electricsheepafrica/drug-registration-authorization

Drug Registration & Market Authorization Dataset

Abstract

This dataset provides 30,000 simulated drug registration dossier observations (10,000 per scenario) across three NRA capacity levels in sub-Saharan Africa. Each record represents one registration application with 30+ variables including product type, dossier quality, registration timeline, outcome, reliance pathway usage, and patient access impact. Three scenarios: strong NRA with reliance (38-day median, 91% approval), developing NRA (191-day, 55%), minimal NRA (592-day, 18%).

This dataset is entirely simulated. It must not be used for regulatory or policy decisions.

1. Introduction

Drug registration is the gateway to legal medicine access. In SSA, registration timelines range from months (ML3+ NRAs with reliance pathways) to years (ML1 countries). Only 10-30% of WHO essential medicines are registered in the lowest-income African countries. AMRH and WHO reliance/recognition pathways aim to accelerate access while maintaining quality standards.

2. Parameterization Evidence (v2.0)

Parameter	Value Used	Source	Year
Median registration 12-36 months SSA	12-36 mo	WHO	2023
EML coverage 10-30% in LICs	10-30%	Lancet Commission	2017
WHO PQ ~600 products	~600	WHO PQ Programme	2023
AMRH joint assessment 30-50% faster	30-50%	AMRH/AU-NEPAD	2023
African pharma market ~$30B	$30B	UNCTAD	2022

3. Validation

4. Usage

from datasets import load_dataset
dataset = load_dataset("electricsheepafrica/drug-registration-authorization", "developing_nra_standard")
df = dataset["train"].to_pandas()
print(df.groupby('outcome').size())

5. References

1. WHO (2023). Global landscape of pharmaceutical regulation.
2. AMRH/AU-NEPAD. African Medicines Regulatory Harmonization.
3. Lancet Commission (2017). Essential Medicines.
4. WHO Prequalification Programme.
5. UNCTAD (2022). African pharmaceutical market.

Citation

@dataset{esa_drug_reg_2025,
  title   = {Drug Registration and Market Authorization Dataset},
  author  = {{Electric Sheep Africa}},
  year    = {2025},
  publisher = {Hugging Face},
  url     = {https://huggingface.co/datasets/electricsheepafrica/drug-registration-authorization}
}

License

CC-BY-4.0