Proses pengilangan telah disemak bagi produk kombinasi yang telah mendapat kelulusan dari negara rujukan. Adakah pemohon perlu mengemukakan maklumat itu kepada MDA untuk kelulusan semula? | Manufacturing process has been reviewed for combination products that has obtained approval from reference countries. Does the applicant have to submit the information to MDA for approval again?

Keperluan proses pengilangan hanya boleh dikecualikan jika komponen peranti perubatan dibungkus bersama komponen ubat utamanya dan telah mendapat kelulusan atau kelulusan pemasaran sebagai peranti perubatan di negara rujukan. Produk gabungan ubat-peranti perubatan yang merupakan satu entiti tunggal perlu memasukkan maklumat proses pengilangan seperti yang dinyatakan dalam dokumen.

The requirements on manufacturing process can ONLY be excluded if the ancillary medical device is co-packaged together with its primary drug component AND received approval or marketing clearance as a medical device in reference countries. A single entity drug-medical device combination product is required to include the Manufacturing Process information as outlined in the dossier.