Steps for Regulatory and Pharmacovigilance Services in Vietnam

by Ddreg Pharma Regulatory Service | DDReg Pharma  There are two main aspects to consider for pharmacovigilance services in Vietnam:

1. Regulatory Authority:

• The National Center for Drug Information and Adverse Drug Reactions Monitoring Center (NDIADRMC) under the Ministry of Health (MOH) is the primary agency responsible for pharmacovigilance in Vietnam. 
• They collect, analyze, and assess adverse event reports, maintain a database, and communicate drug safety information.
• You can report adverse drug reactions (ADRs) directly to the NDIADRMC website.

2. Contract Pharmacovigilance Organizations (CROs):

• Several CROs offer pharmacovigilance services in Vietnam to assist companies in meeting regulatory requirements.
• These services include:
  • Adverse drug reaction reporting and management.
  • Signal detection and management.
  • Aggregate report writing.
  • Pharmacovigilance plan development.
  • Regulatory compliance guidance.

while Regulatory Services in Vietnam govern the authorization and compliance of therapeutic goods, upholding healthcare standards.

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Created on Apr 3rd 2024 04:08. Viewed 62 times.

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