Industry & QUEST3+ System Main Page
NOTIFICATION EXEMPTION
QUEST CONFIGURATION
TECHNICAL EVALUATION SUMMARY
CERTIFICATE/ LICENCE COLLECTION CENTRE
RECENT UPDATES
[Updated November 2024] Product Classification Form - NPRA/413/01-3 |
Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application |
Direktif berkenaan larangan penggunaan chloroform/chloroform spirit sebagai pengawet dalam produk farmaseutikal, produk semula jadi dan produk suplemen kesihatan |
MADRAC Members |
Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance |
CALENDAR ACTIVITIES
| 20 Nov 2024; 08:30AM - 04:15PM MOPI Training 2024: Good Submission Practice 2.0 for Generic Medicines |
| 12 Nov 2024; 08:00AM - 05:00PM MOPI Training 2024: Good Distribution Practice for the Regulated Industry |
| 15 Oct 2024; 08:00AM - 05:00PM MOPI Training 2024: A practical approach to ISO 13485 QMS for medical devices |
| 25 Sep 2024; 08:00AM - 05:00PM MOPI Training 2024: Contamination Control - How to Develop an Effective Contamination Control Strategy |
| 10 Sep 2024; 08:00AM - 05:00PM MOPI Training 2024: Supply chain management and Supplier QA program-Application of QRM principles |
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
