessment reports are the two most commonly cited public templates. Teams should not treat a trade-association white paper as a substitute for those primary documents when the question is whether a specific product assessment pack is complete enough for unilateral reliance.

Where unredacted reports are required, manufacturers and NRAs typically need confidentiality arrangements before sharing. WHO materials frame that sharing as an efficiency tool, not as a transfer of sovereignty: the relying authority still signs its own decision.

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Frequently Asked Questions

What is regulatory reliance according to WHO?

WHO defines reliance as a process where a national regulatory authority gives significant weight to assessments performed by another trusted authority or institution while remaining independent and accountable for its own decision.

Why do assessment reports matter for reliance?

Assessment reports summarize the reference authority's evaluation of quality, safety, and efficacy and the benefit-risk rationale. WHO guidance treats them as the primary information source for reliance-based reviews.

Is reliance the same as automatic recognition?

No. Under WHO Good Reliance Practices, the relying authority still makes its own decision and remains responsible for that decision even when it uses another authority's work.

Primary Sources

1. WHO: Good reliance practices (TRS 1033 Annex 10)
2. WHO PDF: TRS 1033 Annex 10 Good Reliance Practices
3. WHO news: GRP and GRelP guidance announcement
4. EMA annual reports hub (EPARs and related assessment outputs)