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  • 890207115225
    890207115225 updated an article
    Editing
    Application Forms Biologics

     

    Document Name MS Word PDF Updated
    GLP Compliance Form Download   15 May 2024
    Checklist for Manual Submission Download   9 June 2022
    CGTPs Stage I & II Manual Screening Form Download   9 June 2022
    Appendix 1 (Format for Clinical Studies Conducted/Ongoing/Planned in Malaysia); Appendix 2 (Format for Synopsis of Individual Studies) Download   2 May 2024

     

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  • nabilashaffie
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    Editing
    [CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

    The NPRA and Bioequivalence & Ethics Committee Section (BEEC) is in the process of updating and modernising the Malaysian Guideline for Bioequivalence Inspection and would like to seek your inputs to further improve on the clarity and transparency of its contents. We invite you to provide your inputs at the following link: https://tinyurl.com/MGBEI-UPC 

     

    We also invite you to complete a short survey (found in the link above) related to the publication of inspection compliance status on the NPRA website. Please read through the instructions on how to provide your inputs carefully to ensure that your opinions are captured. 

     

    We would like to thank you for your time and valued inputs in this public consultation.

     

    Public consultation period: 8 April 2024 - 6 May 2024

     

    UPDATE:-

    The NPRA and BEEC Section would like to thank you for your feedback and inputs during the public consultation of the Malaysian Guideline for Bioequivalence Inspection 2nd Edition. We would also like to take the opportunity to thank you for your feedback in the short survey to publish our inspection outcomes on the NPRA website. We are currently reviewing your valued inputs and will publish the outcome of the public consultation and survey in a formal report.

     

    Thank you.

     

    -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     

    NPRA dan BEEC sedang dalam proses mengemaskini Malaysian Guideline for Bioequivalence Inspection dan ingin mendapatkan pendapat anda untuk menambahbaik isi kandungan garispanduan tersebut agar lebih jelas dan telus. Kami menjemput anda untuk memberi input di pautan berikut: https://tinyurl.com/MGBEI-UPC 

     

    Kami juga menjemput anda untuk melengkapkan kaji selidik ringkas (di pautan yang sama) berkaitan dengan penerbitan status kepatuhan hasil pemeriksaan di laman sesawang NPRA. Sila baca arahan dengan teliti berhubung cara untuk memberi input anda bagi memastikan pendapat anda diterima oleh kami.

     

    Kami ingin mengucapkan terima kasih atas masa dan pendapat yang anda beri dalam seranta awam ini.

     

    Tempoh seranta awam: 8 April 2024 - 6 Mei 2024

     

    KEMASKINI:-

    Pihak NPRA dan Seksyen BEEC ingin mengucapkan terima kasih atas maklum balas dan input anda semasa seranta awam Malaysian Guideline for Bioequivalence Inspection Edisi Kedua. Kami juga ingin mengambil kesempatan ini untuk mengucapkan terima kasih atas maklum balas anda dalam soal selidik ringkas berhubung penerbitan hasil pemeriksaan di laman sesawang NPRA. Kami sedang meneliti semua maklum balas yang diterima dan akan menerbitkan hasil seranta awam dan soal selidik dalam laporan rasmi.

     

    Terima kasih.

     

     

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  • nabilashaffie
    nabilashaffie updated an article
    Editing
    [CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

    The NPRA and Bioequivalence & Ethics Committee Section (BEEC) is in the process of updating and modernising the Malaysian Guideline for Bioequivalence Inspection and would like to seek your inputs to further improve on the clarity and transparency of its contents. We invite you to provide your inputs at the following link: https://tinyurl.com/MGBEI-UPC 

     

    We also invite you to complete a short survey (found in the link above) related to the publication of inspection compliance status on the NPRA website. Please read through the instructions on how to provide your inputs carefully to ensure that your opinions are captured. 

     

    We would like to thank you for your time and valued inputs in this public consultation.

     

    Public consultation period: 8 April 2024 - 6 May 2024

     

    UPDATE:-

    The NPRA and BEEC Section would like to thank you for your feedback and inputs during the public consultation of the Malaysian Guideline for Bioequivalence Inspection 2nd Edition. We would also like to take the opportunity to thank you for your feedback in the short survey to publish our inspection outcomes on the NPRA website. We are currently reviewing your valued inputs and will publish the outcome of the public consultation and survey in a formal report.

     

    Thank you.

     

    -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     

    NPRA dan BEEC sedang dalam proses mengemaskini Malaysian Guideline for Bioequivalence Inspection dan ingin mendapatkan pendapat anda untuk menambahbaik isi kandungan garispanduan tersebut agar lebih jelas dan telus. Kami menjemput anda untuk memberi input di pautan berikut: https://tinyurl.com/MGBEI-UPC 

     

    Kami juga menjemput anda untuk melengkapkan kaji selidik ringkas (di pautan yang sama) berkaitan dengan penerbitan status kepatuhan hasil pemeriksaan di laman sesawang NPRA. Sila baca arahan dengan teliti berhubung cara untuk memberi input anda bagi memastikan pendapat anda diterima oleh kami.

     

    Kami ingin mengucapkan terima kasih atas masa dan pendapat yang anda beri dalam seranta awam ini.

     

    Tempoh seranta awam: 8 April 2024 - 6 Mei 2024

     

    KEMASKINI:-

    Pihak NPRA dan Seksyen BEEC ingin mengucapkan terima kasih atas maklum balas dan input anda semasa seranta awam Malaysian Guideline for Bioequivalence Inspection Edisi Kedua. Kami juga ingin mengambil kesempatan ini untuk mengucapkan terima kasih atas maklum balas anda dalam soal selidik ringkas berhubung penerbitan hasil pemeriksaan di laman sesawang NPRA. Kami sedang meneliti semua maklum balas yang diterima dan akan menerbitkan hasil seranta awam dan soal selidik dalam laporan rasmi.

     

    Terima kasih.

     

     

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  • nabilashaffie
    nabilashaffie updated an article
    Editing
    [CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

    The NPRA and Bioequivalence & Ethics Committee Section (BEEC) is in the process of updating and modernising the Malaysian Guideline for Bioequivalence Inspection and would like to seek your inputs to further improve on the clarity and transparency of its contents. We invite you to provide your inputs at the following link: https://tinyurl.com/MGBEI-UPC 

     

    We also invite you to complete a short survey (found in the link above) related to the publication of inspection compliance status on the NPRA website. Please read through the instructions on how to provide your inputs carefully to ensure that your opinions are captured. 

     

    We would like to thank you for your time and valued inputs in this public consultation.

     

    Public consultation period: 8 April 2024 - 6 May 2024

     

    UPDATE:-

    The NPRA and BEEC Section would like to thank you for your feedback and inputs during the public consultation of the Malaysian Guideline for Bioequivalence Inspection 2nd Edition. We would also like to take the opportunity to thank you for your feedback in the short survey to publish our inspection outcomes on the NPRA website. We are currently reviewing your valued inputs and will publish the outcome of the public consultation and survey in a formal report.

     

    Thank you.

     

    -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     

    NPRA dan BEEC sedang dalam proses mengemaskini Malaysian Guideline for Bioequivalence Inspection dan ingin mendapatkan pendapat anda untuk menambahbaik isi kandungan garispanduan tersebut agar lebih jelas dan telus. Kami menjemput anda untuk memberi input di pautan berikut: https://tinyurl.com/MGBEI-UPC 

     

    Kami juga menjemput anda untuk melengkapkan kaji selidik ringkas (di pautan yang sama) berkaitan dengan penerbitan status kepatuhan hasil pemeriksaan di laman sesawang NPRA. Sila baca arahan dengan teliti berhubung cara untuk memberi input anda bagi memastikan pendapat anda diterima oleh kami.

     

    Kami ingin mengucapkan terima kasih atas masa dan pendapat yang anda beri dalam seranta awam ini.

     

    Tempoh seranta awam: 8 April 2024 - 6 Mei 2024

     

    KEMASKINI:-

    Pihak NPRA dan Seksyen BEEC ingin mengucapkan terima kasih atas maklum balas dan input anda semasa seranta awam Malaysian Guideline for Bioequivalence Inspection Edisi Kedua. Kami juga ingin mengambil kesempatan ini untuk mengucapkan terima kasih atas maklum balas anda dalam soal selidik ringkas berhubung penerbitan hasil pemeriksaan di laman sesawang NPRA. Kami sedang meneliti semua maklum balas yang diterima dan akan menerbitkan hasil seranta awam dan soal selidik dalam laporan rasmi.

     

     

    Terima kasih.

     

     

    Continue Reading →
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  • nabilashaffie
    nabilashaffie updated an article
    Editing
    [CLOSED] Public Consultation: Malaysian Guideline for Bioequivalence Inspection 2nd Edition

    The NPRA and Bioequivalence & Ethics Committee Section (BEEC) is in the process of updating and modernising the Malaysian Guideline for Bioequivalence Inspection and would like to seek your inputs to further improve on the clarity and transparency of its contents. We invite you to provide your inputs at the following link: https://tinyurl.com/MGBEI-UPC 

     

    We also invite you to complete a short survey (found in the link above) related to the publication of inspection compliance status on the NPRA website. Please read through the instructions on how to provide your inputs carefully to ensure that your opinions are captured. 

     

    We would like to thank you for your time and valued inputs in this public consultation.

     

    Public consultation period: 8 April 2024 - 6 May 2024

     

    UPDATE:-

     

    The NPRA and BEEC Section would like to thank you for your feedback and inputs during the public consultation of the Malaysian Guideline for Bioequivalence Inspection 2nd Edition. We would also like to take the opportunity to thank you for your feedback in the short survey to publish our inspection outcomes on the NPRA website. We are currently reviewing your valued inputs and will publish the outcome of the public consultation and survey in a formal report.

     

    Thank you.

     

    -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

     

    NPRA dan BEEC sedang dalam proses mengemaskini Malaysian Guideline for Bioequivalence Inspection dan ingin mendapatkan pendapat anda untuk menambahbaik isi kandungan garispanduan tersebut agar lebih jelas dan telus. Kami menjemput anda untuk memberi input di pautan berikut: https://tinyurl.com/MGBEI-UPC 

     

    Kami juga menjemput anda untuk melengkapkan kaji selidik ringkas (di pautan yang sama) berkaitan dengan penerbitan status kepatuhan hasil pemeriksaan di laman sesawang NPRA. Sila baca arahan dengan teliti berhubung cara untuk memberi input anda bagi memastikan pendapat anda diterima oleh kami.

     

    Kami ingin mengucapkan terima kasih atas masa dan pendapat yang anda beri dalam seranta awam ini.

     

    Tempoh seranta awam: 8 April 2024 - 6 Mei 2024

     

    KEMASKINI:-

    Pihak NPRA dan Seksyen BEEC ingin mengucapkan terima kasih atas maklum balas dan input anda semasa seranta awam Malaysian Guideline for Bioequivalence Inspection Edisi Kedua. Kami juga ingin mengambil kesempatan ini untuk mengucapkan terima kasih atas maklum balas anda dalam soal selidik ringkas berhubung penerbitan hasil pemeriksaan di laman sesawang NPRA. Kami sedang meneliti semua maklum balas yang diterima dan akan menerbitkan hasil seranta awam dan soal selidik dalam laporan rasmi.

     

     

    Terima kasih.

     

     

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  • mfareed
    mfareed updated an article
    Editing
    KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

     

    20240506_014614073_iOS-3

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    KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

     

    20240506_014614073_iOS-3

    20240506_014614073_iOS-3

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    KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

     

    20240506_014614073_iOS-3

    20240506_014614073_iOS-3

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    mfareed updated an article
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    KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

     

    20240506_014614073_iOS-3

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    mfareed updated an article
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    KENYATAAN MEDIA KEMENTERIAN KESIHATAN MALAYSIA - MAJLIS MENANDATANGANI SEMULA MEMORANDUM PERSEFAHAMAN ANTARA KERAJAAN MALAYSIA DAN THE HEALTH SCIENCES AUTHORITY (HSA) OF SINGAPORE BAGI KERJASAMA DALAM BIDANG REGULATORI FARMASEUTIKAL PADA 6 MEI 2024

     

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