Aspek Hukum dan Farmasi dalam Regulasi Real-World Evidence (RWE) untuk Persetujuan Obat: Tantangan Implementasi di Indonesia
DOI:
https://doi.org/10.38035/dhps.v2i4.1843Keywords:
Real-World Evidence, Regulasi obat, Hukum farmasi, Sains regulatori, Data kesehatanAbstract
Penelitian ini mengkaji aspek hukum dan farmasi dalam implementasi Real-World Evidence (RWE) pada regulasi persetujuan obat di Indonesia. Seiring kerangka regulasi global yang semakin menerima RWE berdampingan dengan uji klinis tradisional, Indonesia menghadapi tantangan signifikan dalam mengadopsi pendekatan ini. Melalui penelitian hukum doktrinal dan analisis kualitatif, studi ini mengidentifikasi empat tantangan utama: kesenjangan regulasi dalam kerangka persetujuan obat Indonesia yang tidak secara eksplisit mengakui RWE; infrastruktur data kesehatan yang tidak memadai; kapasitas sumber daya manusia yang terbatas dalam metodologi RWE; serta persoalan etika dan perlindungan data. Penelitian ini mengusulkan peta jalan implementasi bertahap meliputi pengembangan pedoman RWE spesifik, kemajuan infrastruktur, pengembangan kapasitas profesional, dan harmonisasi hukum antara regulasi obat dan kerangka perlindungan data. Temuan menunjukkan bahwa kolaborasi multi-pemangku kepentingan strategis antara BPOM, Kementerian Kesehatan, fasilitas kesehatan, industri farmasi, dan institusi akademik sangat penting untuk keberhasilan implementasi RWE, yang berpotensi meningkatkan akses obat sambil mempertahankan standar keamanan dalam sistem kesehatan Indonesia.
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