Industry & QUEST3+ System Main Page

Products Registration & Licensing System

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The 27th ASEAN Consultative Committee for Standards and Quality
Pharmaceutical Product Working Group (ACCSQ PPWG) will be held on 24-27 June 2019 at Hotel G Gurney, Penang, Malaysia
KAJIAN KEPUASAN PELANGGAN NPRA 2019
Soal selidik ini bertujuan mendapatkan maklumbalas pelanggan terhadap perkhidmatan yang disediakan oleh Bahagian Regulatori Farmasi Negara (NPRA)
Public Consultation On
Implementation Of Bioequivalence (BE) Study Requirements For New Drug Products Containing Scheduled Poison
Drug Registration Guidance Document : Second Edition – September 2016, revised January 2019
Announcements

Regulatory Information

Product Classification, QUEST3+ System Basic, ASEAN Guidance Documents, Guideline For The Submission Of Product Samples For Laboratory Testing & Clinical Trials.

Among the pharmacovigilance activities carried out by NPRA are adverse drug reaction (ADR) monitoring and screening of drug safety alerts. These activities allow identification of drug safety issues, which are reviewed in order to implement preventative measures. NPRA also communicates information on drug safety issues to healthcare professionals and the public, in our ongoing effort increase patient safety.

The submission of sample for laboratory testing is as part of the registration process.This guideline consists of the general and specific requirements for the submission of samples to the Centre for Quality Control for laboratory testing. The general requirements define the condition of the samples to be submitted whereas the specific requirements illustrate the additional details needed according to the category of product.

Good Laboratory Practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environment safety studies are planned, performed, monitored, recorded, archived and reported. The purpose of the Principles of GLP is to promote the development of quality data.

Any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s Licence, Import Licence or Wholesale Licnese. Licencing unit, Centre for Compliance and Licensing (CCL) involves in the activity of issuance of Licence.

A significant part of the quality of a finished product is dependent on the quality of the Active Pharmaceutical ingredients (APIs) used for its formulation. Thus, a proper system of qualification of suppliers is necessary to ensure a constant sourcing of APIs of appropriate quality and to safeguard the public health interests. This will be done through standardized quality assessment and inspection procedures.

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Product Categories

Browse Guidelines, Directives, Circulars, Announcements and Application Forms according to Product Categories

Cosmetics

Any preparation intended to be placed in contact with various external parts of the human body

Natural Products

 Traditional (General) & Traditional (Medium)


Generic Medicines

Bioequivalence (BE), Prescription (Full), Non-Prescription (Full & Abridge)

Biologics

Biological/Biotech/Biosimilar, Vaccines, Blood Products & Others


New Chemical Entity

New Chemical Entity/Radiopharmaceutical Substances, New Combination Products, Supplemental Products

Health Supplements

General, Functional (Medium) & Disease Risk Reduction (High)


Veterinary Medicines

Scheduled Poison, Non-Poison, Innovator/NCE



Combination Products

Drug-Medical Device And Medical Device-Drug Combination Products

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Thursday 16 May 2019, 15:41:55.
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