During this interim period, NPRA have implemented mitigation plan for foreign GMP inspection scheduled for the year 2020 to ensure registration process (new registration and/or renewal) are uninterrupted.

Where possible, other pathways are being used to facilitate registration process for pending foreign GMP inspection applications including requesting additional information from applicants and existing inspection reports for facility that had been inspected by other competent authorities (e.g. Pharmaceutical Inspection Co-operation Scheme (PIC/S), ASEAN Listed Inspection Services).

However, foreign GMP inspection will be resumed once COVID-19 pandemic had subside. Product Registration Holder (PRH) will be informed from time to time regarding re-scheduling of affected foreign GMP inspections. Inspection will be prioritized based on the risk whereby all manufacturing facilities will be evaluated using risk-based approach to determine the need for on-site inspection.

1. Opening Meeting.
2. Outcome of documentation evaluation and further discussion/ document requested if it is deemed necessary.
3. The manufacturer conducts a virtual tour on the facility.
4. Closing Meeting.

1. Formatted to be as a readable Portable Document Format (PDF).
2. Provided in a clearly organized manner, consistent with the document request.
3. Identified in a way that enables the inspector to understand each document’s contents from its title or file name without having to open the document.
4. The options for sharing documentation range from secured email to secured cloud storage solutions restricted to specific participants and made available only during the inspections.
5. The document sharing platform should provide the appropriate level of security while also allowing auditors to easily locate, review, and annotate documents.
6. Documents also can be shared in real time during the virtual inspection through the video communication platform.
7. Documents also might be shipped through traditional mail or courier services, either in paper form or on electronic storage media.
8. The manufacturer should ensure that any electronic files are accessible by the inspector.

1. Video communication platforms can be used during many aspects of a virtual inspection, including chat, video- and audio-conferencing. Examples are Microsoft Teams, Cisco WebEx, and Zoom.
2. Care should be taken to ensure that the camera produces a stable picture that is easy to view.
3. Additional audio tools may be necessary for the person operating the camera during the virtual tour.
4. In areas of the facility where the Wi-Fi signal may not be strong enough to broadcast a live virtual tour, consider whether it might be useful to install devices to amplify the signal or prepare a pre-recorded video.
5. No recordings are allowed throughout the inspection process.

GMP certificate will be issued upon application and the certificate shall specify type of DiA (Remote Inspection) conducted. The GMP validity for Remote Inspection is 2 years.

The manufacturer is given 5 working days to provide feedback/ correspondence to documents requested. If additional time is needed, it should be discussed and agreed with the respective GMP inspector(s).

The process of foreign GMP Inspection application is unchanged despite the pandemic. If PRH wish to put in application for any foreign GMP inspection, they can submit ‘Borang Permohonan Pemeriksaan APB Luar Negara (BPFK-501)’ along with processing fee of RM 5,000.00 to the GMP Section, CCQC.

Yes, application submission will not be impacted by COVID-19 travel restrictions. NPRA will inform involved PRH’s of any updates from time to time.

The payment structure for Remote Inspection consists of two parts, in which all costs shall be borne by the applicant as follows:

7.1 Processing Fee:

7.1.1 Payment of a processing fee of RM 5,000.00 upon application.

7.1.2 The processing fee is non-refundable.

7.2 Inspection Fee:

7.2.1 Payment of an inspection fee of RM 20,000.00 upon issuance of invoice by NPRA.

7.2.2 NPRA will issue an invoice to the company once inspection date is confirmed.

7.2.3 The payment shall be made using a banker’s cheque payable to: Name : BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN/ AGENSI REGULATORI FARMASI NEGARA, KEMENTERIAN KESIHATAN MALAYSIA

7.2.4 The inspection fee is non-refundable under any circumstances.

NPRA telah mengenal pasti pelan mitigasi bagi pemeriksaan APB premis pengilang luar negara yang telah dijadualkan untuk tahun 2020 bagi memastikan proses regulatori; pendaftaran / pendaftaran semula produk berjalan dengan lancar sewaktu krisis. Pihak pemegang pendaftaran produk [Product Registration Holder (PRH)] yang terlibat akan dihubungi oleh PKKK untuk tindakan selanjutnya.

Pendekatan yang diambil oleh NPRA bagi melancarkan proses pendaftaran produk bagi pemeriksaan luar negara yang tertangguh adalah termasuk mendapatkan maklumat tambahan daripada pihak PRH dan penilaian lanjut ke atas bukti pematuhan APB bagi pengilang luar negara yang pernah diperiksa oleh pihak regulatori berwibawa (Contohnya; Pharmaceutical Inspection Co-operation Scheme (PIC/S), ASEAN Listed Inspection Services).

Walau bagaimanapun, pemeriksaan APB ke atas premis pengilang luar negara tetap akan dijalankan selepas isu pandemik Covid-19 berada dalam keadaan terkawal. Pihak PRH akan dimaklumkan akan penjadualan semula premis-premis yang terlibat yang mana penjadualan semula akan dijalankan berdasarkan penilaian risiko dan keperluan negara.

Sijil APB akan dikeluarkan sekiranya pihak pengilang mengemukakan borang permohonan dan jenis DiA (Remote Inspection) akan dinyatakan dengan jelas pada sijil APB berkenaan.
Tempoh sah sijil APB bagi Remote Inspection adalah 2 tahun.

Pihak pengilang diberi 5 hari bekerja untuk mengemukakan semua dokumen / maklum balas bagi setiap koresponden. Sekiranya pihak pengilang memerlukan lebih masa untuk
menyediakan dokumen / maklum balas, perkara ini perlu dibincang lanjut bersama pemeriksa.

Tiada perubahan pada proses kerja permohonan pemeriksaan APB luar negara sedia ada. PRH masih boleh mengemukakan Borang Permohonan Pemeriksaan APB Luar Negara (BPFK-501) berserta bayaran fi pemprosesan sebanyak RM5,000.00 kepada Seksyen APB, PKKK.

Ya, Permohonan Pemeriksaan APB Luar Negara (BPFK-501) boleh dikemukakan dan ia tidak dipengaruhi oleh larangan perjalanan susulan pandemik COVID-19. Pihak NPRA akan maklumkan sebarang maklumat terkini kepada PRH yang terlibat dari masa ke masa.

Ya, Permohonan Pemeriksaan APB Luar Negara (BPFK-501) boleh dikemukakan dan ia tidak dipengaruhi oleh larangan perjalanan susulan pandemik COVID-19. Pihak NPRA akan maklumkan sebarang maklumat terkini kepada PRH yang terlibat dari masa ke masa.

Struktur bayaran fi bagi Remote Inspection terdiri daripada Fi Pemprosesan dan Fi
Pemeriksaan di mana semua fi perlu ditanggung sepenuhnya oleh PRH.

7.1 Fi Pemprosesan:

7.1.1 Bayaran Fi Pemprosesan sebanyak RM 5,000.00 perlu dikemukakan bersama Permohonan Pemeriksaan APB Luar Negara (BPFK-501).
7.1.2 Bayaran Fi Pemprosesan tidak akan dikembalikan.

7.2 Fi Pemeriksaan:

7.2.1 Bayaran Fi Pemeriksaan sebanyak RM 20,000.00 perlu dibuat setelah menerima invois daripada pihak NPRA.
7.2.2 Invois berkenaan akan dikeluarkan kepada PRH setelah tarikh pemeriksaan ditetapkan.
7.2.3 Bayaran Fi Pemeriksaan perlu dibuat menerusi banker’s cheque yang dibayar kepada:

Nama : BIRO PENGAWALAN FARMASEUTIKAL KEBANGSAAN/ AGENSI REGULATORI FARMASI NEGARA, KEMENTERIAN KESIHATAN MALAYSIA

7.2.4 Bayaran Fi Pemeriksaan tidak akan dikembalikan.