Industry & QUEST3+ System Main Page
NOTIFICATION EXEMPTION
QUEST CONFIGURATION
TECHNICAL EVALUATION SUMMARY
CERTIFICATE/ LICENCE COLLECTION CENTRE
RECENT UPDATES
Biosimilar Approved |
Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness |
Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use |
[Updated] Loperamide: Risk of Acute Pancreatitis |
[Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy |
CALENDAR ACTIVITIES
| 18 Jan 2024; 09:00AM - 05:30PM ISPE Online GDP Seminar : Module 1 (QMS & Documentation ) |
| 18 Dec 2023; 08:00AM - 05:00PM TMHS Industry Training 2023: PQR and Verification |
| 03 Oct 2023; 08:30AM - 05:00PM Latihan Industri: Ke Arah Pelaksanaan Pengujian Kawalan Kualiti Ke Atas Bahan Mentah Herba Bagi Pengilang Produk Semulajadi |
| 15 Aug 2023; 08:00AM - 05:00PM National Regulatory Conference (NRC) 2023 |
| 22 May 2023; 09:00AM - 05:00PM ISPE Malaysia Education Series: Strengthening GDP Fundamentals |
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.
Any matters related to inspection of bioequivalence (BE) centres & listing of ethics committee (EC) with Drug Control Authority (DCA).
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 License, Import License or Wholesale License. Licensing & Certification Section is involved in the activity of issuance of License.
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.
Medicinal gases are gases or gas mixtures intended for the administration to patients for medicinal purpose such as anaesthetic, therapeutic, prophylactic and diagnostic use.
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
