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  1. National Pharmaceutical Regulatory Agency (NPRA) - Home. Recent Updates. Guidelines for the Establishment, Handling, Storage and Use of Chemical Reference Substances. Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum.

  2. Misi NPRA adalah menjamin kesihatan rakyat melalui kawalan regulatori ubat-ubatan dan kosmetik berlandaskan kecemerlangan saintifik. DAFTAR PRODUK ANDA SEKARANG Orang Awam

  3. 6 days ago · Regulation Basic. 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.

  4. The product / cosmetic under NPRA regulatory control status is subjected to changes according to regulatory update / needs. Produk / kosmetik di bawah status kawalan kawal selia NPRA tertakluk kepada perubahan mengikut kemas kini peraturan / keperluan.

  5. 1 day ago · The batch tested by NPRA found to contain Cadmium above allowable limit. Degree II recall at the point of sales. Ecorigin Plt. 4. 17 January 2023 . Xetec Tablet 10mg . MAL20040625AZ. Cetirizine Dihydrochloride 10mg. XE 20L 001. The batch tested by NPRA failed dissolution test and found to contain any secondary peak and Total impurities above ...

  6. 6 days ago · Step 1: Pre-submission of Application (Preparation) Step 2: Submission. Step 3: Screening. Step 4: Evaluation of Application. Step 5: Regulatory Outcome. Step 6: Post-Registration Process. National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Malaysia Drug Control Authority.

  7. Jul 2, 2015 · Beginning 1985, NPRA was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed.

  8. Products Search. Search Pharmaceutical, Complimentary & Alternative Products that registered with National Pharmaceutical Regulatory Agency, NPRA. You may also search cosmetic products notified with NPRA. Search Products. Consumer Information. Consumer Reporting of Side Effects to Medicines or Vaccines.

  9. QUEST 3+ Online Submission System enabled Product License Holder, Manufacturer, Importer, Re-packer, Reseller and other related users to conduct secured online transactions for product registration, variation, licensing, market sampling, renewal and other transactions.

  10. National Pharmaceutical Regulatory Agency (NPRA) Disclaimer : Pharmaceutical Services Programme, Ministry of Health Malaysia shall not be liable for any loss or damage resulting from the use of information in this portal.

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