CRED ERP 25

02/07/2025

Specific considerations

Orphan diseases

•

US FDA

• Specific diseases / treatment modalities

TGA (Australia)

MHRA (UK)

• Oncology e.g. FDA Project Orbis

• ATMPs e.g. fast-track accelerated Ph1 CTAs in Spain

Participating Project Orbis Partners (POP)

Israel Ministry of Health Pharmaceutical Administration

Health Canada

Combination products

•

Paediatrics

•

ANVISA (Brazil)

SwissMedic

Accelerated approvals

•

HSA ( Singapore )

• Access to medicines in low and middle-income countries

The Organisation for Professionals in Regulatory Affairs

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General concepts to consider

WHO views on Regulatory Cooperation

Differentiation

•

Recognition

• Alignment, convergence & harmonisation vs divergence

Resources

•

Reliance / Work sharing

Prioritisation

•

Timing / sequencing

•

Confidence building Harmonisation/convergence Information sharing

• Governance and decision-making

Source: EFPIA: https://www.efpia.eu/media/554422/convergence-of-regulatory requirements-benefits-patients-and-society.pdf

Trends

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The Organisation for Professionals in Regulatory Affairs

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