SERIALIZATION & BEYOND...

Read an overview of the basics of the European Medical Regulation (EU MDR)

Serialization requirements in Russia are among if not the most complex in the world. Not only is the timeline very tight - October 1, 2019 for the 12 high-cost nosologies and January 1, 2020 for the rest of the medicinal products

Managed by the CRPT, the Crypto verification is the one of the main ingredients of the drug track & trace requirements in Russia.

NPMA publishes new guidance documents for 2022 serialization compliance.

See a highlight of 13 articles the parliamentary working group has made up to fight against drug shortages in France.

PDSA advocates the creation of a sector-neutral governance body and the development of an interoperability model for the 2023 DSCSA enhanced drug distribution security requirements.

By October 2019, SFDA will require aggregation of the different level of packaging for pharmaceutical products for enhanced drug traceability in the pharma supply chain in Saudi.

When the Healthcare Distribution Alliance (HDA) imagined the Verification Router Service (VRS) concept, the intent was to design a solution that – when built according to VRS specification – would create an ecosystem where different VRS solutions would be interoperable.

In this blog post, we explore aggregation, what it is and how it's done and take a closer look at the parent child relationship in the pharmaceutical supply chain.

Tianna Umann, Cross Domain & Blockchain Solution Architect, Microsoft, discusses Blockchain Technology for Serialization and the robust solutions that have been co-developed by Adents and Microsoft to comply with US and EU regulatory requirements.

As of February 26, 2019, the Medicines and Healthcare products Regulatory Agency (MHRA) has published an update of the guidance note regarding the regulation of medicines, medical devices, and clinical trials if there’s no Brexit deal on March 29, 2019.

In a serialization project, the accountable QA expert is key across the whole process to mitigate risks and ensure permanent alignment with the applicable quality system and authorities requirements.

In depth discussion on pharma digitalization and how it’s influencing the future of medicine in labs around the world today.

Why integrity in the supply chain is so important, and the collaboration between Adents and Microsoft

The Saudi Food & Drug Authority (SFDA) requested that by the January 7, 2019 deadline all stakeholders (manufacturers, warehouses, pharmacies, medical and dispense centers) register and start reporting all transactions for drug packages placed on the Saudi market to Drug Track & Trace System (DTTS)

Russian Regulatory Updates from the Adents Team

The Adents Team discusses Supply Chain Management track from the ISPE Annual Conference

On October 24, 2018, FDA issued the following guidance document: Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs (Draft Guidance).

Manufacturer Serialization Readiness Survey Results toward DSCSA Implementation, and Verification Router (VRS) Service

As part of HDA’s VRS task force, Adents successfully completed end-to-end testing for Verification Request routing including Look-up Directory synchronization. Adents VRS, developed in partnership with Microsoft, is the unique solution currently tested by 4 of the top 5 largest Pharma wholesalers in the US.

The FDA has issued one draft and two final DSCSA guidance documents

Each passing day brings the pharmaceutical industry closer to the inevitable deadline of February 9, 2019 and the enforcement of serialization, track and trace and reporting requirements imposed by the European Falsified Medicines Directive (FMD) 2011/62/EU to many stakeholders at different levels of the pharmaceutical supply chain.

Adents is pleased to delve into the UDI market for Medical Devices, joining forces with Keyence and DNE Consulting.

At Adents, we consider blockchain to be the best long-term technology for a Verification Router Service to meet the US DSCSA requirements, but we understand that it is not a quick and easy path to navigate.

Did you know that on average, 60 million pharmaceutical saleable product returns, equaling $7-8 billion dollars, occur each year in the US market? This year, the establishment of shared standards for sales stream reintegration has become vital for the pharmaceutical industry.

Blockchain's capabilities will impact all industries and business value will therefore increase, according to Gartner’s latest Trend Insight Report on “Blockchain-Based Transformation”.

The EU pharma industry loses the equivalent of nearly 7% in sales per year due to counterfeit drugs which amounts to 26,9bn Euros annually.

New technologies like Blockchain, Triage bots and artificial intelligence (AI) will transform our approach to healthcare and provide opportunities for the pharmaceutical supply chain.

Serialization and track & trace processes generate a huge amount of data and pharmaceutical manufacturers need to have sufficient, secure and reliable data storage capacities. Data will need to be indexed and accessible for authorized personnel.

The Adents Serialization Summit provides a unique, collaborative forum for pharmaceutical leadership, and technology experts to discuss serialization and traceability in the pharmaceutical industry.

Pharmaceutical serialization and track & trace compliance requires time, effort and investment. Keep the hassle to a minimum with the right serialization solution and a knowledgeable vendor.

The US organization Healthcare Distribution Alliance (HDA) has built a central product master data repository called HDA Origin.

If analyzed wisely, serialization data analyzed through new technologies can help optimize supply chain processes and even build personalized connections with patients.

A new communiqué from the European Medicines Verification Organisation stresses the urgency for pharmaceutical companies to intensify compliance efforts regarding the Falsified Medicines Directive (2011/62/EU).

The European Medicines Verification Organization (EMVO) encourages pharmaceutical companies to set up their connection with the EU Hub as soon as possible to avoid bottleneck situations.

How can you ensure reliable connections & correct data exchange with all trading partners? Answers here....

“Grandfathering policy for packages and homogenous cases of product without a product identifier” is an FDA guidance document published in November 2017.

To make the pharmaceutical supply chain safer and ensure patients get the medicines they need, the Russian Ministry of Health intends to put in place serialization and aggregation requirements for drugs.

Latest trends, industry news and regulatory updates around pharmaceutical serialization, track&trace and supply chain efficiency - the key take-aways of Trackts! 2017

With more than 40 legislations in place or to come, compliance is...

In June 2017, the Drug Regulatory Authority of Pakistan (DRAP) has published its pharma supply chain requirements, making complete track& trace of each unit of sale and shipment compulsory by December 2020.

The US Food and Drug Administration (FDA) seems to be willing to give the pharmaceutical industry an additional grace period concerning the DSCSA.

FDA does not intend to take action against manufacturers who are not fully serialized by November 2017.

The Pharma CMO Summit in Lisbon in June was a good opportunity to touch base with the market and exchange news on serialization readiness-among CMOs.

To fight against this scourge, the European Union (EU) has put in place directive 2011/62/EU or Falsified Medicines Directive with which pharmaceutical manufacturers (whether MAH or CMO) as well as their supply chain partners will have to comply by early 2019.

The US Food and Drug Administration (FDA) has published guidance documents to help MAHs and CMOs navigate the Drug Supply Chain Security Act (DSCSA)

While the challenges of DSCSA compliance are undeniable, the right serialization and traceability solution can offer a multitude of benefits.

Even though the deadline for DSCSA compliance is only 6 months away, there is still some uncertainty as to who exactly will be concerned when by its requirements.

Serialization experts talk in levels. This helps them to break down and define the different components of serialization solutions and customer needs.

The Cloud platform of choice for European pharma authorities, Microsoft Azure will help pharmaceutical companies go beyond compliance.

In Brazil, serialization of pharmaceutical products and reporting to a national, centralized hub will be mandatory as per law 13.410.

Changing the paradigm of drug serialization: bottom-up vs top-down. Why you should rethink where you start analyzing your needs.

The Drug Supply Chain Security Act (DSCSA) will require many changes for your business and some of them will be highly complex. Change equates to risk. The greater the impact, the higher the level of risk.

The impact of Britain leaving the European Union or ‘Brexit’ negotiations is unclear. Where does this leave the pharmaceutical industry and what is the potential impact on the different players: pharma companies, CMOs, patients?

If you cater for the American market, you need to start putting together a serialization implementation strategy now if you want to be compliant and operational in time with the DSCSA requirements.

A Level 3 serialization application needs to have certain key functionalities to ensure the solution is durable.

While serialization projects look daunting, there are answers and solutions to make things go as smoothly as possible.

The latest industry report on "Pharmaceutical Serialization & Traceability 2016" has been published.

When thinking about implementing a serialization and track & trace solution, companies face all sorts of challenges and complexities.

New drug serialization requirements will soon make make packaging line print and verify mission-critical systems.

For many reasons, serialization within the pharmaceutical supply chain is absolutely essential. Discover

Serialization requirements following the implementation of the DSCSA in the United States or the FMD in Europe will raise new security concerns.

When serializing your products, you need to double-check the quality of your printed codes to ensure your supply chain can read them.

It is pretty clear that serialization at unit level is mandatory from November 2017 under the Drug Supply Chain Security Act (DSCSA). But what about other packaging levels?

Serialization regulations have set the way forward for major changes in the pharmaceutical industry which will gradually lead to a fully fraud and counterfeit-proof global supply chain.