PENGSTRUKTURAN SEMULA BAHAGIAN REGULATORI FARMASI NEGARA KEMENTERIAN KESIHATAN MALAYSIA

Untuk makluman YBhg. Datuk / Dato’ / Datin / Dr. / Tuan / Puan, Bahagian Regulatori Farmasi Negara (NPRA), Kementerian Kesihatan Malaysia (KKM) akan melaksanakan proses pengstrukturan semula pada bulan Disember 2019. Struktur baru NPRA yang akan berkuatkuasa mulai 02 Disember 2019 tersebut adalah seperti di Lampiran A

Sehubungan itu, dimaklumkan bahawa proses ini akan turut melibatkan pergerakan dalaman sebilangan anggota NPRA berdasarkan lokasi baharu setiap pusat / seksyen di dalam premis NPRA. Oleh itu, mengambil kira pergerakan dalaman serta perubahan nombor telefon yang akan berlaku dalam tempoh ini, komunikasi melalui saluran emel adalah amat digalakkan untuk memastikan kelancaran perkhidmatan.

RESTRUCTURING OF THE NATIONAL PHARMACEUTICAL REGULATORY AGENCY MINISTRY OF HEALTH MALAYSIA

With reference to the subject matter as above, kindly be informed that the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health (MOH) Malaysia will be undergoing a restructuring exercise. This restructuring exercise is estimated to take place beginning December 2019. The new structure which will be effective as of 2^nd December 2019 is attached herewith for your kind reference (refer Attachment A).

Kindly note that this restructuring exercise will involve the relocation of certain NPRA officers in accordance to the new sections / centres within the premise of NPRA. As communication via telephone may be a challenge due to this relocation process, we strongly encourage communications to be done via e-mail during this period to ensure the continuity of services provided.

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Quality Control Centre has maintained theMS ISO/IEC 17025:2005

accreditation certificate by Jabatan Standards Malaysia on 30 August 2018.
Accreditation will be valid until 30 November 2020

SCAM TELEPHONE CALLSNOTICE

Recently, the NPRA has received reports from the public regarding scam telephone calls that
were made by individuals who claimed to be NPRA officers.

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NPRA mission is to safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

Consumers

ConSERF, AEFI Reporting, RiMUP, Product Cancellation & etc

Health Professionals

Safety Alert, Reporting ADR, MADRAC, Product Complaints, Publications

Industries

Product Registration, QUEST3+ System, Guideline Central, Application Forms, FAQs.

PRODUCT SEARCH

Check product status including pharmaceutical, natural & cosmetic products

Product Status

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

To report a suspected side effect or adverse drug reaction (ADR) to any medicine or vaccine

Report ADR as Consumers

Report ADR as Health Care Professional

ANNOUNCEMENTS
RECENT UPDATES
PRESS RELEASE
DIRECTIVES & CIRCULARS
SAFETY ALERTS
CALENDAR ACTIVITIES

05Dec

Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees

13Nov

Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees

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List of Renewal Approved Veterinary Products
published on 2019-12-10

Additional Indications Approved
published on 2019-12-10

New Products Approved
published on 2019-12-10

Second Source and Replacement Products
published on 2019-12-04

Direktif untuk semua produk yang mengandungi carbimazole atau methimazole (thiamazole): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pankreatitis akut (acute pancreatitis) dan pengukuhan maklumat keselamatan berkaitan risiko kecacatan kongenital (congenital malformation)
published on 2019-12-04

More Recent Updates

05Dec

Kenyataan Akhbar KPK 5 Disember 2019 – ISU PANGGIL BALIK TIGA PRODUK METFORMIN DARIPADA PASARAN SINGAPURA

31Oct

MAKLUMAT TERKINI BERKAITAN PENILAIAN SEMULA PRODUK BERDAFTAR YANG MENGANDUNGI BAHAN AKTIF RANITIDINE BERIKUTAN PENGESANAN IMPURITI N-NITROSODIMETHYLANIBE (NDMA)

01Oct

Kenyataan Akhbar KPK 30 Sept 2019 -Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

View All Press Release

04Dec

Direktif untuk semua produk yang mengandungi carbimazole atau methimazole (thiamazole): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko pankreatitis akut (acute pancreatitis) dan pengukuhan maklumat keselamatan berkaitan risiko kecacatan kongenital (congenital malformation)

04Dec

Direktif untuk semua produk yang mengandungi loperamide: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan unmasking Brugada syndrome dengan pengambilan dos berlebihan

14Oct

Keperluan Acknowledgement Receipt/ Endorsement Letter bagi pendaftaran baru/ pendaftaran semula produk kombinasi ubat-peranti perubatan (Drug-Medical Device Combination)

View All Directives & Circulars

26Nov

Retinoids: Updated measures for pregnancy prevention during retinoids use

26Nov

FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

30Oct

Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

View All Safety Alerts

18 Nov 2019;
08:00AM - 05:00PM
Good Distribution Practices for the Regulated Industry

20 Nov 2019;
08:00AM - 05:00PM
Supply Chain Management

02 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Effective Communication at the Workplace

03 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Reasoning and Decision Making

04 Dec 2019;
08:00AM - 05:00PM
Career Development Course : Managing Change – assessing the resistance and readiness

View Full Calendar

QUEST3+ System Registration ProcessHow to register as a user in QUEST3+ system?

Quality Control Centre has maintained theMS ISO/IEC 17025:2005

SCAM TELEPHONE CALLSNOTICE

Consumers

Health Professionals

Industries

PRODUCT SEARCH

REPORTING OF SIDE EFFECTS TO MEDICINES OR VACCINES

MAKLUMAT TERKINI STATUS PRODUK RANITIDINE BERKAITAN IMPURITI N-NITROSODIMETHYLAMINE (NDMA) [Kemaskini:05/12/2019]

Update of Guidance Notes for API Information for Product Registration - Version 4.0 (December 2019)

HSA-NPRA Generic Medicines Work Sharing Initiative

Soalan-soalan Lazim (FAQ): Impuriti NDMA di dalam Produk Ranitidine

Traditional, Health Supplement & Cosmetics Manufacturer: Regulatory Act upon Manufacturer with Unpaid GMP Inspection Fees

Pharmaceutical, Radiopharmaceutical & Veterinary Products Manufacturer: Prepaid GMP Inspection Fees

Kenyataan Akhbar KPK 5 Disember 2019 – ISU PANGGIL BALIK TIGA PRODUK METFORMIN DARIPADA PASARAN SINGAPURA

MAKLUMAT TERKINI BERKAITAN PENILAIAN SEMULA PRODUK BERDAFTAR YANG MENGANDUNGI BAHAN AKTIF RANITIDINE BERIKUTAN PENGESANAN IMPURITI N-NITROSODIMETHYLANIBE (NDMA)

Kenyataan Akhbar KPK 30 Sept 2019 -Produk-Produk Kosmetik Yang Dikesan Mengandungi Racun Berjadual

Direktif untuk semua produk yang mengandungi loperamide: Pengemaskinian sisip bungkusan dengan maklumat keselamatan berkaitan unmasking Brugada syndrome dengan pengambilan dos berlebihan

Keperluan Acknowledgement Receipt/ Endorsement Letter bagi pendaftaran baru/ pendaftaran semula produk kombinasi ubat-peranti perubatan (Drug-Medical Device Combination)

Retinoids: Updated measures for pregnancy prevention during retinoids use

FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

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