China’s Push for Safer, Smarter Medicines: The Role of Drug Traceability Codes

Apr 11, 2025 |

On March 19, 2025, China’s National Healthcare Security Administration (NHSA) dropped an important announcement that’s shaking up how medications are...

Strengthening Global Health Supply Chains: USAID’s Approach to Enabling Traceability in Africa

Mar 14, 2025 |

Ensuring the authenticity and safety of medical products is a critical priority in global health supply chains. The U.S. Agency for International...

Navigating Misalignment Exception Management Under DSCSA: Challenges and Solutions

Feb 28, 2025 |

The U.S. Drug Supply Chain Security Act (DSCSA) aims to enhance pharmaceutical traceability, but misalignment exceptions remain a persistent challenge....

Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications

Feb 7, 2025 | Serialization, Regulations

Reference: 19th Legislature - 10th Permanent Commission - Summary report no. 247 of 26/11/2024 (Accessed on February 6, 2025....

Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers

Jan 24, 2025 | Serialization, Regulations

Italy is embarking on a significant shift in its pharmaceutical regulation by transitioning from the Bollino system to the European Union’s Falsified...

Pharmaceutical Serialization in the GCC: Progress, Challenges, and Future Directions

Jan 17, 2025 | Serialization

Pharmaceutical serialization, a cornerstone of supply chain security, is rapidly advancing across the Gulf Cooperation Council (GCC) countries. This...

Overview of Indonesia’s Pharmaceutical Serialization Regulations

Jan 3, 2025 | Serialization, Pharmaceutical, Regulations, Compliance

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) or Badan POM, also known as the Indonesian FDA, is a government agency in...

US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s

Dec 20, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

The US DSCSA, enacted in 2013, aims to create a system for tracking prescription drugs as they are distributed within the United States. The act is...

The Importance of Master Data Management in Pharmaceutical Track & Trace

Dec 13, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Serialization involves assigning serial numbers to products or packaging units, requiring a defined set of attributes for tracking and tracing. Master...

CSV in Pharmaceuticals: Challenges and Solutions

Dec 6, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Pharmaceutical manufacturers face several challenges specific to Computer System Validation (CSV) due to the industry's stringent regulatory and...