Registration of Pharmaceutical Products in Malaysia NVS Regulatory Services

Pharmaceutical, Cosmetic, Herbal or Supplement Registration in Malaysia

Registration of the above classes of product has recently become severely scrutinized by the Malaysia National Pharmaceutical Regulatory Agency (NPRA). NPRA or previously known as National Pharmaceutical Control Bureau is the government body tasked for the below functions.

  • evaluate any product registration of pharmaceutical nature in Malaysia
  • carry out test on the product before registration
  • evaluate all the technical documentation for registration
  • take random samples from the market for lab testing
  • manage all pharmaceutical product complaints and the Adverse Drug Reaction Monitoring

Throughout the body’s 39 years of existence in Malaysia, it has guided Malaysia to become a member of the PICS (Pharmaceutical Inspection Co-Operation Scheme), WHO Collaborating Centre and a leading member in the ASEAN region for pharmaceutical industry development. Following its growth, comes an increase in new requirements by the NPRA for registration of pharmaceuticals in Malaysia. This warrants a newer generation of regulatory consultants to keep up with the ever-changing landscape of pharmaceutical registration in Malaysia. NVS Regulatory Services has several consultants who are experienced in their own respective regulatory field be it from Generic to Herbal to Supplements to Biologicals and even Medical Device! The consultants are trained to be fast and precise for any regulatory advices. Do give the number below a call to enquire more and to get more information. 

 

MOTTO

To Provide Swift and Accurate Regulatory Advice

Do Contact Mr. Nithiya Raj Rajalingam at 6012-2960139//603-55133498
Or E-mail at nvs.regulatory@gmail.com

Services Offered in Malaysia & Singapore

Product Registration

  • Pharmaceutical Scheduled Poison
  • Pharmaceutical Non Scheduled Poison (OTC)
  • Pharmaceutical Health Supplement
  • Pharmaceutical Herbal Products
  • Pharmaceutical Cosmetic Products
  • Pharmaceutical Biologicals
  • Food Based Products
  • Medical Devices

License & Applications

  • Import License Application
  • Registration Renewals
  • Variations (Major & Minor)
  • Change of Manufacturing Site application

Consultation

  • Manufacturing Site GMP Inspection by Malaysia NPRA Consultation
  • Bio-Equivalence Centre Inspection by Malaysia NPRA Consultation
  • Pharmacovigilance Related Complaints Consultation
  • Food/Pharmaceutical Classification
  • Patent Search Consultation
  • Trademark Search Consultation