Global regulatory advisory

1. According to an estimate by the World Health Organization (WTO) in 2016, 10% of drugs sold globally are falsified medicines. Those are often disguised as authentic medicines but may contain ingredients of bad or toxic quality, or in the wrong dosage. As they have not been properly checked for quality, safety and efficacy, they can pose a real risk to public health.
3. The UDI System is intended to provide a single, globally harmonized system for positive identification of medical devices. Healthcare professionals and patients will no longer have to access multiple, inconsistent, and incomplete sources in an attempt to identify a medical device and, its key attributes.

1. In 2019, the Chinese National Medical Products Administration (NMPA), formerly the CFDA, revised its pharmaceutical track and trace regulation, allowing the usage of either the GS1standard traceability codes or the former 20-digit "E-code". Companies are required to exchange all the information they generated with their supply chain partners, and report drug data to the National Drug Traceability Collaborative Service Platform and the National Drug Traceability Supervision System.
3. On October 15, 2019, the National Medical Products Administration (NMPA) issued a directive outlining the scope and timeline for implementing Unique Device Identification (UDI) for the initial batch of medical devices. Subsequently, in March 2021, revised Medical Device Supervision and Administration Regulations were promulgated, reinforcing the phased implementation of UDI by product category to enhance traceability.
  
  To standardize medical device identification and tighten lifecycle management, the NMPA formulated and issued the Rules on the Unique Identification System of Medical Devices, effective from October 1, 2019.

1. Since enforcement of the Drug Supply Chain Security Act (DSCSA) in 2017, FDA has implemented numerous requirements of the law to help trading partners build a more secure and transparent drug supply chain. The DSCSA requires manufacturers & re-packagers to encode product identifiers on prescription drug packages on the smallest individual saleable units.
  
  Enhanced drug distribution security requirements beginning August 30, 2023 – this is the compliance policy guideline and establishes a 1-year stabilization period allowing trading partners to meet the criteria for drug tracing at the package level. This extends the stabilization period until November 27, 2024.
3. The U.S. Food and Drug Administration (FDA) published a UDI final rule requiring all medical devices distributed in the U.S. to bear a Unique Device Identifier (UDI). A separate DI is needed for each variable of a device, such as size, color, or style, so the number of UDIs for a single type of device can add up quickly. Device labelers must also submit device data to FDA's Global Unique Device Identification Database (GUDID)

1. The EU Falsified Medicines Directive (EU-FMD) came into effect since February 2019. Prescription medicines sold in the EU market are required to carry a unique identifier and anti-tampering device. Market authorization holders and manufacturers are required to report serialization data to the EMVS repository system (EU-HUB). Wholesalers and pharmacies supplying medicines to the public need to scan the codes to verify the authenticity of product at the time of dispense.
3. Published in 2017, EU Medical Device Regulation 2017/745 (MDR) and the EU IVD Regulation 2017/746 (IVDR) now require that all devices being placed on the market in accordance with these Regulations will need to be assigned a Unique Device Identif ier (UDI) in order to facilitate product identification and traceability on the EU market.

1. Since the beginning of 2022, the United Arab Emirates (UAE) has been gradually implementing pharmaceutical serialization regulations. From January 2023 onward, serialization and aggregation have become mandatory, along with data reporting to the track-and-trace system "Tatmeen."