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
Pedoman Penilaian Obat Berbasis Sel Manusia
Berita Negara Tahun 2020 Nomor 812
Konsiderans
Menimbang:
bahwa untuk melindungi masyarakat dari peredaran obat berbasis sel manusia yang tidak memenuhi syarat, dalam pelaksanaan registrasi diperlukan penilaian terhadap aspek keamanan, khasiat, dan mutu;
bahwa untuk menjamin obat berbasis sel manusia telah memenuhi aspek keamanan, khasiat, dan mutu, perlu menetapkan pedoman yang mengatur mengenai penilaian obat berbasis sel manusia;
bahwa sesuai dengan ketentuan Pasal 4 huruf a Peraturan Presiden Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan, salah satu kewenangan Badan Pengawas Obat dan Makanan yaitu menerbitkan izin edar produk dan sertifikat sesuai dengan standar dan persyaratan keamanan, khasiat/manfaat, dan mutu;
bahwa berdasarkan pertimbangan sebagaimana dimaksud dalam huruf a, huruf b, dan huruf c, perlu menetapkan Peraturan Badan Pengawas Obat dan Makanan tentang Pedoman Penilaian Obat Berbasis Sel Manusia;
Jika ada kendala link download error, kesalahan informasi, informasi kurang lengkap, kritik, saran, atau menambahkan informasi, silakan hubungi kami melalui email paralegal@paralegal.id.
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Peraturan Pilihan
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Sekretariat Jenderal Komisi Nasional Hak Asasi Manusia
