Regulatory compliance is a crucial topic for pharmaceuticals because they have to comply with various regulations and requirements that undergo changes and updates.
We make a brief overview and point out the highlights of 2021. Moreover, we turn our sights on the upcoming regulations and updates.
Starting the retrospection with DSCSA: FDA confirmed the DSCSA 2023 Interoperability Deadline would remain as planned. The requirements for whole interoperable electronic track and trace systems have to be fully implemented by manufacturers and trading partners by November 2023. The new requirements are Challenging for the supply chain participants and affect different aspects of the track and trace process. Concerning the serialization process, the transaction information (TI) must include the product identifier (PI), the exchange of data will be transmitted to EPCIS to enhance the drug security and minimize the risk of counterfeiting.
Towards the goal to reduce the number of alerts in the system and thus the resources required for alert investigation, EMVO implemented its Alert Management System (AMS). It allows all stakeholders to investigate alerts and enable pharmaceutical companies to interact securely and anonymously.
From 26th of May 2021, the Medical Devices Regulation is fully applicable earlier in the year. The transition to MDR is associated with new requirements and changes, which affect the whole industry. Regarding the changes, they start from the new scope, definition of MD and affect the obligations of manufacturers. The European database of medical devices, EUDAMED, will be fully functional in the mid of 2022.
In 2021 Russia expanded the scope of track and trace products, including pharmaceutical products the nutritional supplements. The end date of the pilot project under CRPT operation in mid 2022.
Another exciting news was that the deadline for the traceability system`s development in Bahrain came to its end at the end of 2021. The manufacturers also have to go through the NHRA (National health Regulatory Authority) to register their new drugs and then be provided with the mandate to sell their products. The aggregation requirements are expected to be announced in 2022.
As we are talk about new traceability systems, the BRAZIL Anvisa has approved its final Normative Instruction (NI 100). The mandatory serialization deadline is 28th April 2022, addressing three critical requirements towards pharma manufacturers, distributors and dispensers – all prescription medicines must be serialized; all manufacturers and importers must have a “serialization plan” in the portal of the National Medicine Control System (SNCM); all supply chain stakeholders must submit product event reports to the SNCM.
The issue with drug counterfeiting inclines the Kazakhstan government to implement a pharma track and trace for the serialization of all medicines. At the beginning of 2021, the Kazakh Ministry of Health published a pilot guideline for product marking and traceability. Till July 2023, all of the drug products on the market must be serialized.
The United Arab Emirates officially published a legislative decree, settling out the critical milestones of Tatmeen (traceability system) and introducing the serialization for pharmaceuticals, medical devices and blood products. Since the end of last year, UAE has already started to implement the 2D Barcode and serialization requirements, setting the 13th of December as a deadline for data reporting to Tatmeen.