Apakah pilihan yang boleh dimasukkan dalam Laporan Penilaian Klinikal untuk menangani kebimbangan keselamatan dan prestasi yang relevan mengenai produk kombinasi ubat-peranti perubatan untuk produk kombinasi dengan kelulusan dari negara rujukan? | What are the options that can to be included in Clinical Evaluation Report to address relevant safety and performance concerns regarding the drug-medical device combination product for a combination product with approval from reference countries?

Penilaian klinikal boleh termasuk maklumat berikut:

  1. Data kajian p_ost-market clinical follow-up (PMCF)_ bagi produk kombinasi
  2. Data kajian human factors (HF) bagi produk kombinasi
  3. Petikan dari gambaran keseluruhan klinikal common technical document (CTD) bagi produk kombinasi
Untuk pertanyaan lanjut, sila hubungi 
BAHAGIAN KAWALAN PRA PASARAN (BKPP)
03 - 8230 0376

It may include the following information:

  1. Data on post-market clinical follow-up studies for combination product
  2. Data on human factors study for the combination product
  3. Excerpts from the drug common technical document (CTD) clinical overview for the combination products
For further inquiries, please contact
PRE-MARKET CONTROL DIVISION (BKPP)
03 - 8230 0376