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  1. Jun 28, 2024 · Check product that registered or notified with NPRA. Carian produk yang berdaftar di NPRA.

  2. Jun 28, 2024 · A Certificate of Pharmaceutical Product which follows the format recommended by WHO shall be issued to locally manufactured products that are to be exported. For application of CPP, applicant shall fill in form BPFK 412.2: Permohonan Perakuan Keluaran Farmaseutikal.

  3. Jun 28, 2024 · Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials. Regulation Basic. Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts.

  4. Jun 23, 2024 · List of Product Renewal. Note to Applicant. The application for product renewal (also termed as re-registration of a product) shall only be submitted when all of the requirements for product registration have been complied with.

  5. 5 days ago · General Clinical Trial. 01. What is the regulatory authority with oversight for clinical trial in Malaysia? Malaysia has a single regulatory authority, the National Pharmaceutical Control Bureau (NPCB). For more details, please click here. The Centre for Investigational New Product is the unit in charge. 02.

  6. Jun 20, 2024 · Apakah badan yang berkuasa untuk percubaan klinikal di Malaysia? Malaysia mempunyai satu badan autoriti, iaitu Biro Pengawalan Farmaseutikal Kebangsaan (BPFK). Untuk maklumat lanjut klik klik di sini.

  7. Jun 13, 2024 · BPFK Surabaya melayani evaluasi peralatan pemantau dosis perorangan untuk TLD (thermoluminescent dosimetri) Card. BPFK Surabaya telah terdaftar sebagai Laboratorium Dosimetri Eksterna di BAPETEN dengan Surat Tanda Registrasi Nomor 008/K/DKKN/I/2017.

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