Government & Industry Regulations
Government & Regulatory Compliance Challenges
New laws and regulations are increasing dramatically for organizations across all markets worldwide, and compliance with them is essential for business success. When most people think of compliance, they relate it to the healthcare or financial services sector. However, compliance is a requirement that affects every industry. In fact, it has become vital in manufacturing and transportation, where companies are operating and selling in an increasingly globalized marketplace. This is especially true for companies in the Pharmaceuticals & Life Sciences, Food, Beverage & Tobacco, Medical Device and Retail, Fashion & Consumer Goods sectors. When it comes to government and industry regulations, Engineering Industries eXcellence can provide expert consulting, holistic digital solutions and implementation services covering manufacturing operations and supply chain compliance.
Supply Chain Traceability Regulations
European Union:
The European Food Safety Authority (EFSA) and European Medicines Agency (EMA) are government agencies of the European Union (EU) responsible for protecting public health by defining and enforcing regulations for pharmaceutical drugs, sanitary standards and the food and beverage industry.
EU Pharmaceutical & Life Sciences:
Life science companies must navigate a complex network of regulations when operating or selling in Europe. The European Union’s Falsified Medicines Directive (FMD) took effect in February 2019. This legislation requires pharmaceutical companies to verify the authenticity of each medicinal product manufactured or distributed in Europe. This item-level serialization poses some serious operational challenges for each of the stakeholders.
Our Digital Supply Chain (Tracking & Tracing) solutions enable compliance via the efficient serialization of products, simplification of the required 2D barcode system and risk reduction across the supply chain. Our solutions enable the European Union central database hub, which is operated by the European Medicines Verification Organization (EMVO), to connect to all National Medicine Verification Systems (NMVS) within the European Union as well as with the greater European Economic Area (EEA) and Switzerland. As a result, data exchange and reporting is simplified across country lines and government agencies.
EU Battery Manufacturing: The EU Battery Passport
To ensure that the expansion of the battery manufacturing market is accomplished in the most sustainable way, the European Union announced an update to its 2006 Battery Directive in July 2023, defining new requirements for producers and distributors, including the so-named battery passport, a digital record system that will enable the transfer of key information between parties across the supply chain. Starting from February 1, 2027, every industrial and electric vehicle (EV) battery with a capacity of over 2 kWh will require a digital battery passport in order to be listed in the European market. The party placing the battery on the EU market, regardless of its location, will be responsible to ensure that all data required is entered in the digital record correctly and kept updated.
Our Digital Supply Chain (Tracking & Tracing) solutions can help global battery manufacturers selling and distributing to the EU market implement the right solutions, integrate them with their existing technology ecosystems and become compliant for business ahead of the new deadline and in a cost-efficient way.
Product Lifecycle Coverage: The Ecodesign for Sustainable Products Regulation (ESPR) & Digital Product Passport (DPP)
The Ecodesign for Sustainable Products Regulation (ESPR) is a European Union initiative aimed at making products on the EU market more sustainable, durable, reusable and energy-efficient. Proposed in March 2022, the regulation builds on the existing Ecodesign Directive, expanding its focus beyond energy-related products to a wide range of consumer goods. This includes textiles, furniture, electronics and packaging, among others.
The ESPR introduces significant advancements in sustainable product design, including the Digital Product Passport (DPP), a pivotal feature aimed at increasing transparency and sustainability in the EU market. It provides a digital record of essential product information—such as origin, composition, environmental impact and resource efficiency—accessible throughout a product’s lifecycle. This data helps consumers make informed, sustainable choices, supports manufacturers in achieving circularity goals and enables recyclers to better handle end-of-life products. By promoting traceability and facilitating sustainable practices, the DPP is instrumental in advancing the EU's circular economy and environmental objectives.
United States of America:
The U.S. marketplace has specific regulatory guidelines outlined and enforced by the federal Food & Drug Administration (FDA) to protect public health.
U.S. Pharmaceutical & Life Sciences:
In the United States, the FDA’s Drug Supply Chain Security Act (DSCSA) outlines the steps the pharmaceutical industry needs to take to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The DSCSA also defines a system with a timeline for reaching full-item traceability by November 27, 2024. Each stage requires different levels of compliance by stakeholders.
The regulation's final compliance deadline requires that transaction information must include the unique product identifier at the package level for all the packages included in the transaction. In addition, trading partners need to have systems and processes in place to promptly respond with the transaction information and transaction statement for a product, upon a request by an Authorized Trading Partner or the FDA. This request supports product verification as well as investigation of suspects or illegitimate products. To learn more, read our Drug Supply Chain Security Act (DSCSA) Unpacked guide.
Our Digital Supply Chain (Tracking & Tracing) solutions help pharmaceutical and life science manufacturers, wholesale distributors, re-packagers, third-party logistics firms and dispensers operating within the U.S. maintain a recorded chain of control and custody that can be easily reported to government agencies.
U.S. Food & Beverage Manufacturing:
Companies in the U.S. food and beverage manufacturing sector must follow the regulations from the Food Safety Modernization Act (FSMA). The FSMA enables the FDA to better protect public health by strengthening the food safety system. The law was enacted in 2011 in response to excessive reports of foodborne illnesses in the U.S., not to mention the billions of dollars in recalls, lost sales and legal affairs that it cost the American food and beverage industry as a result.
The FSMA aims to ensure that U.S. food is safe by preventing contamination of the food supply. The law applies to human food as well as to food for animals. Seven rules have been outlined and tied to specific actions at each point in the global supply chain to reduce contamination. Among others, the regulation includes precise standards for growing, harvesting, packing and storing produce; it also defines transportation requirements, supplier verifications and third-party certification. In the case of contamination, the FSMA demands that reporting must be provided to the FDA within 24 hours in order to ensure a quick response and prevent harm to consumers.
Our Digital Supply Chain (Tracking & Tracing) solutions help food and beverage producers, processors, packagers, shippers and third-party partners maintain a recorded chain of control and traceability across the product lifecycle that can easily be reported to government agencies and other authorized stakeholders across the supply chain.
Brazil:
The Agência Nacional de Vigilância Sanitária (ANVISA) is the Brazilian government agency responsible for the regulation of pharmaceutical drugs, sanitary standards and the food industry.
Brazil Pharmaceutical & Life Sciences:
Brazil continues to define its pharmaceutical serialization and traceability regulations. In 2017, ANVISA released the RDC-157 law, providing guidance for the implementation of a National Medicine Control System (SNCM), as well as the mechanism and procedures for drug tracking. The country and pharmaceutical stakeholders who manufacture in or import to Brazil are all expected to comply with the requirements set out by the regulation, which is being implementing through a series of phases. The drug value chain encompasses drug tracking from the moment of activation (manufacturing or import) of the individual drug until the moment of its dispense to the consumer. The scope of the SNCM tracking ends following the dispensing of the serialized drug, so the consumer or patient is considered to be a post-consumption participant in the value chain.
Our Digital Supply Chain (Tracking & Tracing) team is advising and supporting Brazilian pharmaceutical and life science leaders throughout the different phases of this regulation's implementation in order to help them get ahead of the curve. Our solutions enable the exchange of serialization data quickly and securely across the extended supply chain network and with the SNCM. As a result, we can enable fast and secure regulatory reporting between production, government and business partners.
Middle East & Asia:
In order to combat the growing business for counterfeit goods, governments in the Middle East and Asia are establishing increasing regulations across different industries. Regulatory government agencies such as the National Agency for Drug and Food Control of Indonesia (Badan Pengawas Obat dan Makanan or BPOM), the Saudi Food and Drug Authority (SFDA) and the Turkish Ministry of Food Agriculture and Livestock (İlaç Takip Sistemi or İTS) have been highly active in protecting their communities through regulations and controls that ensure the safety of food, pharmaceuticals, medical devices and other highly-counterfeited products, especially those being imported.
To comply with many of the regulations being put or already in place, pharmaceutical and food companies doing business in the Middle East and Asia must ensure that every product is properly labeled, serialized and traced starting from manufacturing to warehousing and all the way to its final sale. Our Digital Supply Chain (Tracking & Tracing) solutions can provide the needed serialization capabilities and traceability required to comply with country-specific regulations, ensuring safe products without creating production delays.
National Systems for Product Serialization
Counterfeit goods are big business and they mean big loss in taxes. Some fakes, such as alcohol or pharmaceuticals, can have harmful effects on the health and safety of the population as well. Governments around the world continue to enact traceability legislation for the protection of their constituents. To abide by these laws, industry players are turning to Digital Supply Chain (Tracking & Tracing) technologies to digitalize their compliance processes and streamline reporting without disrupting company operations or the supply of goods. Governments, however, have to be prepared to collect, manage and connect the volumes of product traceability data they require via these same regulations from different players across the supply chain.
The Engineering Industries eXcellence team has helped a number of different governments worldwide create national systems for serialization. As a result, governments can ensure that companies follow the traceability regulations enacted. With full visibility, governments can track and trace all moving goods within their national borders from the product origin to the end consumer. Our serialization repository solutions also enable serial number management and standardization for easier customs control of imported goods. With experience from both sides, only our team of experts can enable digital compliance for industry players and the governments to which they answer.
Engineering's Advantage
Engineering Industries eXcellence has expert teams not only highly knowledgeable about the different regional and industry-specific regulations with which industrial organizations have to comply, but who can also deliver the digital solutions needed to help both companies and governments achieve compliance quickly and cost-effectively. In addition to guaranteeing compliance with regulations and documentation requirements, our solutions track and trace digitally serialized products, ensure product authenticity and integrity, enable visibility and traceability throughout manufacturing and the supply chain, and facilitate the identification and removal of illegitimate products before they make it to market.
